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Study Objectives
Randomized phase III trial to compare the effectiveness of combination chemotherapy plus radiation therapy with or without gefitinib in treating unresectable stage III non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of tumors. It is not yet known whether combination chemotherapy plus radiation therapy is more effective with or without gefitinib in treating non-small cell lung cancer
Conditions: Adenocarcinoma of the Lung, Bronchoalveolar Cell Lung Cancer, Large Cell Lung Cancer, Squamous Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
Intervention / Treatment:
DRUG: cisplatin, DRUG: docetaxel, DRUG: etoposide, DRUG: gefitinib, RADIATION: radiation therapy, OTHER: placebo
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Either histologic or cytologic proof of a newly diagnosed single, primary bronchogenic non-small cell lung cancer is required (adenocarcinoma, non-lobar and non-diffuse bronchioloalveolar cell carcinoma, large cell carcinoma, or squamous cell carcinoma); a biopsy with histology is preferred, but cytology is allowed; histology or cytology from involved mediastinal or supraclavicular lymph nodes alone will be allowed if a separate distal primary lesion is clearly evident on radiographs (i.e., a second biopsy will not be required)
* Patients with brain metastases are ineligible; all patients must have a pretreatment CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to registration
* Patients with two or more parenchymal lesions on same or opposite sides of the lung are ineligible
* Patients must have unresectable Stage IIIA (N2) or Stage IIIB disease and also satisfy the following criteria:
* Unresectable Stage IIIA (N2) patients must satisfy the criteria:
* N2 mediastinal lymph nodes must be multiple and/or bulky on CT scan or X-ray, such that, in the opinion of the treating investigator, the patient is not a candidate for induction chemotherapy or chemoradiotherapy followed by surgical resection
* If Stage IIIA (N2), the N2 status must be documented by any one of the following methods:
* Histologic or cytologic proof of N2 disease by exploratory thoracotomy, thoracoscopy, mediastinoscopy, mediastinotomy, Chamberlain procedure, Wang needle biopsy, or fine needle aspiration (FNA) under bronchoscopic or CT guidance or other method
* Node positivity by FDG-PET scan
* Nodes > 3 cm on CT scan
* Paralyzed left true vocal cord with separate left lung primary distinct from AP window nodes on CT scan
* Stage IIIB patients must satisfy the following criteria; documentation of N3 or T4 status may be obtained by one or more of the following:
* Pathologically documented or radiographically documented positive N3 nodes; patients with positive supraclavicular or scalene lymph nodes must not have disease extending up into the cervical region
* Fine needle aspiration, core needle biopsy or excisional biopsy or supraclavicular N3 nodes
* Biopsy of contralateral mediastinal N3 nodes by mediastinoscopy, mediastinotomy or thoracotomy
* Fine needle aspiration, core needle or Wang needle biopsy under Ct or bronchoscopic fluoroscopic guidance of enlarged contralateral N3 mediastinal nodes
* Contralateral mediastinal nodes > 3 cm on CT scan
* Node positivity by FDG-PET scan
* Right sided primary with paralyzed left true vocal cord OR
* Any of the following T4 lesions: Tumor of any size that invades any of the following: mediastinum, heart, great vessels, trachea, esophagus, vertebral body or carina
* Written documentation of type of T4 extent by attending surgeon on either the operative report or as an addendum in the notes section of the prestudy form if patient has had an exploratory thoracotomy or thoracoscopy
* T4 involvement of trachea or carina by direct bronchoscopic visualization, documented on bronchoscopy report or as an addendum in the notes section of the prestudy form
* T4 involvement of heart, esophagus, aorta or vertebral body documented by CT scan, MRI or transesophageal ultrasound
* T4 involvement of the mediastinum may also be accepted by CT or MRI criteria if, in absence of the above organ involvement, there is soft tissue extension directly into the mediastinal space; radiographic criteria for involvement of main pulmonary artery or vein is allowed only if there is a mediastinal soft tissue mass
* Patients must not have malignant pleural effusions; NOTE: the only exception is pleural effusion only on CT scan (and not visible on CXR) OR deemed too small to tap
* Patients with pericardial effusions are ineligible
* All patients must have measurable or non-measurable disease documented by CT, MRI, X-ray or physical exam; measurable disease must be assessed within 28 days prior to registration and non-measurable disease assessed within 42 days prior to registration; pleural effusions and laboratory parameters are not acceptable as the only evidence of disease
* Patients must not have received any prior chemotherapy or radiotherapy for lung cancer; patients must not have had a previous surgical resection; however, patients may have undergone exploratory thoracotomy, mediastinoscopy, excisional biopsy or similar surgery for the purpose of determining diagnosis, stage, or potential resectability or newly diagnosed lung tumor
* Patients must have a measured or calculated creatinine clearance >= 50 cc/min
* The pre-registration FEV1 must be either >= 2.0 liters, OR if < 2.0 liters, the predicted FEV1 of the contralateral lung must be > 800 cc based on the quantitative split function testing within 42 days prior to registration
* WBC >= 3,000/ul
* ANC >= 1,200/ul
* Platelet count >= 100,000/ul
* All patients must have a CT of upper abdomen to exclude metastatic disease involving the contralateral chest, liver or adrenals (if chest CT is performed including complete liver and adrenals in the report, a separate CT of upper abdomen is not necessary) within 42 days prior to registration
* All patients must have a Zubrod Performance Status of 0 <= age <= 1
* Patients must have an EKG within 42 days prior to registration
* Institutions must have received IRB approval for S9925; Southwest Oncology Group, NCIC-CTG and CTSU patients must be offered participation in S9925 (the Lung Cancer Specimen Repository); patients registered by other groups may be offered participation in S9925 (at the discretion of the participating group)
* No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years
* If day 28 of 42 falls on a weekend or holiday, the limit may be extended to the next working day
* Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents; women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
* Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
* At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base
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NCT_ID
NCT00020709
|
Study_NameCombination Chemotherapy and Radiation Therapy With or Without Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
| 15,979 |
Study Objectives
This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.
Conditions: Non-small Cell Lung Cancer
Intervention / Treatment:
DRUG: Docetaxel, DRUG: Cisplatin, DRUG: Gemcitabine, DRUG: Erlotinib
Location: Spain
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: HEALTH_SERVICES_RESEARCH
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria:
* Patients age 18 years or more.
* Histologically confirmed diagnosis of non-small-cell lung carcinoma.(and indifferentiated and BAC histology).
* Only patients with advanced disease, defined as stage IV or IIIB with/without pleural effusion, will be included.
* Tumor sample available.
* A measurable lesion, as defined by RECIST criteria.
* Karnofsky score 60% or more (ECOG < 2).
* Patients should not have received previous treatment with chemotherapy or other agents for disseminated disease. Chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neoadjuvant treatment.
* Patients with cerebral disease are permitted, without any time limitations after holocranial irradiation or complementary antiedema treatment.
* Patients with hepatical, renal and hematology normality values.
* Patients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological samples of tumor and blood.
* Patients of childbearing age of either sex must use effective contraceptive methods (barrier methods or other birth control methods) before entering the study and while participating in the study.
* Patients must be available for clinical follow-up..
Exclusion Criteria:
* Patients who have received an investigational medicinal product in the 21 days before inclusion in the study or antiEGFR receptor agent.
* Severe comorbidity.
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NCT_ID
NCT00883480
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Study_NameIndividualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 Expression in Advanced Adenocarcinoma
| 3,051 |
Study Objectives
This randomized pilot clinical trial studies topical cryotherapy (cooling hands and feet with ice bags) in reducing pain in patients with chemotherapy induced peripheral neuropathy or paclitaxel induced acute pain syndrome. Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. Paclitaxel produces a disabling syndrome of acute aches and pains. Topical cryotherapy is being studied to see if it can help relieve pain from peripheral neuropathy or acute pain syndrome caused by chemotherapy.
Conditions: Breast Carcinoma
Intervention / Treatment:
PROCEDURE: Cryotherapy, DRUG: Paclitaxel, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Ability to complete questionnaires by themselves or with assistance
* Planned paclitaxel at a dose of 80 mg/m^2 intravenously (I.V.) given, in the adjuvant breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (NOTE: trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for poly adenosine diphosphate ribose polymerase [PARP] inhibitors), at the entering Academic and Community Cancer Research United (ACCRU) institution
* Life expectancy > 6 months
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Patient has score of 0 or 1 on the neurotoxicity evaluation, as determined by the healthcare provider
Exclusion Criteria:
* Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause
* Diagnosis of fibromyalgia
* Any prior exposure to neurotoxic chemotherapy
* History of Raynaud?s disease, cryoglobulinemia
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NCT_ID
NCT02640053
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Study_NameTopical Cryotherapy in Reducing Pain in Patients With Chemotherapy Induced Peripheral Neuropathy or Paclitaxel Induced Acute Pain Syndrome
| 22,075 |
Study Objectives
This is a multicenter, open-label, single-arm, expanded access treatment study designed to provide obinutuzumab to patients with previously untreated Chronic Lymphocytic Leukemia (CLL) in combination with chlorambucil and to evaluate the safety and efficacy of obinutuzumab administered in combination with chlorambucil. This study will enroll patients with previously untreated CD20-positive CLL requiring treatment according to the IWCLL guidelines (Hallek et al 2008), as assessed by the investigator.
Conditions: Chronic Lymphocytic Leukemia
Intervention / Treatment:
DRUG: Obinutuzumab, DRUG: Chlorambucil
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Confirmed diagnosis of CD20-positive CLL (per IWCLL guidelines, Hallek et al 2008)
* Previously untreated CLL requiring treatment according to the IWCLL guidelines (Hallek et al 2008), as assessed by the investigator
* Adequate baseline bone marrow function unless it due to underlying CLL disease No previous treatment for CLL by chemotherapy, radiotherapy, or immunotherapy
* Patients who are not appropriate to receive more intensive chemotherapy in the judgment of the investigator
* Life expectancy of > 6 months
Exclusion Criteria:
* Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to the start of Cycle 1
* Transformation of CLL to aggressive B-cell malignancy History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
* Known hypersensitivity to chlorambucil or any of its excipients
* History of other malignancy that could affect compliance with the protocol or interpretation of results Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of Cycle 1
* Major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
* Known infection with human immunodeficiency virus (HIV) or Human T-Cell Leukemia Virus 1 (HTLV-1) seropositive status
* Positive hepatitis serology
* Women who are pregnant or lactating
* Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
* Effective contraception is required while receiving obinutuzumab. For women, effective contraception is required to continue for >= 12 months after the last dose of obinutuzumab. For men, effective contraception is required to continue for 6 months after the last dose of chlorambucil treatment.
* Vaccination with a live vaccine a minimum of 28 days prior to the start of Cycle 1
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NCT_ID
NCT01868893
|
Study_NameAn Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia
| 19,508 |
Study Objectives
Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. This phase II trial is studying how well giving 3-AP together with cisplatin works in treating patients with recurrent or persistent platinum-resistant ovarian epithelial cancer or primary peritoneal cancer
Conditions: Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer
Intervention / Treatment:
DRUG: triapine, DRUG: cisplatin, OTHER: laboratory biomarker analysis
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histologically confirmed ovarian epithelial or primary peritoneal cancer
* Recurrent or persistent disease
* At least 1 unidimensionally measurable target lesion
* At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
* Outside a previously irradiated field
* Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or other organoplatinum compound) for primary disease
* Initial treatment may have included high-dose, consolidation, or extended therapy after surgical or non-surgical assessment
* Considered platinum resistant or refractory, according to 1 of the following criteria:
* Treatment-free interval of less than 6 months after platinum-based therapy
* Disease progression during platinum-based therapy
* Ineligible for any higher priority GOG protocol
* Performance status - GOG 0 <= age <= 2 (for patients who received 1 prior treatment regimen)
* Performance status - GOG 0 <= age <= 1 (for patients who received 2 prior treatment regimens)
* Absolute neutrophil count >= 1,500/mm^3
* Platelet count >= 100,000/mm^3
* SGOT and SGPT <= 2.5 times upper limit of normal (ULN)
* Bilirubin <= 1.5 times ULN
* Creatinine <= 1.5 times ULN
* No serious cardiac disease
* No prior myocardial infarction
* No uncontrolled congestive heart failure
* No pulmonary disease requiring oxygen
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Neuropathy (sensory and motor) <= grade 1
* No active infections requiring antibiotics
* No hearing impairment
* No known G6PD deficiency
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* At least 3 weeks since prior biologic or immunologic agents for malignant tumor
* One prior non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) allowed
* See Disease Characteristics
* One prior paclitaxel-containing regimen allowed
* No prior 3-AP
* No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
* Recovered from prior chemotherapy
* At least 1 week since prior hormonal therapy for malignant tumor
* Concurrent hormone replacement therapy allowed
* No prior radiotherapy to more than 25% of marrow-bearing areas
* Recovered from prior radiotherapy
* Recovered from prior surgery
* No prior cancer therapy that contraindicates receiving study therapy
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NCT_ID
NCT00081276
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Study_Name3-AP and Cisplatin in Treating Patients With Recurrent or Persistent Platinum-Resistant Ovarian Epithelial or Primary Peritoneal Cancer
| 14,599 |
Study Objectives
This phase I trial studies how well stereotactic body radiation therapy works in combination with tremelimumab and durvalumab in treating participants with cervical, vaginal, or vulvar cancers that have come back (recurrent) or spread to other areas of the body (metastatic). Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving stereotactic body radiation therapy, tremelimumab, and durvalumab may work better in treating participants with cervical, vaginal, or vulvar cancers.
Conditions: Advanced Cervical Adenocarcinoma, Advanced Vaginal Carcinoma, Advanced Vulvar Carcinoma, Human Papillomavirus-Related Cervical Squamous Cell Carcinoma, Human Papillomavirus-Related Vulvar Squamous Cell Carcinoma, Metastatic Cervical Adenocarcinoma, Metastatic Cervical Carcinoma, Metastatic Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Metastatic Vaginal Adenocarcinoma, Metastatic Vaginal Carcinoma, Metastatic Vulvar Carcinoma, Recurrent Cervical Adenocarcinoma, Recurrent Cervical Carcinoma, Recurrent Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Recurrent Vaginal Carcinoma, Recurrent Vulvar Carcinoma, Stage III Cervical Cancer AJCC v8, Stage III Vaginal Cancer AJCC v8, Stage III Vulvar Cancer AJCC v8, Stage IIIA Cervical Cancer AJCC v8, Stage IIIA Vulvar Cancer AJCC v8, Stage IIIB Cervical Cancer AJCC v8, Stage IIIB Vulvar Cancer AJCC v8, Stage IIIC Vulvar Cancer AJCC v8, Stage IV Cervical Cancer AJCC v8, Stage IV Vaginal Cancer AJCC v8, Stage IV Vulvar Cancer AJCC v8, Stage IVA Cervical Cancer AJCC v8, Stage IVA Vaginal Cancer AJCC v8, Stage IVA Vulvar Cancer AJCC v8, Stage IVB Cervical Cancer AJCC v8, Stage IVB Vaginal Cancer AJCC v8, Stage IVB Vulvar Cancer AJCC v8, Vaginal Squamous Cell Carcinoma, Not Otherwise Specified, Vulvar Adenocarcinoma, Vulvar Squamous Cell Carcinoma
Intervention / Treatment:
BIOLOGICAL: Durvalumab, OTHER: Laboratory Biomarker Analysis, RADIATION: Stereotactic Radiosurgery, BIOLOGICAL: Tremelimumab
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Written informed consent obtained from subject prior to any protocol related procedures
* Performance status Eastern Cooperative Oncology Group (ECOG) 0 <= age <= 2.
* Body weight > 30 kg
* Must have an average life expectancy of 6 months
* Patient is able and willing to comply with protocol and study procedures for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up visits
* Histological diagnosis of recurrent or metastatic cervical, vaginal, or vulvar cancer or an unknown pelvic malignancy most likely to have arisen from these sites as determined clinically by the treating physicians (i.e. squamous cell carcinoma or adenocarcinoma that is high risk [HR] human papillomavirus positive [HPV]+, but not limited to this example)
* Metastatic disease in at least two distinct lesions (including the index lesion to be treated) with at least one site outside of the radiation field and evaluable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria for evaluation of response
* At least one index lesion to be treated measuring 1 cm amenable to hypofractionated radiation therapy
* Staging computed tomography (CT) scans done prior to enrollment
* Have had at least one line of prior platinum-based systemic chemotherapy once diagnosed with recurrence or metastatic disease if primary cervical cancer. If a patient has primary vulvar or vaginal cancer, there is not a requirement.
* May have received 1 prior biologic regimen (i.e. avastin) but not within 4 weeks of enrollment
* Full recovery from the acute effects of prior treatments, defined as effects having resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03 grade 0 or 1 with the exception of alopecia and certain laboratory values as outlined below; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by durvalumab and tremelimumab may be included (e.g., hearing loss, neuropathy) upon approval of the principal investigator (PI)
* In patients with central nervous system (CNS) metastases, metastases must be asymptomatic at the time of day 1 of the study and meet the following criteria:
* Brain metastases should have been treated with either whole brain radiation therapy (WBRT), stereotactic radiosurgery (SRS)/gamma-knife, or surgical resection;
* At least 28 days without progression of CNS metastases as evidenced by magnetic resonance imaging (MRI) or CT from last day of treatment with radiation to the CNS metastases;
* At least 3 months from surgical resection (if had surgery) with stability on MRI brain at enrollment;
* At least 14 days since last dose of corticosteroids;
* Must not have leptomeningeal disease or cord compression
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN); for subjects with liver metastasis, ALT and AST =< 5 x ULN within 3 weeks prior to initial treatment
* Total bilirubin =< 1.5 x ULN except in patients with documented Gilbert's syndrome or liver metastasis, who must have a baseline total bilirubin =< 3.0 mg/dl within 3 weeks prior to initial treatment
* Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance within 3 weeks prior to initial treatment
* Negative screening test results for hepatitis B, hepatitis C, and human immunodeficiency virus
* Absolute neutrophil count (ANC) >= 1,500 cells/ul without growth factor support prior to initial treatment
* Hemoglobin >= 9 g/dL prior to initial treatment
* Platelet count >= 100,000 platelets/ul prior to initial treatment
* Subjects must either be of non-reproductive potential (ie, post-menopausal by history; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum or urine pregnancy test upon study entry; women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause; the following age-specific requirements apply:
* Women < 50 years would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy); they would also be considered had radiation-induced or chemotherapy-induced menopause with last menses > 1 year ago
* Women >= 50 years would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)
* Women of any age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced or chemotherapy-induced menopause
* Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective method of contraception from the time of screening, and must agree to continue using such precautions for 180 days after the final dose of durvalumab and tremelimumab; cessation of contraception after this point should be discussed with a responsible physician; they must also refrain from egg cell donation for 180 days after the final dose of durvalumab and tremelimumab
* Note: A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly; the acceptable methods of contraception include barrier methods (male condom plus spermicide, copper T intrauterine device, levonorgesterel-releasing intrauterine system) or hormonal methods (implants, hormone shot or injection, combined pill, minipill, patch)
Exclusion Criteria:
* Involvement in the planning and/or conduct of the study
* Previous enrollment in the present study
* Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of durvalumab + tremelimumab combination therapy
* Prior treatment with an anti-CTLA-4, including tremelimumab PD-1 or PD-L1 inhibitor, including durvalumab
* Prior oncology vaccine therapy
* Prior radiation treatment to the index lesion to be treated
* Prior radiation which overlaps and precludes hypofractionated treatment to the index lesion
* Treatment with other investigational agent within 4 weeks to the first dose of tremelimumab or durvalumab
* Concomitant therapy with any of the following: interleukin-2 (IL-2), interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; all such therapies must have been discontinued > 4 weeks
* Any unresolved toxicity (CTCAE grade < 2) from previous anti-cancer therapy; (subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy)
* Any prior grade >= 3 immune-related adverse event (imAE) while receiving any previous immunotherapy agent, or any unresolved imAE > grade 1
* Treatment with a vascular endothelial growth factor (VEGF) inhibitor within the last 6 weeks
* Major surgical procedure (as defined by the treating physician) within 28 days prior to the first dose of durvalumab and tremelimumab or still recovering from prior surgery
* Active cardiac disease defined as unstable angina, uncontrolled hypertension, myocardial infarction in the last six months (unless successfully treated with coronary artery bypass grafting [CABG] or percutaneous transluminal coronary angioplasty [PTCA]), uncontrolled arrhythmia, or symptomatic congestive heart failure; > 3 heart-related hospitalizations in the past year
* Mean QT interval corrected for heart rate (QTc) >= 470 ms calculated from 3 electrocardiogram (ECGs) using Fridericia's correction from triplicate ECGs in those patients who have an initial abnormal EKG on screening
* Severe chronic obstructive pulmonary disease (COPD) requiring > 3 hospitalizations in the past year
* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]); the following are exceptions to this criterion:
* Patients with vitiligo or alopecia;
* Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement;
* Any chronic skin condition that does not require systemic therapy;
* Patients without active disease in the last 5 years may be included but only after consultation with the study physician;
* Patients with celiac disease controlled by diet alone
* Active or prior documented interstitial lung disease
* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab and tremelimumab with the exceptions of intranasal and inhaled corticosteroids, systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent, or steroids used transiently to control contrast agent allergies for radiographic studies
* History of allogeneic organ transplant
* History of hypersensitivity to durvalumab or tremelimumab or any CTLA4, PD1, or PDL-1 inhibitor
* Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab or tremelimumab
* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies); patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible; patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
* History of prior bowel fistula, ulcerations, or perforations
* Evidence of progressive or symptomatic central nervous system (CNS) metastases or leptomeningeal disease
* Uncontrolled inter-current illness, including, but not limited to, ongoing or active infection requiring systemic treatment, current or history of prior radiation induced pneumonitis, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirement or compromise the ability of the subject to give written informed consent
* Other active invasive malignancy; history of non-invasive malignancies such as ductal carcinoma in situ of the breast, non-melanomatous carcinoma of the skin, is allowed, as is history of other invasive malignancy that is in remission for >= 5 years after treatment with curative intent
* Any medical, psychological, or social condition that, in the opinion of the treating physician would interfere with evaluation of the investigational product or interpretation of subject safety or study results
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NCT_ID
NCT03452332
|
Study_NameStereotactic Body Radiation Therapy, Tremelimumab and Durvalumab in Treating Participants With Recurrent or Metastatic Cervical, Vaginal, or Vulvar Cancers
| 15,328 |
Study Objectives
This phase II trial is studying how well lenalidomide works in treating older patients with acute myeloid leukemia with abnormal chromosome 5q. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.
Conditions: Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: lenalidomide
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Morphologically confirmed diagnosis of acute myeloid leukemia (AML) by bone marrow aspiration and biopsy within the past 14 days
* Diagnostic biopsy within the past 28 days with marrow blast percentage >= 70% allowed provided no potentially antileukemic therapy was received after biopsy
* Cytogenetic evidence of del (5q) abnormality by conventional karyotyping or fluorescence in situ hybridization (FISH)
* Previously untreated disease
* Must have declined standard AML cytotoxic chemotherapy regimens
* WBC <= 30,000/mm³
* History of prior myelodysplastic syndromes (MDS) allowed
* No acute promyelocytic leukemia (FAB M3)
* No blastic transformation of chronic myelogenous leukemia
* Zubrod performance status 0 <= age <= 2
* Bilirubin <= 2.5 times upper limit of normal (ULN) (unless elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis, but not to liver dysfunction)
* AST and ALT <= 3.5 times ULN
* Creatinine <= 1.5 times ULN
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 forms of effective contraception at least 4 weeks prior to, during, and for 4 weeks after completion of study treatment
* No known allergy to thalidomide
* Concurrent enrollment on SWOG-S9910 allowed (for SWOG patients)
* No prior systemic chemotherapy for acute leukemia except hydroxyurea
* Single-dose intrathecal chemotherapy allowed before or concurrently with induction chemotherapy
* No prior AML induction-type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support
* Prior hematopoietic growth factors, thalidomide, arsenic trioxide, signal-transduction inhibitors, azacitidine, and low-dose cytarabine (i.e., < 100 mg/m²/day) for treatment of MDS allowed
* At least 30 days since prior therapy for MDS (excluding growth factors)
* No prior lenalidomide for MDS
* At least 6 months since prior chemotherapy or radiotherapy for another malignancy
* No concurrent therapy for another malignancy
* Concurrent hormonal therapy allowed
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NCT_ID
NCT00352365
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Study_NameLenalidomide in Treating Older Patients With Acute Myeloid Leukemia
| 2,491 |
Study Objectives
The primary objective of this study was to compare the effectiveness of darbopoetin alfa to placebo in the treatment of anemia in adults with lung cancer receiving multicycle platinum-containing chemotherapy, by assessing the percentage of participants who received red blood cell (RBC) transfusions during weeks 5-12 inclusive.
Conditions: Anemia
Intervention / Treatment:
DRUG: Darbepoetin alfa, DRUG: Placebo
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Lung cancer (either small cell [SCLC] or non-small cell [NSCLC])
* At least 12 additional weeks of platinum containing cyclic chemotherapy planned regardless of cycle length
* Anemia (hemoglobin <= 11.0 g/dL) as assessed by a local or central laboratory result within 7 days before study day 1 (the first scheduled day of on-study chemotherapy and the first day of study drug administration)
* Life expectancy of at least 6 months, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Anemia predominantly due to the cancer or chemotherapy (i.e.. serum folate >= 4.5 nmol/L (>= 2.0 ng/mL) and vitamin B 12 >= 148 pmol/L (>= 200 pg/mL), no overt hemolysis, and no overt gastrointestinal bleeding or bleeding due to recent surgery)
* Adequate renal function (creatinine <= 177gmol/L (<= 2.0 mg/dL) and adequate hepatic function (bilirubin <= 1.5 times central laboratory's upper limit of normal range)
* Available for 4 weeks post administration of the last dose of study drug
* Legal age for informed consent, and written informed consent must be obtained
Exclusion Criteria:
* History of any primary hematological disorder which could cause anemia (e.g., sickle cell anemia)
* Received prior whole pelvis radiation therapy
* Uncontrolled angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%)], or uncontrolled cardiac arrhythmia.
* History of primary or metastatic malignancy involving the central nervous system (CNS). Subjects with a previous history of primary or metastatic malignancy involving the CNS will be eligible for the study providing they have had no clinical signs of nor treatment for CNS disease and no history of seizures within previous 2 years
* Uncontrolled hypertension (i.e., diastolic blood pressure > 100 mm Hg)
* History of seizures. Subjects with a previous history of seizures will be eligible for the study providing they have had no evidence of seizure activity and have been free of anti-seizure medication for the previous 5 years
* Evidence of clinically significant systemic active infection or chronic inflammatory disease (e.g., rheumatoid arthritis)
* Iron deficiency (transferrin saturation < 15% and ferritin < 10 μg/L (< 10 ng/mL))
* Received > 2 RBC transfusions within 4 weeks before randomization or any RBC transfusion within 2 weeks before randomization
* Received erythropoietin therapy within 8 weeks before randomization
* Known positive test for human immunodeficiency virus (HIV) infection
* Receiving, or not yet 30 days past the end of receiving, another investigational agent or device not approved in any indication.
* Pregnant or breast feeding females.
* Not using adequate contraceptive precautions
* Prior treatment with NESP
* Previously randomized in this study
* Known hypersensitivity to mammalian-derived product
* Concerns for subject's compliance with the protocol procedure, including completion of the quality of life surveys (QOLS)
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NCT_ID
NCT03776032
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Study_NameA Novel Erythropoiesis Stimulating Protein (NESP; Darbopoetin Alfa) for the Treatment of Anemia in Lung Cancer Patients Receiving Multi-cycle Platinum-Containing Chemotherapy
| 15,338 |
Study Objectives
The objective of this study is to establish the recommended dose of selumetinib, a novel MEK inhibitor for use in combination with gemcitabine and cisplatin.
Conditions: Biliary Tract Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms
Intervention / Treatment:
DRUG: selumetinib, DRUG: gemcitabine, DRUG: cisplatin
Location: United Kingdom
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* A histopathological or cytological diagnosis of non-resectable, recurrent or metastatic biliary tract (intra- or extra-hepatic), gallbladder or ampullary carcinoma
* ECOG performance status 0, 1, or 2
* Age >= 18
* Estimated life expectancy > 3 months
* Adequate haematological function:
* Haemoglobin 9g/dL (prior transfusions for patients with low haemoglobin are allowed)
* WBC >= 3.0 x 10*9/L
* Absolute neutrophil count (ANC) >= 1.5 x 10*9/L
* Platelet count >= 100 x 10*9/L
* Adequate liver function:
* Total bilirubin <=1.5 x upper limit of normal (ULN) OR <= 3.0 x upper limit of normal (ULN) if stable for a duration of two weeks
* ALT and/or AST & alkaline phosphatase <= 5 x ULN
* Adequate renal function:
* Serum urea and serum creatinine < 1.5 times ULN
* Calculated GFR >= 45 mL/min. If the calculated GFR is below 45ml/min, isotope EDTA confirmation of adequate renal function is required
* Capable of giving written informed consent
* Prior therapy is allowed (provided there has been a full recovery):
* Surgery (non-curative operation), must have evidence on nonresectable disaes progression prior to trial entry
* Radiotherapy, must have clear evidence of disease progression prior to inclusion
* Prior adjuvant chemotherapy is allowed provided neither gemcitabine nor cisplation were used and treatment was completed 28 days prior to trial entry.
Exclusion Criteria:
* Any prior exposure to MEK, Ras, or Raf inhibitors
* Cardiac conditions as follows:
* Uncontrolled hypertension (BP >=150/95 despite optimal therapy)
* Heart failure (NYHA Class II or above)
* Prior or current cardiomyopathy
* Baseline LVEF <=50%
* Atrial fibrillation with heart rate >100 bpm
* Unstable ischaemic heart disease (MI within 6 months prior to starting treatment, or angina requiring use of nitrates more than once weekly).
* Incomplete recovery from previous surgery.
* Patients undergoing current treatment with curative intent.
* History of prior malignancy that could interfere with the response evaluation (exceptions include in-situ carcinoma of the cervix treated by cone-biopsy/resection, non-metastatic basal and/or squamous cell carcinomas of the skin, any early stage (stage I) malignancy adequately resected for cure greater than 5 years previously).
* Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial.
* Any psychiatric or other disorder (e.g brain metastases) likely to impact on informed consent.
* Pregnancy or breast-feeding. Women of child-bearing potential should must have a negative pregnancy test prior to study entry AND be using an adequate contraception method, which must be continued for 3 months after completion of chemotherapy
* NB. Whilst not excluded, patients with significant impaired hearing must be made aware of potential ototoxicity and may choose not to be included. If included, baseline audiograms are recommended and should be followed by repeat audiograms prior to cycle 2.
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NCT_ID
NCT01242605
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Study_NameABC-04 a Study of Cisplatin, Gemcitabine and Selumetinib in Patients With Advanced Biliary Tract Cancer
| 20,238 |
Study Objectives
To evaluate objective response rate and duration of response to weekly Taxoprexin®.
To evaluate the safety profile of weekly Taxoprexin® in this patient population.
To evaluate overall survival in the same patient population. To evaluate time to disease progression, and the time to treatment failure in patients with metastatic choroidal melanoma being treated with weekly Taxoprexin® Injection.
Conditions: Metastatic Melanoma
Intervention / Treatment:
DRUG: Taxoprexin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Patients must have histologic or cytologic confirmation of malignant eye melanoma, and documented metastatic disease.
* Patients must have at least one unidimensionally measurable lesion.
* Patients may be previously untreated or may have received one prior systemic chemotherapy regimen for metastatic disease. Patients may not have been treated previously with taxanes. Prior treatment with immunotherapy or vaccine therapy is allowed.
* At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy.
* At least 4 weeks (28 days) since prior radiotherapy to > 20% of the bone marrow and prior adjuvant chemotherapy.
* Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy.
* Patients must have ECOG performance status of 0 - 2.
* Patients must be at least 13 years.
* Patients must have adequate liver and renal function.
* Patients must have adequate bone marrow function.
* Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution.
-
Exclusion Criteria:
* Patients who have received prior therapy with any taxane.
* Patients whose site of primary melanoma is not in the choroid(eye).
* Patients who have a past or current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers treated for cure and with a disease-free survival longer than 5 years.
* Patients with symptomatic brain metastasis (es).
* Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. Patients may not breastfeed while on this study.
* Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
* Patients with current peripheral neuropathy of any etiology that is greater than grade one (1).
* Patients with unstable or serious concurrent medical conditions are excluded.
* Patients with a known hypersensitivity to Cremophor.
* Patients with Gilbert's Syndrome.
* Patients must not have had major surgery within the past 14 days.
* Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study.
* Known HIV disease or infection.
-
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NCT_ID
NCT00244816
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Study_NameTaxoprexin® Treatment for Advanced Eye Melanoma
| 4,777 |
Study Objectives
Aim of this study is to provide the "proof of concept" of efficacy and tolerability of lurbinectedin monotherapy in progressive malignant mesotheliomas.
Conditions: Malignant Pleural Mesothelioma, Advanced
Intervention / Treatment:
DRUG: Lurbinectedin
Location: Italy, Switzerland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
* Histologically confirmed malignant mesothelioma (all histologies are eligible)
* Progression on or after one line of platinum-based combination chemotherapy. Any previous treatment with surgery or radiotherapy is allowed
* <= 1 line of treatment with an immune checkpoint inhibitor
* Prior systemic treatment stopped at least 4 weeks before registration
* Measurable or evaluable disease according to the modified RECIST criteria for malignant pleural mesothelioma
* Age >= 18 years
* ECOG performance status <= 1
* Adequate bone marrow function: hemoglobin >= 90 g/L; absolute neutrophil count >= 2 x 109/L, platelet count >= 100 x 109/L
* Adequate hepatic function: total bilirubin <= 1.5 ULN (except for patients with Gilbert's disease <= 3.0 x ULN); aspartate aminotransferase and alanine aminotransferase <= 3.0 x ULN; albumin >= 30 g/L
* Adequate renal function: creatinine clearance >= 30 mL/min/1.73, calculated according to the corrected formula of Cockcroft-Gault
* Women with child-bearing potential are using effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment and during 6 months thereafter. A negative pregnancy test before registration (within 7 days) into the trial is required for all women with child-bearing potential
* Men agree not to father a child during trial treatment and during 6 months after last treatment infusion.
Exclusion Criteria:
* Known brain or leptomeningeal metastases
* History of another hematologic or primary solid tumor (except for curatively treated basal or squamous cell carcinoma of the skin, properly treated in situ malignant melanoma, in situ carcinoma of the uterine cervix or pT1 <= age <= 2 prostate cancer with Gleason score <=6) within five years prior to registration
* More than one previous line of chemotherapy. Re-challenge is not allowed
* Prior treatment with lurbinectedin or trabectedin
* Treatment with any other experimental drug within 4 weeks before registration
* Concomitant use of other anti-cancer drugs, anti-cancer surgical intervention or radiotherapy except for local pain control and/or other local symptoms (e.g. pleurodesis due to dyspnea)
* Grade > 1 from any AE derived from previous treatment; alopecia any grade, grade <= 2 peripheral neuropathy and clinically not significant elevation of GGT grade <= 2 (according to the NCI-CTCAE v4.03) are allowed
* Treatment with cortisone (prednisolone > 10 mg or equivalent) for immune-mediated side effects from previous immunotherapy (if applicable)
* Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV), unstable angina pectoris, history of myocardial infarction within the last six months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia)
* Severe or uncontrolled endocrinopathy due to previous immune checkpoint inhibitor treatment (if applicable)
* Known history of human immunodeficiency virus or active chronic hepatitis C or hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous antimicrobial treatment
* Known hypersensitivity to the trial drug or to any component of the trial drug
* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
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NCT_ID
NCT03213301
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Study_NameLurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma.
| 9,907 |
Study Objectives
Carcinoma of the gallbladder is the commonest malignancy of the biliary tract. Higher incidence has been noted in Chile, Mexico and Southwest American Indians.\[1\] It is the third most common malignancy in India.\[2\] The disease may mimic benign disease in presentation.Up to 1/3rd of patients may present with jaundice but of these only 7% will be resectable.\[4\] With aggressive surgical resection, actuarial 5 year survival of 83% for stage II disease and 63% for stage III have been reported.\[5\] Treatment of choice is complete surgical resection.
The role of chemotherapy and radiotherapy is not very well documented in treatment of gallbladder cancer. Because of the propensity of gallbladder carcinoma to spread to regional lymph nodes at an early stage and the high rate of loco regional recurrence, adjuvant chemotherapy or chemo-radiotherapy seems a rational therapeutic option. Gemcitabine with or without Cisplatin has been increasingly used. In a recent paper Gemcitabine with Cisplatin was found to be more effective than gemcitabine alone and provides definite survival advantage and progression free survival.\[6\] An earlier randomized trial done to assess the efficacy of the adjuvant chemotherapy for the pancreato-biliary cancer reported improvement in disease free and overall 5 year survival.\[7\] But this study has included patients with suboptimal resection and all pancreato-biliary malignancy.
In view of these observations this study is being designed to assess the efficacy of the chemotherapy in the adjuvant setting in gallbladder cancer patients who have undergone curative resections.
Conditions: Gallbladder Cancer
Intervention / Treatment:
DRUG: Gemcitabine + Cisplatin
Location: India
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria:
* T1b and above adenocarcinoma of gall bladder
* Patients undergoing curative resection
* Incidentally diagnosed carcinoma who have undergone curative completion radical cholecystectomy
Exclusion Criteria:
* T1a tumors
* Patients with metastatic disease
* Patients unfit to undergo chemotherapy
* Patients unwilling to undergo the trial
* Patients with double cancers
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NCT_ID
NCT02778308
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Study_NameAdjuvant Chemotherapy vs no Chemotherapy for Patients With GallBllader Carcinoma
| 17,532 |
Study Objectives
Prospective, non-randomized, multi-center study to assess the efficacy and safety of paricalcitol injection or oral administered over 6 months to patients with secondary hyperparathyroidism on dialysis.
Conditions: Secondary Hyperparathyroidism, Dialysis
Intervention / Treatment:
DRUG: Paricalcitol injection, DRUG: Paricalcitol capsules
Location: Mexico
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Patients >=18 years with secondary hyperparathyroidism (iPTH >= 300 pg/mL)
* Patients in a chronic hemodialysis or peritoneal dialysis program previously treated with vitamin D metabolites or without previous treatment
* Patients in which treatment with paricalcitol injection or oral is clinically indicated according to the criteria of the participating investigator
* Patients providing their signed informed consent to participate in the trial
Exclusion Criteria:
* Patients with severe hyperparathyroidism (iPTH > 3,000 pg/ml)
* Patients with hypercalcaemia (calcium >=11.0 mg/dl, adjusted according to Albumin level), hyperphosphataemia (phosphorus >= 6.5 mg/dl) or patients with calcium x phosphorus >= 70
* Known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients
* Patients who have participated in clinical studies within the last month or who are currently enrolled in clinical studies
* Patients who cannot tolerate or take phosphorus binders that do not contain Calcium and/or Aluminum
* Patients that in the opinion of the investigator, for any reason, are not good candidates for therapy with Synthetic Analogues of Vitamin D
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NCT_ID
NCT00537979
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Study_NameEfficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis
| 16,958 |
Study Objectives
The purpose of the study is to investigate the response rate for triple negative breast cancer patients with brain metastasis when INIPARIB is used in combination with irinotecan.
Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
Conditions: Estrogen Receptor Negative (ER-Negative) Breast Cancer, Progesterone Receptor Negative (PR-Negative) Breast Cancer, Human Epidermal Growth Factor Receptor 2 Negative (HER2-Negative) Breast Cancer, Brain Metastases
Intervention / Treatment:
DRUG: INIPARIB + irinotecan
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria -
* Histologically-confirmed, ER negative, PR negative and Her2 negative adenocarcinoma of the breast with brain lesion on radiographic imaging.
* ECOG Performance Status of 0 <= age <= 2.
* Life expectancy of >12 weeks.
* No limit to prior therapies with last anti-cancer treatment >= 2 weeks from initiation of protocol-based therapy provided all toxicities (other than alopecia) have resolved to <=Grade 1 or baseline.
* No active serious infection or other comorbid illness which would impair ability to participate in the trial.
* Stable or decreasing dose of steroids for >= 7 days.
* Interval >= 4 weeks between open brain biopsy and initiation of protocol-based therapy.
* Patients must have adequate organ function.
Exclusion Criteria -
* Pregnant or breast-feeding
* Prior allergic reaction to INIPARIB
* Prior allergic reaction to irinotecan.
* Evidence of hemorrhage or impending herniation on baseline brain imaging
* Evidence of diffuse leptomeningeal disease on brain MRI or by previously documented CSF cytology-NOTE: discrete dural metastases are permitted.
* Clinically significant cardiac, renal, hepatic, infectious or pulmonary disease which might affect trial participation.
* Concurrent or planned radiation, hormonal, chemotherapeutic, experimental or targeted biologic therapy.
* Contraindication to gadolinium-enhanced MRI imaging.
* Inability to comply with study and/or follow-up procedures.
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NCT_ID
NCT01173497
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Study_NameA Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis
| 20,153 |
Study Objectives
To improve progression free survival in high risk patients with resected pancreatic adenocarcinoma who have node positive disease, margin positive disease, and/or elevation in CA 19-9 treated with CC-486 (oral azacitidine) as compared to observation after completion of adjuvant therapy.
Conditions: Pancreatic Cancer
Intervention / Treatment:
DRUG: oral azacitidine, OTHER: Observation
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Understand and voluntarily sign an informed consent form.
* Age greater than or 18 years at the time of signing the informed consent form.
* Able to adhere to the study visit schedule and other protocol requirements.
* Subjects must have a histologically confirmed pancreatic adenocarcinoma that has had an R0 (negative margins) or R1 (microscopically positive margins) resection.
* Subjects must have finished adjuvant therapy, which can include chemotherapy and/or chemoradiation therapy or have been determined to be unable to take adjuvant therapy. Although patients will be expected to complete chemoradiation or chemotherapy per physician recommendations, patients who are unable to complete chemotherapy ± radiation therapy secondary to dose limiting toxicities will be eligible provided they meet study criteria.
* Subjects enrolled due to node + disease or R1 resection must be able to undergo randomization within 3 months of finishing adjuvant therapy or the decision that they are unable to take adjuvant therapy. Patients enrolling due to CA 19 <= age <= 9 elevations can enroll any time after adjuvant therapy has completed.
* All previous cancer therapy including radiation, chemotherapy, and surgery, must have been discontinued at least 4 weeks prior to treatment in this study
* Subjects must either have a CA 19 <= age <= 9 value > the institutional ULN on two separate checks at least 2 weeks apart OR have had an R1 resection margin OR N1 nodal disease regardless of CA 19 <= age <= 9 level
* Subjects must be free of visible disease on imaging (CT, PETCT or MRI) evaluating chest, abdomen, and pelvis within 28 days of enrollment on the study.
* Life expectancy of greater than 12 weeks
* ECOG performance status of less than or equal to 1 at study entry
* Subjects must have normal organ and marrow function
* Free of prior malignancies for greater than or equal to 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.
* Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with CC-486 or nab-paclitaxel. All men and women of childbearing potential must use effective methods of birth control throughout the study and for three months after completing treatment.
* Women of childbearing potential must have a negative serum or urine β-hCG pregnancy test at screening.
* Subjects must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE)
Exclusion Criteria:
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
* Pregnant or breastfeeding women.
* Use of any other chemotherapy, radiotherapy, or experimental drug or therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to enrollment on study or those who have not recovered from adverse events >= grade 1 due to agents administered more than 4 weeks earlier except for stable grade 2 neuropathy.
* Subjects may not receive any other concomitant investigational agents.
* Known or suspected hypersensitivity to 5-azacitidine or mannitol
* Known positive for HIV or infectious hepatitis, type B or C. HIV patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Any known gastrointestinal disorders which would preclude oral administration of 5-azacitidine.
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NCT_ID
NCT01845805
|
Study_NameTrial to Improve Outcomes in Patients With Resected Pancreatic Cancer (Azacitidine)
| 20,530 |
Study Objectives
The roles of imaging in cancer may be divided into that of diagnosis and tumour detection, staging and assessment of response to treatment. Standard radiological techniques include ultrasound, Computed Tomography (CT), Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET). A combination of imaging techniques is often necessary to differentiate between cancerous and normal tissue. Traditional imaging techniques identify cancers by their gross appearance and structural/ cellular characteristics, whilst PET do so by tracking glucose metabolism. PET owes its specificity to the high rate of glucose metabolism seen in most cancers. However it is not used routinely due to a lack of availability and high costs. In addition, PET is often used in combination with CT, which imparts a significant diagnostic radiation dose. This can increase an individual's risk of cancer, especially with childhood or early adult exposure. In contrast, MRI is more readily available and does not involve radiation. However its ability to detect cancer by tracking glucose metabolism has not been widely explored. Our group has recently developed a novel MRI technique called Gluco-CEST that can image glucose delivery, uptake and metabolism in cancer, therefore potentially allowing a radiation-free, one-stop imaging service that can be adapted to current generation of MRI scanners. This study aims to optimise the GlucoCEST technique, after which it will be rigorously tested and compared to standard imaging parameters and clinical or pathological reference standards to evaluate its diagnostic and predictive power across a number of cancer populations.
Conditions: Head and Neck Squamous Cell Carcinoma, Lymphoma, Glioma
Intervention / Treatment:
OTHER: Glucose infusion, DIAGNOSTIC_TEST: Magnetic Resonance Imaging (MRI), DIAGNOSTIC_TEST: FDG PET
Location: United Kingdom
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: BASIC_SCIENCE
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE
|
Inclusion Criteria:
* Healthy Volunteers:
1. No previous history of cancer
2. No known renal impairment or an eGFR within a standard reference value if there is a history of renal disease.
3. Aged 18 or over with capacity to consent.
* Patient groups:
1. Confirmed diagnosis of selected cancer types (head and neck, lymphoma and glioma)
2. No known renal impairment or an eGFR within a standard reference value if there is a history of renal disease
3. Aged 18 or over with capacity to consent.
Exclusion Criteria:
* For both groups:
1. Confirmed diagnosis of selected cancer types (head and neck, lymphoma and glioma)
2. Pregnancy
3. Contradiction to MRI magnetic field (pacemaker, metallic implant, severe claustrophobia, etc)
4. Allergy to MR contrast agent (Gadolinium)
5. Adult with Impaired capacity
6. Deranged renal function with eGFR
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NCT_ID
NCT03212157
|
Study_NameGlucoCEST MRI in Oncology
| 853 |
Study Objectives
To assess and quantify the changes in bone mineral density between the ARIMIDEX and ARIMIDEX plus NOLVADEX groups when compared to the NOLVADEX alone treatment group whilst receiving trial therapy.
Conditions: Bone Density
Intervention / Treatment:
DRUG: Anastrozole, DRUG: Tamoxifen
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Eligible for entry into the main ATAC trial 1033IL/0029
* Women defined as post-menopausal
* Patients with histologically proven operable invasive breast cancer
* Who following primary surgery have a good prognosis and would be ethically suitable to remain untreated
Exclusion Criteria:
* Excluded from entry into the main ATAC trial (1033IL/0029)
* Patients who have received hormone replacement therapy within the previous 12 months prior to randomisation
* Patients who have received bisphosphonate therapy within the previous 12 months prior to randomisation
* Patients who have had a bone fracture within the previous 6 months prior to randomisation
|
NCT_ID
NCT00784940
|
Study_NameATAC - Bone Density Sub-Protocol
| 10,966 |
Study Objectives
The main purpose of this study is to find out what effects (good or bad) trabectedin (ET743) has on men with advanced prostate carcinoma.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: ET 743
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the prostate
* Radiographically documented metastatic disease
* Surgical or chemical castration
* Prostate specific antigen (PSA) > 5 ng/ml
* Castration resistant prostate cancer (CRPC)
* One previous taxane-based chemotherapy regimen
* Eastern Cooperative Group (ECOG) performance status 0,1 or 2
* Neutrophil count > 1,500/ul
* Platelet count > 100,000/ul
* Serum bilirubin < 1.0 x upper limit normal (ULN)
* Serum alkaline phosphatase < 1.5 x ULN
* Asparate aminotransferase/Alanine aminotransferase < 2.5 x ULN
* Albumin > 2.5 g/dl
* Serum creatinine < 1.5 x ULN
* Prior hormonal therapy
Exclusion Criteria:
* Chemotherapy treatment within 4 weeks of study entry
* Patient not employing adequate contraception
* Serious illness or medical conditions, specifically: uncontrolled congestive heart failure or history of myocardial infection or active angina pectoris within 6 months; active infectious process; chronic active liver disease, including chronic hepatitis B, C or cirrhosis
* Current anti-cancer treatment with any non-FDA approved investigational drug
|
NCT_ID
NCT00147212
|
Study_NameET 743 (Yondelis) in Men With Advanced Prostate Cancer
| 13,121 |
Study Objectives
The primary objectives of this study are to investigate the safety and tolerability of BAY 1841788 in Japanese subjects with metastatic castration-resistant prostate cancer (mCRPC) and the PK of BAY 1841788 and its major metabolite BAY 1896953.
Conditions: Prostatic Neoplasms
Intervention / Treatment:
DRUG: BAY 1841788(ODM-201)
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Japanese males aged >= 20 years
* Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features
* Patients with metastatic castration-resistant prostate cancer (mCRPC). CRPC is defined as follows
* Ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (LHRH) analogue or antagonist, or bilateral orchiectomy, and castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dL]) at screening AND
* Progressive disease and/or prostate-specific antigen (PSA) increase of three consecutive rises, at least 1 week apart AND
* PSA > 2ng/mL at screening
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 <= age <= 1
* Life expectancy of at least 3 months
* Blood counts at screening: haemoglobin >= 9.0 g/dL, absolute neutrophil count >= 1,500/μL (1.5x109/l), platelet count >= 100,000/μL (100x109/l) (patient must not have received any growth factor or blood transfusion within 7 days of the hematology laboratory obtained at screening)
* Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) <= 2.5 x upper limit of normal (ULN), total bilirubin <= 1.5 x ULN, creatinine <= 1.5 x ULN, albumin > 3.0 g/dl
* Prior treatment with antiandrogen. Discontinuation of bicalutamide or nilutamide (not approved in Japan) at least 6 weeks and other antiandrogens at least 4 weeks prior to the start of the study drug administration.
Exclusion Criteria:
* Known metastases in the brain
* Symptomatic local-regional disease that requires medical intervention including moderate/severe urinary obstruction or hydronephrosis due to prostate cancer
* Acute toxicities (except for alopecia and CTCAE grade 2 neuropathy) of prior treatments and procedures not resolved to CTCAE <= grade 1 or baseline before the first drug administration
* Febrile neutropenia of Common Terminology Criteria for Adverse Events (CTCAE) >= 3
* History of other malignancy within the previous 5 years except a basal cell carcinoma of skin and any other cancer for which treatment has been completed >= 5 years ago and from which the patient has been disease-free5 years ago and from which the patient has been disease-free
* Prior treatment within 4 weeks before the first drug administration with immunotherapy, antiandrogen, CYP17 inhibitor (CYP17i), oral ketoconazole, estrogens, 5-α reductase inhibitors or investigational treatment
* Use of bicalutamide or nilutamide (not approved in Japan) within 6 weeks before the first drug administration
* Radiation therapy (external beam radiation therapy [EBRT], brachytherapy, or radiopharmaceuticals) or chemotherapy (except for nitrosoureas and mitomycin C) within 4 weeks before the first drug administration. Use of nitrosoureas or mitomycin C within 6 weeks before the first drug administration.
* Prior use of any herbal products known to decrease PSA levels (e.g. PC SPES or saw palmetto) within 4 weeks before the first drug administration
|
NCT_ID
NCT02363855
|
Study_NamePhase 1 Dose Escalation Study of BAY 1841788 in Japanese Metastatic Castration-resistant Prostate Cancer (mCRPC) Subjects
| 13,403 |
Study Objectives
The purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging in a previously cleared field.
Conditions: Actinic Keratosis
Intervention / Treatment:
DRUG: Ingenol mebutate gel, 0.015%, DRUG: Vehicle gel
Location: Germany, United Kingdom, Australia, Canada, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Subjects must provide informed consent
* Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on the face or scalp
* Subject at least 18 years
* Female subjects must be of either:
* Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
* Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to study treatment, to rule out pregnancy
* Female subjects of childbearing potential must be willing to consent to using highly effective methods of contraception
Exclusion Criteria:
* Location of the selected treatment area:
* on any location other than the face or scalp
* on the periorbital skin
* within 5 cm of an incompletely healed wound
* within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
* Prior treatment with ingenol mebutate gel on face or scalp (previous treatment on trunk and extremities acceptable)
* Selected treatment area lesions that have atypical clinical appearance
* History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area
* Anticipated need for hospitalization or out-patient surgery prior to Day 15 in the first treatment cycle
* Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel
* Presence of sunburn within the selected treatment area
* Current enrollment or participation in a clinical trial within 30 days of entry into this study
* Subjects previously entered first treatment in the trial
* Female subjects who are breastfeeding
* Subjects who are institutionalised by court order or by the local authority
* In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol
Prohibited Therapies and/or Medications within 2 weeks prior to Day 1
* Cosmetic or therapeutic procedures within 2 cm of the selected treatment area
* Use of keratolytic topical therapeutic products within 2 cm of the selected treatment area
* Use of topical medicated creams, ointments, lotions gels, foams or sprays within 2 cm of the selected treatment area; artificial tanners: within 5 cm of the selected treatment area
Prohibited Therapies and/or Medications: within 4 weeks prior to Day 1
* Treatment with immunomodulators, cytotoxic drugs or interferon /interferon inducers
* Treatment with systemic medications that suppress the immune system
* Treatment/therapy with ultraviolet light A (UVA) or ultraviolet light B (UVB)
Prohibited Therapies and/or Medications within 8 weeks prior to Day 1
* Treatment with 5-fluorouracil (5-FU), imiquimod, diclofenac sodium, or photodynamic therapy: within 2 cm of the selected treatment area
Prohibited Therapies and/or Medications within 6 months prior to Day 1
* Use of systemic retinoids or biologic/monoclonal antibody therapies
|
NCT_ID
NCT01600014
|
Study_NameIngenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp
| 10,893 |
Study Objectives
The purpose of the study is to evaluate the efficacy of the triplet of ridaforolimus, dalotuzumab and exemestane compared to the combination of ridaforolimus and exemestane in post-menopausal participants with breast cancer. The primary hypothesis of the study is that the triplet of ridaforolimus, dalotuzumab and exemestane will improve progression free survival (PFS) compared to ridaforolimus and exemestane.
Conditions: Breast Neoplasms
Intervention / Treatment:
DRUG: Ridaforolimus, DRUG: Dalotuzumab, DRUG: Exemestane
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Females with a histologically confirmed diagnosis of breast cancer that is metastatic or locally advanced (locally advanced tumors must not be amenable to
surgery or radiation therapy with curative intent) with the following pathological characteristics determined locally: estrogen receptor positive and Human Epidermal Growth Factor Receptor 2 (HER-2) negative, and Ki67 (a tumor marker) >= 15% determined by the central study laboratory
* Post-menopausal
* With advanced breast cancer whose disease was refractory to previous letrozole or anastrozole
* Has at least one confirmed measurable metastatic lesion
* Has a performance status <= 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
* Has a life expectancy of at least 3 months
* Adequate organ function
Exclusion Criteria:
* Is receiving any other concurrent systemic tumor therapy, including
hormonal agents and HER-2 inhibitors
* Previously received rapamycin or rapamycin analogs, including
ridaforolimus, temsirolimus, or everolimus
* Received prior treatment with Insulin-like Growth Factor 1 Receptor (IGF-1R) inhibitors, Phosphatidylinositol 3-Kinase (PI3K) inhibitors, or
other experimental agents that target PI3K, Protein Kinase B (AKT), or Mammalian Target of Rapamycin (mTOR) pathway
* Is receiving chronic corticosteroids administered at doses greater than
those used for normal replacement therapy
* Has active brain metastasis or leptomeningeal carcinomatosis; patients
with adequately treated brain metastases are eligible if they meet certain criteria
* Known allergy to macrolide antibiotics
* Has an active infection requiring antibiotics
* Significant or uncontrolled cardiovascular disease
* Poorly controlled Type 1 or 2 diabetes
* Is known to be Human Immunodeficiency Virus (HIV) positive
* Has a known history of active hepatitis B or C. Healthy carriers of hepatitis B are not allowed on this study
|
NCT_ID
NCT01605396
|
Study_NameA Phase II Trial of Ridaforolimus and Exemestane, Compared to Ridaforolimus, Dalotuzumab and Exemestane in Participants With Breast Cancer (MK-8669-064)
| 4,495 |
Study Objectives
The purpose of this study is to determine the maximum tolerated dose of veliparib (ABT-888)and to establish the recommended Phase 2 dose of veliparib (ABT-888) when administered in combination with carboplatin and gemcitabine in subjects with advanced solid tumors.
Conditions: Advanced Solid Tumors
Intervention / Treatment:
DRUG: veliparib (ABT-888), DRUG: carboplatin, DRUG: gemcitabine
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histologically or cytologically confirmed solid tumors that are metastatic or unrespectable for which carboplatin/gemcitabine is a treatment option.
* Eastern Cooperative Group performance score of 0 to 2.
* Adequate hematologic, hepatic and renal function
* Subject has received up to 2 DNA damaging or cytotoxic regimens in the past five years
Exclusion Criteria:
* Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy within 28 days prior to study administration.
* Subjects with known history of brain metastases and primary CNS tumors.
* Hypersensitivity reactions to platinum compounds or gemcitabine.
* Clinically significant and uncontrolled major medical conditions
* Active malignancy within the past 5 years except for any cancer in situ cured or non-melanoma carcinoma of the skin.
|
NCT_ID
NCT01063816
|
Study_NameA Study of ABT-888 in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors
| 8,173 |
Study Objectives
Phase I trial to study the effectiveness of combining oblimersen with cytarabine and daunorubicin in treating older patients who have previously untreated acute myeloid leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may help cytarabine and daunorubicin kill more cancer cells by making them more sensitive to chemotherapy.
Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
Intervention / Treatment:
BIOLOGICAL: oblimersen sodium, DRUG: cytarabine, DRUG: daunorubicin hydrochloride, OTHER: laboratory biomarker analysis, OTHER: pharmacological study
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histologically confirmed primary or secondary acute myeloid leukemia (AML)
* More than 20% bone marrow blasts
* Myelodysplastic syndromes (MDS) or a chronic myeloproliferative disorder antecedent to AML allowed
* Therapy-related AML allowed
* No acute promyelocytic leukemia
* At least 4 weeks
* Bilirubin no greater than 2 mg/dL
* ALT and AST no greater than 2 times upper limit of normal (unless directly attributable to AML)
* Creatinine no greater than 2.5 mg/dL
* Ejection fraction at least 50% by MUGA or echocardiogram
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No allergy to any of the study medications
* No other uncontrolled concurrent illness
* No serious medical or psychiatric illness that would preclude giving informed consent
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior therapy for primary AML except emergency leukapheresis
* No prior anthracyclines
* No prior chemotherapy for primary AML except hydroxyurea for hyperleukocytosis
* At least 3 months since prior chemotherapy for MDS or chronic myeloproliferative disorders antecedent to AML
* No other concurrent chemotherapy
* No concurrent corticosteroids as anti-emetics
* No concurrent steroids except for adrenal failure or septic shock
* No concurrent hormonal therapy except hormones for non-disease-related conditions (e.g., insulin for diabetes, tamoxifen or equivalent for breast cancer prevention or adjuvant treatment, or estrogens or progestins for gynecologic indications)
* No prior radiotherapy for primary AML except cranial radiotherapy for CNS leukostasis
* No concurrent palliative radiotherapy
* No concurrent whole brain radiotherapy
* No other concurrent investigational or commercial agents or therapies
* No concurrent cyclooxygenase-2 inhibitors
|
NCT_ID
NCT00039117
|
Study_NameOblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia
| 6,655 |
Study Objectives
Radiation proctitis is quite common in treatment of pelvic tumors. We investigated whether the use of symbiotic would prevent early symptoms of radiation proctitis and improve the quality of life in patients undergoing radiotherapy for prostate cancer treatment. We randomized patients to intake one sachet of either a symbiotic product containing 4.3 g of dietary fiber and Lactobacillus reuteri in a concentration greater than 10(8)colony forming units (CFU)(Fibermais Flora Nestlé Brazil) or sachets containing 5 g of maltodextrin. They were instructed to dilute one sachet in 200mL of water and drink once a day during the week before the beginning of radiotherapy sessions, and increase the dose to two sachets daily after the beginning of the sessions for four weeks. Every week a questionnaire named EORTC QLQ-PRT23 was applied to evaluate GI symptoms and quality of life.
Conditions: Radiation Proctitis, Prostate Cancer
Intervention / Treatment:
DIETARY_SUPPLEMENT: Symbiotic, DIETARY_SUPPLEMENT: Maltodextrin
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Patients undergoing radiotherapy due to prostate cancer
Exclusion Criteria:
* refuse to participate, previous rectal condition or surgery, inflammatory bowel disease
|
NCT_ID
NCT01901042
|
Study_NameEfficacy of Symbiotic in the Reduction of Acute Radiation Proctitis Symptoms
| 12,039 |
Study Objectives
The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and PLD chemotherapy regimen in patients with platinum-resistant recurrent high grade serous ovarian cancer (HGSOC) with mutated TP53. In addition, the study aims to assess the safety profile of the combined APR-246 and PLD chemotherapy regimen, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll at least 25 evaluable patients.
Conditions: High-grade Serous Ovarian Cancer
Intervention / Treatment:
DRUG: APR-246, DRUG: Pegylated Liposomal Doxorubicin Hydrochloride (PLD)
Location: Belgium, United Kingdom, Spain
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Confirmed High Grade Serous Ovarian Cancer, and positive nuclear immunohistochemical (IHC) staining for p53
* Disease Progression between 4 weeks - 6 months after the last platinum-based treatment was administered
* At least a single measurable lesion
* Adequate organ function prior to registration
* Toxicities from previous cancer therapies (excluding alopecia) must have recovered to grade 1 (defined by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.0). Chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis
* ECOG performance status of 0 to 2
Exclusion Criteria:
* Prior exposure to cumulative doses of doxorubicin >400 mg/m2 or epirubicin >720 mg/m2
* Hypersensitivity to PLD or to any of the excipients
* Unable to undergo imaging by either CT scan or MRI
* Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications
* Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ)
* Is taking concurrent (or within 4 weeks prior to registration) chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation). Supportive care measures are allowed. Palliative limited radiation therapy for pain reduction is allowed
|
NCT_ID
NCT03268382
|
Study_Namep53 Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Study of PLD With APR-246
| 2,368 |
Study Objectives
The purpose of this study is to evaluate the effectiveness and safety of single agent pazopanib in subjects with unresectable or metastatic liposarcoma.
Conditions: Liposarcoma, Surgically Unresectable Liposarcoma, Metastatic Liposarcoma
Intervention / Treatment:
DRUG: pazopanib
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Written informed consent.
* Age > or = to 18 years.
* Histologically or cytologically confirmed high- or intermediate-grade liposarcoma (allowed subtypes include liposarcoma dedifferentiated, myxoid/round cell, pleomorphic, mixed-type, or not otherwise specified).
* Surgically unresectable or metastatic disease.
* Any number of prior treatment treatment regimens, including treatment naive subjects.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Measurable or evaluable (non-measurable) disease per RECIST guidelines version 1.1. Subjects must have documented disease progression within the past 6 months.
* Adequate organ system function determined within 14 days prior to first dose of study treatment.
* Left ventricular ejection fraction (LVEF) > 50% of the institutional LLN within 28 days prior to the first dose of study treatment.
* Females must be of either non-child bearing potential or have a negative pregnancy test within 7 days prior to the first dose of study treatment.
Exclusion Criteria:
* Well differentiated liposarcoma.
* Prior treatment with tyrosine kinase inhibitors (TKIs) or vascular endothelial growth factor (VEGF) inhibitors.
* Prior malignancy (Note: subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible).
* History or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis, unless previously treated, asymptomatic, and off steroids and anti-seizure medication for 6 months prior to first dose of study drug
* Clinically significant gastrointestinal (GI) abnormalities that may increase the risk for GI bleeding.
* Clinically significant GI abnormalities that may affect absorption of investigational product.
* Presence of uncontrolled infection.
* Corrected QT interval > 480 msecs using Bazett's formula.
* History of certain cardiovascular conditions within the past 6 months.
* Poorly controlled hypertension [defined as systolic blood pressure of > or = 140 mmHg or diastolic blood pressure > or = 90 mmHg].
* History of cerebrovascular accident including transient ischemic attack, pulmonary embolism, or untreated deep vein thrombosis within the past 6 months.
* Prior major surgery or trauma within 28 days prior to the first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
* Evidence of active bleeding or bleeding diathesis.
* Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage.
* Hemoptysis in excess of 2.5 mL within 8 weeks of first dose of study drug.
* Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
* Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug, whichever is longer, prior to the first dose of study drug and for the duration of study treatment.
* Radiation therapy, minor surgery, tumor embolization, chemotherapy, immunotherapy, biologic therapy, investigational therapy, or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug.
* Administration of any non-oncologic investigational drug within 30 days or five half-lives (whichever is longer) prior to receiving the first dose of study drug.
* Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity, except alopecia.
* Known immediate or delayed hypersensitivity reaction to idiosyncrasy to drugs chemically realted to pazopanib or excipients that contraindicates participation.
|
NCT_ID
NCT01506596
|
Study_NameStudy of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Liposarcoma
| 4,780 |
Study Objectives
The primary objective of this study is to evaluate the efficacy and safety of veliparib and whole brain radiation therapy in adults with brain metastases from non-small cell lung cancer (NSCLC).
Conditions: Brain Metastases From Non-small Cell Lung Cancer
Intervention / Treatment:
DRUG: Veliparib, DRUG: Placebo, RADIATION: Whole brain radiation therapy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Subject must have cytologically or histologically confirmed non-small cell lung cancer
* Subject must have brain metastases demonstrated on a magnetic resonance imaging (MRI) brain scan.
* Subject must be eligible for treatment with WBRT
* Subject must have had adequate hematologic, renal, and hepatic function.
Exclusion Criteria:
* Subject is diagnosed with brain metastases greater than 28 days prior to Day 1
* Subject received any prior form of cranial radiation and/or neurosurgery for their brain metastases
* Subject's last dose of anti-cancer therapy or investigational therapy was less than or equal to 7 days prior to Day 1
* Subject has a Karnofsky Performance Score of less than 70
* Subject has significant dyspnea requiring supplemental oxygen therapy
* Subject has liver metastases (restaging is not required for known liver metastases)
* Subject has more than 2 sites (organ systems) of metastases from non-small cell lung cancer with the exception of intra-cranial sites of metastases from non-small cell lung cancer, thoracic sites of metastases from non-small cell lung cancer and bone metastases
* Subject has leptomeningeal metastases or subarachnoid spread of tumor
* Subject has unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment
* Subject has a known seizure disorder that is uncontrolled, or has seizures occurring greater than or equal to 3 times a week over the past month. Subjects presenting with symptoms of seizures from the brain metastases are eligible; however he/she should receive adequate anti-seizure medication prior to study treatment
* Subject is pregnant or lactating
* Subject has previously been treated with a poly-(ADP-ribose)-polymerase inhibitor as an investigational agent
* Subject has clinically significant and uncontrolled major medical condition(s)
* Subject has a history of another active cancer within the past 5 years except: cervical cancer in situ, in situ carcinoma of the bladder, basal or squamous cell carcinoma of the skin or other cancer in situ that is considered cured
|
NCT_ID
NCT01657799
|
Study_NameComparison of Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Adults With Brain Metastases From Non-Small Cell Lung Cancer
| 12,323 |
Study Objectives
In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used since the 1960s and is regarded as the standard of care in elderly patients. We assess whether the addition of thalidomide to this combination or adapted high-dose chemotherapy, using a melphalan 100 mg/m2 -based regimen, would improve survival.
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Thalidomide
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Stage II or III multiple myeloma according to Durie and Salmon criteria.
* Patients between 65 and 75 years
* Previously untreated patients
Exclusion Criteria:
* Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma)
* Primary or associated amyloidosis
* World Health organisation performance index of at least 3
* Significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more
* Cardiac or hepatic dysfunction
* Cerebral circulatory insufficiency
* Absolute contraindication to corticosteroids
* Peripheral neuropathy
* HIV or hepatitis B or C positivity
* Patients who had geographic, social or psychological conditions which might prevent adequate follow-up
|
NCT_ID
NCT00367185
|
Study_NameTreatment of Newly Diagnosed Elderly Patients With Multiple Myeloma
| 19,334 |
Study Objectives
IO-002 study is a multicenter, open-label, dose-escalation Phase I/IIa clinical study to evaluate the safety and tolerability, PK, PD, and antitumor activity of EOS884448 in participants with advanced cancers.
Conditions: Advanced Cancer
Intervention / Treatment:
DRUG: EOS884448
Location: Belgium
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SEQUENTIAL
Masking: NONE
|
Inclusion Criteria:
* Be willing to provide a signed written informed consent for the trial and consent for biopsies before and during administration of EOS884448
* Be more than18 years on day of signing informed consent.
* Have histologically or cytologically confirmed advanced or metastatic cancer for whom no standard treatment is further available
* Have evaluable disease, per RECIST v1.1 for solid tumor escalation or other criteria if indicated
* Have an ECOG performance status of Grade 0 to 1.
* Have adequate organ function.
* Agree to use adequate contraception during the treatment if required.
Exclusion Criteria:
* Has received any anti-cancer therapy, unless at least 4 weeks (or 5 half-lives, whichever is shorter) since the last dose.
* Has undergone major surgery within 5 weeks before initiating treatment.
* Has received prior radiotherapy within 2 weeks of start of IP.
* Has toxicity (except for alopecia) related to prior anti-cancer therapy, unless the toxicity is resolved, returned to baseline or Grade 1, or deemed irreversible.
* Has known CNS metastases.
* Has any condition requiring concurrent use of systemic immunosuppressants or corticosteroids.
* Has uncontrolled or significant cardiovascular disease.
* Has received vaccine containing live virus within 4 weeks.
* Has known active or chronic viral hepatitis.
* Has any known or underlying medical, psychiatric condition, and/or social situations that, in the opinion of the investigator, would limit compliance with study requirements.
|
NCT_ID
NCT04335253
|
Study_NameFirst-In-Human Study of EOS884448 in Participants With Advanced Cancers.
| 22,009 |
Study Objectives
The purpose of this study is to determine whether Amplimexon (imexon for injection) is effective in the treatment of indolent and aggressive lymphomas that have progressed after treatment with standard therapies.
Conditions: Follicular Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma, Lymphoplasmacytic Lymphoma, Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma, Burkitt's Lymphoma
Intervention / Treatment:
DRUG: Imexon
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Diagnosis:
Group 1: Histologically confirmed indolent NHL, including follicular (any grade), small lymphocytic lymphoma, marginal zone lymphoma and lymphoplasmacytic lymphomaGroup 2: histologically confirmed diffuse large B-cell, mantle cell, Burkitt, Burkitt-like, and diffuse large B-cell transformed from indolent non-Hodgkin's lymphoma.
* Prior treatment:
Group 1: (indolent histologies): Patients must have demonstrated relapsed or refractory disease to 1 prior treatment regimen. The maximum number of prior regimens used for treatment is not specified.
Group 2: (aggressive histologies): Patients must have demonstrated relapsed or refractory disease to at least 1 prior treatment regimen. In the case of de novo diffuse large B-cell lymphoma, prior treatment must include R-CHOP or R-CHOP-like therapy, as well as second line autologous stem cell transplantation unless the patient is not eligible. The maximum number of prior regimens is not specified.
* At least one target lesion, measurable by radiographic methods according to the 2007 Revised Response Criteria for Malignant Lymphoma.
* ECOG Performance Status 0 <= age <= 2.
* No clinical or laboratory evidence of central nervous system disease.
* Adult (age >= 18 years).
* Projected life expectancy >4 months.
* If female, neither pregnant (negative pregnancy test required at screening) nor lactating.
* If of child-bearing potential, must be able to use and agree to use medically acceptable contraception for the duration of the study. For female subjects who are neither post-menopausal nor surgically sterilized, this includes oral or injectable hormonal methods, barrier methods such as an intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence. Male subjects must also agree to use an acceptable method for contraception for the duration of the study.
* No major infection or serious uncontrolled concomitant disease. Fully recovered from any major surgery.
* No evidence of other concurrent active malignancy.
* At least 4 weeks since any prior cancer chemotherapy (2 weeks for corticosteroids), antibody therapy, or radiotherapy.
* Prior radiotherapy to less than an estimated 25% of the bone marrow. In addition, the target lesion(s) must not have been previously irradiated.
* Clinical laboratory values within the following limits:
1. Hgb >=10.0 g/dL
2. Absolute neutrophil count ANC >=1,500/mm3
3. Platelets >=75,000/mm3
4. Serum creatinine <=2.0 times upper limit of normal
5. Serum bilirubin <=2.0 times upper limit of normal
6. Serum AST and ALT <=3 times upper limit of normal
* G6PD level >= lower limit of normal
* Able and willing to render informed consent and to follow protocol requirements.
Exclusion Criteria:
* Diagnosis of lymphoma based on fine needle aspirate.
* Curative therapy is indicated or possible.
* Absence of a measurable target lesion, or the only target lesion was previously irradiated.
* Symptoms, exam findings, or laboratory findings to suggest central nervous system disease involvement.
* Age < 18 years
* Projected life expectancy <4 months.
* Pregnant or lactating.
* Unable or unwilling to use medically acceptable contraception, if of childbearing potential.
* Evidence of major infection or other serious uncontrolled concomitant illness. Not fully recovered from prior major surgery.
* Evidence of other active malignancy.
* Prior radiotherapy, antibody therapy, or cancer chemotherapy within 4 weeks before start of treatment (2 weeks for corticosteroids). Prior radiotherapy to >25% of the bone marrow.
* Clinical laboratory values outside of permitted ranges.
* Respiratory insufficiency requiring oxygen therapy; angina at rest, or myocardial infarction in previous 3 months; history of life threatening ventricular arrhythmia; uncompensated CHF or NYHA Grade 3 or 4 cardiac disease.
* Unable or unwilling to give informed consent and to follow protocol requirements.
* Failure to meet any of the eligibility criteria.
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NCT_ID
NCT01314014
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Study_NameImexon for Relapsed Follicular and Aggressive Lymphomas
| 8,716 |
Study Objectives
The purpose of this study is to assess rheumatologic tolerability of letrozole in postmenopausal patients with hormone receptor positive breast cancer having discontinued anastrozole adjuvant treatment due to musculoskeletal disorders.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Letrozole
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Postmenopausal women receiving anastrozole adjuvant therapy for hormone receptor positive breast cancer who want to interrupt the treatment because of severe rheumatologic adverse events
* Polymorphonuclear neutrophils (PNN) >= 1200/mm3, platelets >= 100000/mm3, hemoglobin (Hb) >= 10 g/dL
* Bilirubin <= 30 μmol, SGOT/SGPT < 3N
* Fully signed informed consent
Exclusion Criteria:
* Pain due to bone fracture
* Metastatic disease
* Hormone therapy other than anastrozole
* Incapacitating or uncontrolled concomitant disease that could hamper patient's quality of life
* Hypersensitivity to letrozole or its components
Other protocol-defined inclusion/exclusion criteria may apply.
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NCT_ID
NCT00329940
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Study_NameSafety and Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer
| 10,647 |
Study Objectives
5-ALA and the Orbeye surgical microscope are U.S. Food and Drug Administration (FDA) approved products. For this study, the Orbeye microscope imaging system is being used with special filters to visualize 5-ALA fluorescence. The FDA currently permits the use of these filters. The purpose of this study is to collect medical information before, during, and after standard treatment in order to better understand how to make this type of procedure accessible to patients.
This study is also being conducted to determine if use of the Orbeye equipped with these special filters improves the ability of the surgeon to remove brain tumors.
Conditions: Brain Tumor, Glioma
Intervention / Treatment:
DEVICE: Orbeye surgical videomicroscope, DRUG: 5-Aminolevulinic Acid
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
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Inclusion Criteria:
* Must have a suspected or biopsy-proven high-grade glioma (World Health Organization grade II or IV), new or recurrent.
* Indication for craniotomy for removal of a suspected or recurrent brain tumor
* Karnofsky Performance Scale >/- 60%
Exclusion Criteria:
* Prophyria, hypersensitivity to porphyrins
* Renal insufficiency as defined per protocol
* Hepatic insufficiency as defined per protocol
* Existing pregnancy (to be checked by a pregnancy test if of child-bearing age.
* Nursing women or women using inadequate contraception
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NCT_ID
NCT04055688
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Study_NameNovel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas
| 18,225 |
Study Objectives
A Multi-Center, Open-label Phase Ib-II Trial of the Combination of GX-188E Vaccination and Pembrolizumab in Patients with Advanced, Non-Resectable HPV-Positive Cervical Cancer
Conditions: Cervical Cancer
Intervention / Treatment:
DRUG: GX-188E, DRUG: KEYTRUDA®
Location: Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients must be female and age >= 18 years (19 years for Korean sites)
* Patients with histologically confirmed advanced or metastatic HPV-positive (HPV-16 or HPV-18) cervical cancer, who have disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 <= age <= 1
* Life Expectancy of at least 6 months
* Patients must agree to provide either an archival tumor tissue sample or fresh biopsy sample for baseline biomarker tissue analyses, including staining for PD-L1. If archival tissue is not available and the patient does not have biopsy-accessible tumor lesions, the patient will be excluded.
Exclusion Criteria:
* Patient has disease that is suitable for local therapy administered with curative intent.
* Patient has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Patient is expected to require any other form of antineoplastic therapy while on study; including systemic chemotherapy, radiation therapy (except for palliative purposes) biological therapy, or immunotherapy not specified in this protocol.
* Patient has a history of active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Patients have received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher immune-related Adverse Event (irAE)
* Patients with active autoimmune disease requiring systemic immunosuppressive treatment within the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
* Patients has had an allogeneic solid organ or allogeneic bone marrow transplant
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NCT_ID
NCT03444376
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Study_NameThe Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer
| 5,986 |
Study Objectives
This phase I/II trial studies the side effects and best dose of melphalan hydrochloride in treating participants with newly-diagnosed multiple myeloma who are undergoing a donor stem cell transplantation. Giving chemotherapy before a donor stem cell transplantation helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the participant, they may help the participant's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving melphalan hydrochloride before a donor stem cell transplantation may work better than standard chemotherapy in helping to prevent multiple myeloma from coming back.
Conditions: Plasma Cell Myeloma
Intervention / Treatment:
PROCEDURE: Autologous Hematopoietic Stem Cell Transplantation, BIOLOGICAL: Filgrastim-sndz, DRUG: Melphalan Hydrochloride
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria:
* Patients with non-relapsed multiple myeloma in complete response (CR), partial remission (PR), very good partial remission (VGPR), or symptomatic stable disease (no evidence of progression) including patients with light chain multiple myeloma (MM) detected in the serum by free light chain assay OR
* Patients with non-secretory multiple myeloma (absence of a monoclonal protein [M protein] in serum as measured by electrophoresis [serum protein electrophoresis (SPEP)] and immunofixation (serum immunofixation electrophoresis [SIFE]) and the absence of Bence Jones protein in the urine [urine protein electrophoresis (UPEP)] defined by use of conventional electrophoresis and immunofixation [urine immunofixation electrophoresis (UIFE) techniques]) but with measurable disease on imaging studies like magnetic resonance imaging (MRI), computed tomography (CT) scan or positron emission tomography (PET) scan.
* Patients who have received at least two cycles of initial systemic therapy and are within 2 to 12 months of the first dose. Mobilization therapy is not considered initial therapy.
* Karnofsky performance score 70% or higher.
* Left ventricular ejection fraction at rest > 40% within 3 months of registration.
* Bilirubin < 2 x the upper limit of normal (except patients with Gilbert syndrome in whom bilirubin level of > 2 x upper normal limit will be allowed)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x the upper limit of normal.
* Creatinine clearance of >= 40 mL/min, estimated or calculated using the Cockcroft-Gault equation.
* Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), forced vital capacity (FVC) > 50% of predicted value (corrected for hemoglobin) within 3 months of registration.
* All female and male subjects of reproductive potential must consent to the use of effective contraceptive methods as advised by the study doctor during treatment.
* Signed informed consent form.
Exclusion Criteria:
* Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
* Patients seropositive for the human immunodeficiency virus (HIV).
* Patients with history of myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
* Patients participating in an investigational new drug protocol within 14 days before enrollment.
* Female patients who are pregnant (positive beta-human chorionic gonadotropin [b-HCG]) or breast feeding.
* Prior hematopoietic cell transplantation allogeneic or autologous (A prior autologous HCT will be allowed as long as it was part of tandem transplantation).
* Prior organ transplant requiring immunosuppressive therapy
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NCT_ID
NCT03417284
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Study_NameMelphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation
| 16,921 |
Study Objectives
Phase 2B, multicenter study evaluating the safety and efficacy of weekly TOCOSOL Paclitaxel in taxane-naive patients receiving second line chemotherapy for metastatic or locally advanced, unresectable transitional cell carcinoma of the urothelium
Conditions: Bladder Neoplasms, Ureteral Neoplasms, Urethral Neoplasms, Carcinoma, Transitional Cell
Intervention / Treatment:
DRUG: TOCOSOL Paclitaxel
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Histologic diagnosis of transitional cell carcinoma (TCC) of the urothelium including bladder, renal pelvis, ureter, or urethra
* Stage IV disease
* One and only one prior systemic cytotoxic chemotherapy regimen administered as adjuvant or neoadjuvant chemotherapy or to treat locally advanced or metastatic disease
* Adequate hematologic function (ANC >= 1500 cells/mm3 & platelet count >= 100,000/mm3)
* Serum creatinine <= 2.0 mg/dL
* Total bilirubin <= 1.5 mg/dL
* SGOT & SGPT <= 3 times upper limit of institutional normal values
* PT (INR) & PTT within institutional lab normal range
* Karnofsky performance status of 60 <= age <= 100%
* At least one unidimensionally measurable lesion, suitable for radiographic evaluation of disease response, consistent with RECIST criteria
* Signed IRB/EC approved Informed Consent
* Life expectancy of at least 12 weeks
* 18 years or older
* Fully recovered from any previous surgery
* Not pregnant and willing to use a medically effective form of contraception during periods of chemotherapy treatment (both males and and females)
* Agree not to take vitamin E supplementation while receiving study medication
* Willing to participate in requested follow-up evaluations
* Willing to permit treating physicians to provide information to Sonus regarding disease status and survival for 2 years after first dose of study drug
Exclusion Criteria:
* Prior taxane-containing chemotherapy including Taxol(R) (paclitaxel) or generic equivalent, or Taxotere(R) (docetaxel)
* Peripheral neuropathy NCI-CTC grade 2 or greater
* Wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of first dose, or mitomycin or nitrosoureas within 6 weeks of first dose, of study drug
* An investigational agent within 4 weeks of first dose of study drug
* Concurrent anticonvulsants known to induce P450 isoenzymes
* Patients who are pregnant or lactating
* A history of carcinoma of another primary site (other than non-melanoma skin cancers or carcinoma-in-situ of the cervix) within the previous 5 years, unless metastatic disease has been biopsied and documented to be TCC
* Bone metastasis, effusions, ascites or elevated tumor markers as the only evidence of metastatic TCC
* Brain metastasis
* Active bowel obstruction
* Active, serious infection or other serious medical problems (other than TCC) likely to impair completion of the study protocol
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NCT_ID
NCT00077688
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Study_NameTOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium
| 19,190 |
Study Objectives
This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection.
Conditions: HSIL, High-Grade Squamous Intraepithelial Lesions, Human Papilloma Virus Infection, HIV Infection, Anal Cancer, Anus Neoplasms
Intervention / Treatment:
DRUG: ABI-1968
Location: United States, Australia
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE
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Inclusion Criteria:
* Female or male subjects, at least 27 years.
* Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining)
* Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer.
* For HIV-positive subjects, CD4 count must be at least 200/mm3 with undetectable (<50 copies/mL) viral load within the 3 months prior to enrollment. Subjects must be on a stable regimen of antiretroviral drugs for the 3 months prior to enrollment.
Exclusion Criteria:
* Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females.
* Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment.
* History of cancer, including anal cancer (with the exception of basal cell or squamous cell carcinoma of the skin), or currently undergoing treatment for any skin cancer.
* History of genital herpes with > 3 outbreaks per year.
* Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.
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NCT_ID
NCT03202992
|
Study_NameStudy of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection
| 5,801 |
Study Objectives
The purpose of this study is to investigate the activity of SU011248 in subjects with cisplatin-refractory or multiply relapsed germ cell cancer. It is believed that SU011248 treatment may prove to increase disease response.
Conditions: Relapsed or Cisplatin-Refractory Germ Cell Cancer
Intervention / Treatment:
DRUG: SU011248 (Sunitinib)
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* patients with histologically proven seminomatous or non-seminomatous germ cell cancer
* patients with relapse within 8 weeks after at least 2 different cisplatin- based regimens or
* patients with disease progression or relapse after salvage high-dose chemotherapy or patients with disease progression during cisplatin-based chemotherapy or patients with contraindications for other aggressive chemotherapy
* measurable disease
* Life expectancy of greater than 3 months
* Karnofsky Performance status > 60
* > 1 years
* adequate organ function
* Resolution of acute toxic effects of prior radiotherapy, surgical procedure or chemotherapy to NCI CTCAE Version 3.0 <= grade 1.
* Left ventricular ejection fraction (LVEF) >= lower limit of normal (LLN) as defined by the institution performing the scan as assessed by multigated acquisition (MUGA) scan or echocardiography
* Signed and dated informed consent document
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion Criteria:
* Acute infection
* Uncontrolled intercurrent illness
* Patients with a history of other active malignancy in the past 5 years (with the exception of adequately treated cervical carcinoma in situ and non melanomatous skin cancers) are excluded.
* Interval from last chemotherapy < 3 weeks.
* Simultaneous radiation of the only target lesion
* NCI CTCAE grade 3 hemorrhage < 4 weeks of starting the study treatment
* Patients must not be on therapeutic anticoagulation.
* Major surgery or radiation therapy within < 4 weeks of starting the study treatment.
* History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease
* Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
* Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
* Ongoing cardiac arrhythmias of NCI CTCAE grade >= 2, atrial fibrillation of any grade, or prolongation of the QTc interval to >500 msec on baseline EKG.
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
* Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy).
* Current treatment on another clinical trial.
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NCT_ID
NCT00371553
|
Study_NamePhase-II Study of SU011248 (Sunitinib)in Male Patients With Relapsed or Cisplatin-Refractory Germ Cell Cancer
| 21,980 |
Study Objectives
The main purpose of this study is to determine the recommended doses of selinexor in combination with liposomal doxorubicin and dexamethasone for patients with relapsed and refractory myeloma. In addition, the study will assess whether this combination with effective for patients with multiple myeloma.
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Selinexor, DRUG: Liposomal doxorubicin, DRUG: Dexamethasone
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients with relapsed and refractory multiple myeloma who have received at least 2 prior therapies which must include lenalidomide and a proteasome inhibitor. Patients must have disease refractory to the most recent therapy. Refractory myeloma is defined as progressive disease during or within 60 days of last therapy. Patients must have previously received or be ineligible for (or refused) autologous stem cell transplant.
* Must have measurable myeloma paraprotein levels in serum (>= 0.5 g/dL) or urine (>= 0.2 g excreted in a 24-hour urine collection sample) or by free light chain (involved free light chain greater than 100 mg/L).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 <= age <= 1. ECOG 2 allowed if due to bone disease
* Must have an echocardiogram or multigated acquisition (MUGA) scan indicating left ventricular ejection fraction (LVEF) >= 50% within 42 days prior to first dose of study drug
* Adequate hematological function
* Adequate hepatic function within 14 days prior to loading phase (day -14)
* Adequate renal function within 14 days prior to loading: estimated creatinine clearance of >= 30 mL/min, (Cockcroft and Gault)
* Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening. Male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose.
Exclusion Criteria:
* Women who are pregnant or lactating
* Radiation, chemotherapy, or immunotherapy or any other approved anticancer therapy <=2 weeks prior to day -7 (beginning of loading phase)
* Major surgery within four weeks before Day -7
* Myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
* Prior cumulative exposure to doxorubicin (including liposomal preparation) > 350mg/m^2
* Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study
* Known to be HIV seropositive
* Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) RNA or HBsAg (HBV surface antigen)
* Any underlying condition that would significantly interfere with the absorption of an oral medication
* Grade >2 peripheral neuropathy at baseline (within 14 days prior to loading phase (day -7))
* Serious psychiatric or medical conditions that could interfere with treatment
* Participation in an investigational anti-cancer study within 3 weeks prior to day -7(beginning of loading phase)
* Concurrent therapy with approved or investigational anticancer therapeutic
* Coagulation problems and active bleeding in the last month
* Previous allogeneic transplant within 6 months and have evidence of clinically significant graft versus host disease
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NCT_ID
NCT02186834
|
Study_NameSelinexor (KPT-330) and Liposomal Doxorubicin For Relapsed and Refractory Multiple Myeloma
| 7,206 |
Study Objectives
This is a progressive dose escalation study designed to evaluate the safety of Hemospan compared to a standard crystalloid solution (Ringer's lactate) in elective surgery patients undergoing total prostatectomy procedures with anticipated blood loss of more than 500 mL. Secondary objectives of this study are to observe possible activity of Hemospan for tissue oxygenation, perfusion and cardiovascular support.
Conditions: Blood Loss, Surgical, Prostate Cancer, Surgery
Intervention / Treatment:
DRUG: Hemospan (MP4OX), DRUG: Ringer's lactate
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: SINGLE
|
Inclusion Criteria:
* Adult male ASA class I or II patients over the age of 18 scheduled for elective total prostatectomy surgery with anticipated blood loss greater than 500 mL
* Patients must be in good health (other than the indication for prostatectomy surgery) as determined by medical history, physical examination, clinical laboratory studies and electrocardiogram (ECG)
* At screening (within 2 weeks of the scheduled surgery) the blood chemistry and hematology (Hb, Hct, RBC, WBC, platelets, PT, PTT, plasma fibrinogen, fibrin split products and haptoglobin) must be within the laboratory normal limits
* Patients must test negative for HIV and hepatitis screens
* Patients must sign an Informed Consent Form (see Appendix II) for the study, which has been reviewed and approved by the Institutional Review Board, prior to screening and entry into the study
* Patients must be available within the continental United States for the period of this study, and willing to complete the follow-up at 4 <= age <= 6 weeks
* Patients must be able to understand and read English
Exclusion Criteria:
* Any acute or chronic condition which would limit the patient's ability to complete the study or jeopardize the safety of the patient
* History or clinical manifestations of a significant cardiovascular or pulmonary disorder
* Clinically significant psychiatric disorder requiring active treatment
* History of diabetes requiring active treatment
* History or clinical manifestation of significant renal or hepatic disorder
* History of thyroid disease or clinical symptoms consistent with thyroid disease
* History of bleeding disorder
* History or family history of a hemoglobinopathy
* Patients with contraindications to TEE probe insertion
* Patients who have received any other investigational drugs within 30 days prior to administration of the study drug
* Professional or ancillary personnel involved with this study
|
NCT_ID
NCT00425334
|
Study_NameSafety Study of Hemospan® in Prostatectomy Patients
| 7,343 |
Study Objectives
In this multicenter trial, we plan to evaluate the feasibility and toxicity of initial treatment with irinotecan/carboplatin/radiation therapy, followed by treatment with bevacizumab, in patients with limited stage small cell lung cancer.
Conditions: Lung Cancer
Intervention / Treatment:
DRUG: Irinotecan, DRUG: Carboplatin, DRUG: Bevacizumab, RADIATION: Radiation
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
To be included in this study, you must meet the following criteria:
* Small cell lung cancer, confirmed by biopsy.
* Limited stage disease after standard evaluation.
* Able to perform activities of daily living without assistance.
* No previous treatment with chemotherapy, radiation therapy, or biologics.
* Measurable or evaluable disease
* Adequate bone marrow, liver and kidney function
* Able to understand the nature of this study and give written consent.
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
* Age < 18 years
* History of previous malignancies
* Women pregnant or lactating
* History or physical exam evidence of central nervous system disease)
* Active infection requiring intravenous antibiotics
* Full-dose anticoagulation or thrombolytic therapy within 10 days
* Proteinuria.
* Serious nonhealing wound, ulcer, or bone fracture
* Evidence if bleeding diathesis or coagulopathy
* History of heart attack within 6 months.
* Uncontrolled cardiovascular disease
* PEG or G-tube
* History of other serious disease
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
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NCT_ID
NCT00193375
|
Study_NameIrinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab in Limited Stage Small Cell Lung Cancer
| 12,533 |
Study Objectives
To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: PF-06863135 monotherapy IV or SC, DRUG: PF-06863135 + dexamethasone, DRUG: PF-06863135 + lenalidomide, DRUG: PF-06863135 + pomalidomide
Location: Canada, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE
|
Inclusion Criteria:
* Relapsed/refractory multiple myeloma
* Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
* Performance Status of 0- 1 ( Performance Score 2 is permitted only if due to underlying myeloma)
* Adequate bone marrow, hematological, kidney and liver function
* Resolved acute effects of any prior therapy to baseline severity
* Not pregnant
Exclusion Criteria:
* Recent history of other malignancies
* History of active autoimmune disorders
* Any form of primary immunodeficiency
* Active and clinically significant bacterial, fungal, or viral infection
* Evidence of active mucosal or internal bleeding
* History of severe immune-mediated adverse event with prior immunomodulatory treatment
* Major surgery within 4 weeks of study treatment start
* Radiation therapy within 2 weeks of study treatment start
* History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment
* Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry
* Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy
* Requirement for systemic immune suppressive medication except as permitted in the protocol
* Current requirement for chronic blood product support
|
NCT_ID
NCT03269136
|
Study_NamePF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma
| 7,560 |
Study Objectives
Drugs used in chemotherapy such as CCI-779 work in different ways to stop cancer cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia in blastic phase
Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Blastic Phase Chronic Myelogenous Leukemia, Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Refractory Anemia With Excess Blasts, Refractory Anemia With Excess Blasts in Transformation, Relapsing Chronic Myelogenous Leukemia, Secondary Myelodysplastic Syndromes
Intervention / Treatment:
DRUG: temsirolimus, OTHER: laboratory biomarker analysis
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Diagnosis of 1 of the following:
* Acute myeloid leukemia
* Acute lymphoblastic leukemia
* Myelodysplastic syndromes
* Refractory anemia with excess blasts [RAEB]
* RAEB in transformation
* Chronic myelomonocytic leukemia in transformation with >= 10% peripheral blood/bone marrow blasts
* Chronic myelogenous leukemia in blastic phase
* Disease status must meet 1 of the following criteria:
* Primary resistant disease (i.e., failed to achieve a complete response [CR] to a prior standard induction regimen)
* Relapsed disease after achieving a CR
* Documented failure to most recent cytotoxic regimen
* No other potentially curative options
* No known CNS disease
* Performance status - ECOG 0 <= age <= 2
* SGOT or SGPT < 3 times upper limit of normal*
* Bilirubin <= 2 mg/dL*
* Creatinine <= 2 mg/dL (unless due to organ leukemic involvement)
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior allergic reaction attributed to compounds of similar chemical or biological composition to CCI-779
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No AIDS-defining disease
* HIV positive allowed if CD4 counts normal
* No other concurrent uncontrolled illness
* No concurrent prophylactic hematopoietic colony-stimulating factors
* More than 2 weeks since prior cytotoxic chemotherapy (except hydroxyurea) and recovered
* More than 2 weeks since prior radiotherapy and recovered
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* No other concurrent anticancer agents or therapies
|
NCT_ID
NCT00084916
|
Study_NameCCI-779 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, or Chronic Myelogenous Leukemia in Blastic Phase
| 8,096 |
Study Objectives
This randomized, multicenter,open-label phase II/III study is to evaluate the effects of chemotherapy combination with autologous cytokine-induced killer Cell immunotherapy in patients with stage IIIb-IV squamous non-small-cell lung cancer
Conditions: Non-small Cell Lung Cancer, Squamous Cell Carcinoma
Intervention / Treatment:
BIOLOGICAL: CIK cell, DRUG: Gemcitabine Injection, DRUG: Cisplatin injection
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Sex: male or female
* Age: from 18 <= age <= 80
* Histology: squamous non-small-cell lung cancer
* Clinical stage: from stage IIIb to stage IV
* Therapy: not received chemotherapy, radiotherapy, or immunotherapy before entry into this study
* Karnofsky performance status: more than 50%
* Expected survival: more than 2 months
* Laboratory tests results 7 days before the start of treatment:
White blood cells: more than 3.0 × 109/L Platelets: more than 100 × 109/L Neutrophils: more than 1.5 × 109/L Hemoglobin: more than 80g/L Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN) Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN Serum bilirubin: less than 1.25 × ULN Serum creatinine: less than 1.25 × ULN
* pregnancy test: the test of women of child-bearing period must be negative 7 days before the start of treatment
* Contraception: male and female subjects of child-bearing period must adopt a reliable method of contraception before entry into this study until 30 days after stopping this study
* Informed consent: subject must have the ability to understand and voluntarily sign a written informed consent
Exclusion Criteria:
* History of neoplasms: other neoplasms
* Medical history: mental disease, or congestive heart failure, or severe coronary artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy
* History of allergies: allergic to the study drugs
* Metastasis: clinical symptoms of brain metastasis
* Other clinical trial: the subject received other clinical trial before this study
* Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus was positive
* Woman: pregnant or lactating women
* Compliance: poor compliance
* History of neoplasms: other neoplasms
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NCT_ID
NCT01631357
|
Study_NameStudy of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy to Treat Lung Cancer
| 784 |
Study Objectives
The purpose of this study is to determine whether the addition of the fully human EGFr antibody zalutumumab to primary curative radiotherapy increases locoregional control in Squamous Cell Carcinomas of the Head and Neck.
Conditions: Cancer of the Head and Neck
Intervention / Treatment:
RADIATION: Radiotherapy, DRUG: Zalutumumab
Location: Denmark
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Histological proven squamous cell carcinoma of the pharynx, larynx (excp. stage 1 larynx and stage 1+2 glottic larynx)
* Curative intent and no prior treatment
* Age > 18 years
* WHO performance 0 <= age <= 2 (incl.)
* No prior treatment with EGFr-I
* Informed consent according to local guidelines and national law
* The patient is able (psychological, sociological, geographical and physical) to carry through the treatment and follow-up
* Fertile women must use contraceptive devices (IUD or oral contraceptives)
Exclusion Criteria:
* Rhinopharynx or carcinomas of unknown origin
* Distal metastases
* Other malignant diseases (prior or current) except from planocellular skin cancer
|
NCT_ID
NCT00496652
|
Study_NameDAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC
| 12,249 |
Study Objectives
The purpose of this pilot phase II trial is to identify the molecular and genetic mechanisms by which statins influence breast cancer cell proliferation. Simvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and reduce the aggressiveness of breast cancer cells.
Conditions: Invasive Breast Carcinoma, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7
Intervention / Treatment:
OTHER: Laboratory Biomarker Analysis, DRUG: Simvastatin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Provision of informed consent prior to any study specific procedures
* Histologic confirmation of invasive breast cancer with any measures of ER, PR and HER2neu
* Clinical stage I or II breast cancer for which there will be at least a 2 week period of time between diagnosis and definitive surgery
* Performance status (Eastern Cooperative Oncology Group [ECOG] 0 <= age <= 1)
* Not currently pregnant during the study; participants will be informed that the use of contraceptive pills is contraindicated because it may interfere with the study drug and it may be harmful to the woman who has been diagnosed with breast cancer
Exclusion Criteria:
* Plans for administration of neoadjuvant chemotherapy or hormonal therapy
* Insufficient tissue on diagnostic core breast biopsy for analysis
* Previous or concurrent malignancy (with the exception of non-melanomatous skin cancer)
* Severe gastrointestinal disorder
* Current use of statins or fibrates for any time during the 3 months prior to the study
* Proven hypersensitivity to statins
* White blood cell (WBC) < 3,500/mm^3
* Platelet (Plt) < 120,000/mm^3
* Hemoglobin (HgB) < 10 g/dL
* Aspartate aminotransferase (AST) > 45 U/L
* Alanine aminotransferase (ALT) > 45 U/L
* Creatinine > 1.5 mg/dL
* Bilirubin > 1.15 mg/dL
* Creatine kinase measurement (CPK) > or = 250 mg/dL
* Central nervous system (CNS) diseases and major psychiatric diseases or inability to comply to the protocol procedures
* Active infections
* Cardiac failure, class I-IV
* Current anticoagulant or antiplatelet aggregation therapy
* Mitral and/or tricuspid valvopathy or valvular prosthesis; angina; severe arterial hypertension; chronic and/or paroxysmal atrial fibrillation; previous myocardial infarction
* Current lactation
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NCT_ID
NCT03454529
|
Study_NameThe Effect of Simvastatin on Breast Cancer Cell Growth in Women With Stage I-II Breast Cancer
| 1,409 |
Study Objectives
* Assessment of survival without progression of stage I MM in two groups: arm A: simple survey and arm B: administration of Zoledronate.
* Describe different progression's type noticed and define the prognosis factors of a fast evolution.
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: zometa
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: FACTORIAL
Masking: NONE
|
Inclusion Criteria:
* stage I multiple myeloma without bones injuries
Exclusion Criteria:
* abnormal kidney function
* VIH infection
* Hepatic incapacity
* pregnancy
* Associate pathology
|
NCT_ID
NCT00733538
|
Study_NameStage I Multiple Myeloma Treatment
| 10,729 |
Study Objectives
The goal of this clinical research study is to see if a new interferon which is given only once a week with ARA-C works as well as standard interferon and low dose ARA-C. The safety of this treatment will also be studied.
Conditions: Chronic Myeloid Leukemia
Intervention / Treatment:
DRUG: Peg Interferon Alpha 2b (Peg Intron), DRUG: Ara-C (cytosine arabinoside)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients age >= 12 years with a diagnosis of Ph-positive or bcr-positive CML in early chronic phase CML (diagnosis < 12 months).
* Serum bilirubin less than 2mg%, serum creatinine less than 2mg%, and a performance status of 2 or less on Zubrod scale.
* Patients under age 55 years should have HLA A,B,C, and DR typing performed on themselves and their siblings. Patients under age 20 years and patients with late chronic phase, accelerated phase or blastic phase will be offered allogeneic bone marrow transplantation from a matched sibling as the first priority.
Exclusion Criteria:
* Severe heart disease (Class III, IV) Psychiatric disability (psychosis) Pregnant or lactating females
* Women of pregnancy potential must practice birth control methods because of the potential risk of fetal teratogenecity with these agents.
* Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
* Definition of CML Phases: a. Early chronic phase: time from diagnosis to therapy < 12 months Late chronic phase: time from diagnosis to therapy > 12 months b. Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow. c. Accelerated phase CML: presence of any of the following features: - Peripheral or marrow blasts 15% or more - Peripheral or marrow basophils 20% or more - Thrombocytopenia < 100 x 109L unrelated to therapy - Documented extramedullary blastic disease outside liver or spleen
* Continuation of # 4 d. Clonal evolution defined as the presence of additional clones other than the Ph chromosome is part of accelerated phase CML. Ph chromosome variants or complex Ph chromosome translocations are not considered to indicate disease acceleration. We have recently found clonal evolution to have a variable prognostic impact and may be suppressed with IFN-A therapy (22,23). Hence these patients will be eligible if no other therapy (22,23). Hence these patients will be eligible if no other accelerated phase signs are present.
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NCT_ID
NCT00303290
|
Study_NamePEG Interferon Alpha 2B and Low-Dose Ara-C in Early Chronic Phase CML
| 16,538 |
Study Objectives
The purpose of this study is to determine whether nab-Paclitaxel (Abraxane®) and ramucirumab (Cyramza®) are effective when used in combination for treating patients with metastatic gastroesophageal cancer who have either progressed or not responded to prior therapy.
Conditions: Gastroesophageal Cancer
Intervention / Treatment:
DRUG: nab-paclitaxel, BIOLOGICAL: ramucirumab
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients with histologically confirmed metastatic adenocarcinoma of the esophagus, GE junction, or stomach who progressed on one prior line of chemotherapy in the metastatic setting.
* Measurable disease as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria Version 1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
* Adequate hematologic, renal, and hepatic functions
* Patients must have < Grade 2 pre-existing peripheral neuropathy (per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v 4.03)
* Life expectancy > 3 months
Exclusion Criteria:
* Patients who have received any other investigational agents, chemotherapy, biologic therapy, or radiation therapy within the 28 days prior to Day 1 of the study. For investigational, chemotherapy, or biologic therapy, patients will be allowed on study if five half-lives or greater have elapsed since last dose of drug or 28 days, whichever is shorter.
* Patients with prior taxane chemotherapy or agents which act by primary anti-angiogenic mechanisms.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit safety or compliance with study requirements or may interfere with the interpretation of the results.
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study initiation, or anticipation of need for major surgical procedure during the course of the study.
* Evidence or history of uncontrolled hypertension, proteinuria, non-healing wound, ulcer, bone fracture, hemoptysis, valvular disease, abdominal fistula, GI perforation, intra-abdominal abscess, bleeding diathesis or coagulopathy that would exclude patients from treatment with anti-angiogenesis agents.
* Therapeutic anticoagulation with coumarin-derivatives will not be permitted. However, a maximum daily dose of 1 mg will be permitted for port line patency. Anticoagulation with low molecular weight heparin or anti-Factor Xa agents will be allowed.
* Patients with other concurrent severe and/or uncontrolled medical disease which could compromise safety of treatment as so judged by treating physician (i.e., severely impaired lung function, severe infection, ventricular arrhythmias active ischemic heart disease, known active vasculitis of any cause, chronic liver or renal disease).
|
NCT_ID
NCT02317991
|
Study_NameStudy of Nab-Paclitaxel and Ramucirumab as Second-line Treatment for Patients With Metastatic Gastroesophageal Cancer
| 3,009 |
Study Objectives
Open-label, randomized, multicenter, Phase II trial designed to estimate the efficacy of CAPTEM versus FOLFIRI as second line treatment in MGMT methylated, RAS mutated advanced CRC patients who have progressed on or after first-line oxaliplatin containing chemotherapy for metastatic disease. MGMT will be assessed centrally at Pathology Department of Fondazione IRCCS Istituto Nazionale dei Tumori prior to enrollment. A minimum of ten 3-micron unstained sections on charged slides of tumor will be required and methylation status will be provided within a maximum of seven days to the Study Centers. Presence of RAS mutation will be assessed at each local participating center. Eligible patients will be randomized in a 1:1 ratio to one of two treatment arms:
* Arm A (experimental arm): CAPTEM
* Arm B (control arm): FOLFIRI Study treatment will be given in cycles repeated every 28 days for Arm A and every 14 days for Arm B. Patients in Arm A will receive capecitabine at the oral dose of 1500 mg/mq/die bid from day 1 to day 14 every 28 days plus temozolomide 150 mg/mq/die bid starting on day 9 to 14 every 28 days. Patients in Arm B will receive FOLFIRI chemotherapy starting Day 1 q2w (every cycle) starting on Day 1 of Cycle 1. FOLFIRI consists of irinotecan (starting dose of 180 mg/m2) on day one only; 5-FU 7 (starting bolus and 22-hour infusional doses of 400 mg/m2 and 600 mg/m2, respectively), and leucovorin (racemic, starting dose of 200 mg/m2 or L-form, starting dose of 100 mg/m2) for two consecutive days. Treatment will continue for up to 6 cycles in Arm A and up to 12 cycles in Arm B or up to disease progression, unacceptable toxicity or informed consent withdrawal. Randomization will be stratified across the treatment arms by the following predefined stratification variables: disease progression within 9 months from the start of first-line oxaliplatin-containing chemotherapy (\< vs. ≥9 months); prior bevacizumab in combination with oxaliplatin-based chemotherapy (yes vs. no). Efficacy assessments will be performed every 2 cycles in Arm A and every 4 cycles in Arm B until progression. The study is expected to enrol approximately 82 patients who meet the eligibility criteria.
Conditions: Metastatic Colorectal Cancer
Intervention / Treatment:
DRUG: Capecitabine, DRUG: Temozolomide, DRUG: Irinotecan, DRUG: Fluorouracil, DRUG: Leucovorin
Location: Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Signed Informed Consent Form
* Histologically or cytologically confirmed adenocarcinoma of the colon and/or rectum, with MGMT promoter methylation and RAS mutation.
* Progressive disease on or after a first-line oxaliplatin containing chemotherapy regimen for mCRC with or without bevacizumab or other anti-angiogenic drugs. Patients must have received oxaliplatin-containing chemotherapy for >= 3 months. No more than one prior chemotherapy regimen for metastatic disease is allowed. 8
* Disease measurableRECIST v1.1
* Age >= 18 years and <= 75 years
* Life expectancy >= 12 weeks
* ECOG Performance Status of 0 1
* Adequate hematologic and end-organ function, defined by laboratory results obtained within 14 days prior to first administration: ANC >= 1500/μL Platelet count >= 100,000/μL Hemoglobin >= 9.0 g/dL Albumin >= 2.5 g/dL
* Total bilirubin <= 1.5 × the upper limit of normal (ULN)
* AST, ALT, and/or alkaline phosphatase <= 2.5 × ULN, with the following exceptions: Patients with documented hepatic metastases are eligible with AST, ALT, and/or alkaline phosphatase <= 5 × ULN. Patients with documented bone metastases are eligible with alkaline phosphatase <= 5 × ULN.
* Serum creatinine <= 1.5 × ULN, or creatinine clearance >= 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation: (140 - age) × (weight in kg) × (0.85 if female) 72 × (serum creatinine in mg/dL)
* INR and aPTT <= 1.5 × ULN
* documented agreement (by patient and/or partner) to use an effective means of contraception (e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of the study and for 60 days for female patients or 150 days for male patients with partners of childbearing potential after the last infusion of study treatment.
* Consent to provide mandatory archival tumor tissue for biomarker testing
Exclusion Criteria:
* Prior treatment with irinotecan and temozolomide
* Major surgical procedure within 4 weeks and radiotherapy within 2 weeks prior to Day 1 Cycle 1
* Symptomatic hypercalcemia requiring continued use of bisphosphonate.
* Known clinically significant dihydropyrimidine 9 dehydrogenase deficiency
* Current severe, uncontrolled systemic disease Active infection requiring IV antibiotics
* History of heart failure of any New York Heart Association criteria or serious cardiac arrhythmia requiring treatment (except for atrial fibrillation and paroxysmal supraventricular tachycardia)
* History of myocardial infarction within 6 months prior to Cycle 1, Day 1, or history of unstable angina
* Known clinically significant liver disease,or current alcohol abuse
* History of bleeding diathesis or coagulopathy other than that due to anticoagulation therapy
* Patients receiving oral coumarin-derived anticoagulants
* Active haemoptysis within 30 days prior to Cycle 1, Day 1
* HIV infection
* Untreated/active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible provided they meet all of the following criteria: Measurable disease outside the CNS as defined by RECIST v1.1.Radiotherapy completed >= 4 weeks prior to Cycle, 1 Day
* Pregnancy or lactation. Women of childbearing potential (including those who have had a tubal ligation) must have a documented negative serum pregnancy test within 14 days prior to Cycle 1, Day 1.
* Inability to take oral medications.
* Malignancies other than CRC within 3 years prior to randomization, with the exception of adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix
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NCT_ID
NCT02414009
|
Study_NameStudy to Compare CAPTEM vs FOLFIRI as Second Line Treatment in Advanced, Colorectal Cancer Patients
| 18,070 |
Study Objectives
This study compares the biological activity of cabazitaxel (6 cycles) to that of docetaxel (6 cycles) in metastatic castrate-resistant prostate cancer (mCRPC) patients with docetaxel resistant mCRPC defined as ≥5 circulating tumor cells (CTCs) / 7.5 mL after 2 cycles of docetaxel.
Patients with docetaxel resistant metastatic castration-resistant prostate cancer (mCRPC) based on circulating tumor cell (CTC) enumeration (patients with ≥5 CTCs / 7.5 mL before docetaxel chemotherapy and after 2 cycles of docetaxel) will receive either 6 additional cycles of docetaxel or 6 additional cycles of cabazitaxel after randomisation.
A cohort of patients with docetaxel sensitive metastatic castration-resistant prostate cancer (mCRPC) based on circulating tumor cell (CTC) enumeration (patients ≥5 CTCs / 7.5 mL before docetaxel chemotherapy and \<5 CTCs / 7.5 mL after 2 cycles of docetaxel) will receive 6 additional cycles of docetaxel.
Conditions: Prostate Carcinoma, Castration-resistant Prostate Cancer, Circulating Tumor Cells, Chemotherapy
Intervention / Treatment:
DRUG: Cabazitaxel, DRUG: Docetaxel
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Written informed consent signed prior any study-related procedures
* Adult men >=18 years
* Histologically confirmed prostate adenocarcinoma
* Metastatic disease as evidenced by imaging (bone scan, CT-scan, MRI and/or PET-choline).
* Documented progressive disease while receiving continuous hormonal treatment with luteinizing hormone-releasing hormone (LH-RH) agonist or antagonist or after surgical castration (at least one visceral or soft tissue metastatic lesion, including a new lesion). Patient with non-measurable disease must have documented rising prostate-specific antigen (PSA) levels or appearance of new lesion
* Effective castration assessed by testosterone levels <=50 ng/dL
* Patients with a Eastern Cooperative Oncology Group (ECOG) performance status <=2
* Patients affiliated to social security scheme
Exclusion Criteria:
* Prior chemotherapy for metastatic prostate cancer except estramustine <1 year from the end of adjuvant and/or neoadjuvant chemotherapy for localized disease <1 year from the end of chemotherapy for de novo metastatic prostate cancer
* Prior isotope therapy, whole pelvic radiotherapy or radiotherapy to >30% of bone marrow
* Less than 1 month elapsed from prior treatment with radiotherapy, surgery and less than 2 weeks from any previous hormonal treatment except for LH-RH agonists/antagonists (which are to be continued). Patients may be treated with bisphosphonates prior to study entry which should be pursued,
* History of brain metastases, uncontrolled spinal cord compression, carcinomatous meningitis or new evidence of brain or leptomeningeal disease
* Patient with any of the following abnormal laboratory tests: hemoglobin <10 g/dL, absolute neutrophil count <1.5 x 10⁹/L, platelets <100 x 10⁹/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >1.5 x upper limit of normal (ULN), total bilirubin >1.0 ULN, creatinine clearance <40 ml/mn (MDRD)
* History of hypersensitivity to polysorbate 80 or docetaxel
* Contraindication to the use of corticosteroids
* Peripheral neuropathy grade >=2 according to NCI CTCAE v4.0
* Ventricular ejection fraction <50% (echography or scintigraphy)
* Any of the following within 6 months prior to study entry: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, stroke or transient ischemic attack
* Any of the following within 3 months prior to study entry: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, inflammatory bowel disease, pulmonary embolism or other uncontrolled thromboembolic event
* Other severe acute or chronic medical or psychiatric condition, or laboratory abnormally that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
* Planned vaccination with a live or live-attenuated vaccines
* Participation in another clinical trial and any treatment with any investigational drug within 30 days prior to randomization
* Any illness or problem including geographic, psychiatric or psychological which is incompatible with being monitored during the trial
* Patients with reproductive potential who do not agree to use effective method of contraception during the treatment
* Person deprived of their liberty or under protective custody or guardianship
|
NCT_ID
NCT03101046
|
Study_NameTreatment of Metastatic Castrate Resistant Prostate Cancer Patients According to Circulating Tumor Cells Kinetic
| 11,093 |
Study Objectives
A total of 60 female patients (30 patients in each group) with cutaneious warts diagnosed by a consultant dermatologist on physical examination were included in this study.
In Group A patients were subjected to liquid nitrogen cryotherapy (-196 0C) while patients in Group B were subjected to vitamin D3 (5mg/ml) for 3 sessions at every 3 weeks interval. Effectiveness in both groups was ascertained in terms of \> 50% reduction in wart size by an expert dermatologist on physical examination at the end of third session. Patients were followed for further 6 weeks after last session to look for any sort of recurrence and remission.
Conditions: Cutaneous Warts
Intervention / Treatment:
DRUG: liq nitrogen, DRUG: intralesional vitamin D3
Location: Pakistan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: OTHER
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Patient of cutaneous warts presented in dermatology department.
Exclusion Criteria:
* Immunosuppressed patients
* chronic skin diseases like eczema or autoimmune disease
* diabetes mellitus
* cold sensitivity , skin allergies
* pregnancy, and lactation
* periungual warts
|
NCT_ID
NCT05739786
|
Study_NameComparisom of Liquid Nitrogen and Vitamin D3 in The Treatment of Cutaneous Warts
| 4,014 |
Study Objectives
Resveratrol is purported to possess cancer preventive activity, especially for colon cancer, though its mechanisms of action are not well defined. Resveratrol is found in the skin of grapes and has anti-oxidative and pro-apoptotic effects on cancer cell lines in vitro. The main dietary sources of resveratrol are grapes, grape products, and red wine, and small amounts may be found in mulberries. A prior report and compelling preliminary data from our laboratory suggest that resveratrol modulates Wnt signaling, a signaling pathway which is activated in over 85% of colon cancers. In this proposal, studies were performed to define the actions of resveratrol on the Wnt signaling pathway in a clinical trial in which patients with colon cancer received treatment with Resveratrol, and correlative laboratory studies examined its effects directly on colon cancer and normal colonic mucosa. These studies provided data on the mechanisms of resveratrol action and provided a foundation for future prevention trials, correlative studies and therapeutic clinical research with this agent.
Conditions: Colon Cancer, Cancer
Intervention / Treatment:
DRUG: Resveratrol
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients diagnosed with colon cancer by colonoscopic biopsy and tissue obtained under UCI04 <= age <= 05.
* Patients with a plan for surgical resection at UCIMC within 2 <= age <= 4 weeks of enrollment.
Exclusion Criteria:
* Surgical resection to be performed at a facility other than UCIMC.
* Patients under 18 years.
|
NCT_ID
NCT00256334
|
Study_NameResveratrol for Patients With Colon Cancer
| 7,455 |
Study Objectives
The prevalence of malnutrition is common among patients with colorectal cancer. Chemotherapy induced side effects may impact negatively on nutrition intake thus increase the risk of malnutrition and serious complications for patients. Purpose is to test the effect of empowering education on activation and knowledge level among patients with colorectal cancer during the chemotherapy. Secondary outcomes are quality of life and malnutrition.
A two-arm, single center, patient blinded superiority trial with stratified randomization (1:1) and with repeated measures is used to measure the effectiveness of face-to-face education on nutrition intake related chemotherapy induced side-effects' self-care compared to standard care. Eligibility criteria are adult patients diagnosed with colorectal cancer and receiving intra venous chemotherapy treatment. Patients are recruited in one university hospital outpatient clinic in Finland. Experienced oncology nurse delivers the intervention two weeks after the first chemotherapy. Primary outcomes are activation in self-care and knowledge level. Secondary outcomes are quality of life and risk of malnutrition measured at baseline (M0) and after eight (M1) and 16 weeks (M2) after the intervention.
The study will provide knowledge of nurse-led educational intervention on self-care among patients with colorectal cancer. The findings will contribute to patient education and self-care, thus better quality of life.
Conditions: Patient Empowerment, Patient Activation, Self Care, Cancer of Colon, Cancer of Rectum
Intervention / Treatment:
BEHAVIORAL: Educational nursing intervention on nutrition intake related chemotherapy induced side-effects' self-care among the patients with colorectal cancer
Location: Finland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE
|
Inclusion Criteria:
* able to speak and understand Finnish
* receiving chemotherapy every three weeks in outpatient clinic: oxaliplatin+capecitabine= Xelox; irinotecan + capecitabine = Xeliri; Xelox or Xeliri + Bevacizumab
Exclusion Criteria:
* weak physical, psychological or cognitive function that prevents participation
* not able to understand Finnish
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NCT_ID
NCT04160650
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Study_NameEducational Nursing Intervention Among Patients With Colorectal Cancer During Chemotherapy
| 12,913 |
Study Objectives
The primary objectives of this study are to assess the feasibility (completion of full treatment) in both arms and to assess endoscopic complete response rate in both arms.
The secondary objective of this study is to assess the toxicity profile of each arm using the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) scale (V.3).
Conditions: Esophageal Neoplasms
Intervention / Treatment:
DRUG: FOLFOX 4, DRUG: 5-FU / Cisplatin
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
Patients with:
* Histologically proven adenocarcinoma, squamous cell or adenosquamous carcinoma of the esophagus
* Inoperable esophageal carcinoma (disease status: any T, N0 or N1, M0 or M1a) or surgical contraindication conditions
* No prior treatment for esophageal cancer (surgery, laser, chemo- or radiotherapy)
* Oesophageal dilatation is allowed before or during the treatment, but prior esophageal prosthesis is not allowed
* Peripheral neuropathy <= NCI-CTC grade 1
* Age >= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 2
* Sufficient (oral or with gastrostomy) calorific intake (> 1000 Kcal/m2/day)
* Life expectancy >= 3 months
* Adequate bone marrow reserve, normal renal and liver functions:
* Neutrophil count >= 1500/mm³
* Platelet count >= 100,000/mm³
* Hemoglobin >= 10 g/dl (after transfusion, if necessary)
* Creatinine levels <= 1.5 x the upper normal limit of institutional values (ULN)
* Total bilirubin level < 1.5 x ULN
* ALT/AST < 2.5 x ULN
* Prothrombin time >= 60%
* Laboratory values obtained the week preceding study entry
* Signed informed consent (prior to all study procedures)
* Start of treatment within 28 days of inclusion.
Exclusion Criteria:
* Metastatic disease except for third upper or cervical esophagus tumor with regional nodes, or third lower esophagus tumor with celiac nodes (M1a)
* Multiple carcinomas of the esophagus
* Small cell or undifferentiated carcinoma of the esophagus
* Complete dysphagia (grade 4 NCI-CTC); patient with exclusive parenteral nutrition.
* Weight loss > 20% normal body weight
* Pregnant or breast-feeding women
* Fertile patient not using adequate contraception
* Peripheral sensitive neuropathy with functional impairment
* Auditory disorders
* History of prior malignancies (other than cured non melanoma skin cancer, cured cervical carcinoma in situ or stage I or II node negative head and neck cancer cured > 3 years ago)
* Prior cervical, thoracic and abdominal radiotherapy with field overlapping the proposed oesophageal radiotherapy field
* Tracheo-oesophageal fistula or invasion of the tracheo-bronchial tree
* Previous myocardial infarction (inferior or equal to 6 months). Patients with a previous myocardial infarction superior to 6 months, could be included only if: no transient ischemia is shown by thallium myocardial scintigraphy and favourable advice for chemotherapy is obtained from a cardiologist.
* Other serious illness or medical conditions (such as symptomatic coronary disease, left ventricular failure or uncontrolled infection)
* Arterial disease stage II to IV according to the Leriche and Fontaine classification
* Treatment with any other experimental drugs or participation in another clinical trial within 30 days of study screening
* Concurrent treatment with any other anti-cancer therapy
* Concurrent treatment with phenytoin and yellow fever vaccine; geographical, social or psychological circumstances preventing regular follow-up.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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NCT_ID
NCT00160030
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Study_NameStudy Comparing Radiochemotherapy With Folfox 4 Regimen or 5FU-Cisplatin in Patients With Inoperable Esophageal Cancer
| 3,863 |
Study Objectives
This phase II trial studies how well combination chemotherapy and dasatinib works in treating participants with Philadelphia-positive or B-cell receptor-ABL positive acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy in combination with dasatinib may work better in treating participants with Philadelphia-positive or BCR-ABL positive acute lymphoblastic leukemia.
Conditions: Acute Lymphoblastic Leukemia, BCR-ABL1 Fusion Protein Expression, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Philadelphia Chromosome Positive, Recurrent Acute Lymphoblastic Leukemia, t(9;22)
Intervention / Treatment:
DRUG: Cyclophosphamide, DRUG: Cytarabine, DRUG: Dasatinib, DRUG: Dexamethasone, DRUG: Doxorubicin, DRUG: Methotrexate, DRUG: Prednisone, DRUG: Vincristine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Diagnosis of one of the following: Previously untreated Ph-positive acute lymphoblastic leukemia (ALL) (either t(9;22) and/or BCR-ABL positive) (includes patients initiated on first course of hyper-CVAD before cytogenetics known). These groups will be analyzed separately. After 1 <= age <= 2 courses of chemotherapy with or without imatinib mesylate (Gleevec). If they achieved complete response (CR), they are assessable only for event-free and overall survival, or if they failed to achieve CR, they are assessable for CR, event-free, and overall survival. Patients with relapsed Ph-positive ALL or lymphoid blast phase of chronic myelogenous leukemia (CML)
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Adequate liver function (bilirubin less than or equal to 3.0 mg/dl, unless considered due to tumor), and renal function (creatinine less than or equal to 3.0 mg/dl, unless considered due to tumor)
* Adequate cardiac function as assessed clinically
* Signed informed consent
Exclusion Criteria:
* Active serious infection not controlled by oral or intravenous antibiotics
* Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator
* Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year
* Active grade III-V cardiac failure as defined by the New York Heart Association criteria. Uncontrolled angina, or myocardial infarction (MI) within 6 months. Diagnosed or suspected congenital long QT syndrome. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes). Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 470 msec). Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes (unless these can be changed to acceptable alternatives)
* Prior history of treatment with dasatinib
* Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control
* History of significant bleeding disorder unrelated to cancer, including:
* Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
* Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
* Patients with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia
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NCT_ID
NCT00390793
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Study_NameCombination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia.
| 19,117 |
Study Objectives
We hypothesize that changes in tumor gene expression profiles vary in response to different sequences and types of chemotherapy, and that gene expression changes will correlate with tumor response. We are also looking to correlate drug pharmacokinetics and treatment toxicity with genotype of drug metabolizing enzymes and tranporters.Patients with metastatic breast cancer and who have measurable primary breast tumor will be randomized to one of two alternating sequences of adriamycin and docetaxel. Serial tumor biopsies and plasma samples will be obtained for gene expression and proteomic studies to identify biomarkers that will predict for chemotherapy response.
Conditions: Metastatic Breast Cancer
Intervention / Treatment:
DRUG: doxorubicin, docetaxel
Location: Singapore
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Female, > 18 yearsyears.
* Histologic or cytologic diagnosis of breast carcinoma.
* Stage II to IV breast cancer with measurable primary breast tumor, defined as palpable tumor with both diameters 2.0cm or greater as measured by caliper.
* Patients must not have received prior chemotherapy or hormonal therapy for the treatment of breast cancer.
* Karnofsky performance status of 70 or higher.
* Estimated life expectancy of at least 12 weeks.
* Adequate organ function including the following:
- Bone marrow: White blood cells (WBC) >= 3.5 x 109/L Absolute neutrophil (segmented and bands) count (ANC) >= 1.5 x 109/L Platelets >= 100 x 109/L Haemoglobin >= 9g/dL
- Hepatic: Bilirubin <= 1.5 x upper limit of normal (ULN), ALT or AST <= 2.5x ULN, (or <=5 X with liver metastases) Alkaline phosphatase <= 2.5x ULN.
- Renal: creatinine <= 1.5x ULN
* Cardiac:
* Adequate cardiac function
* Signed informed consent from patient or legal representative.
* Patients with reproductive potential must use an approved contraceptive method if appropriate (eg, intrauterine device, birth control pills, or barrier device) during and for three months after the study. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
Exclusion Criteria:
* Prior treatment for locally advanced or metastatic breast cancer.
* Treatment within the last 30 days with any investigational drug.
* Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
* Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
* Pregnancy.
* Breast feeding.
* Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
* Poorly controlled diabetes mellitus.
* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
* Symptomatic brain metastasis.
* History of significant neurological or mental disorder, including seizures or dementia.
* Peripheral neuropathy of >= CTC grade 2.
* History of hypersensitivity to drugs formulated in Tween 80, the vehicle used for commercial docetaxel formulations.
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NCT_ID
NCT00212082
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Study_NameGene Expression Profiles in Predicting Chemotherapy Response in Breast Cancer
| 1,895 |
Study Objectives
Blood samples will be obtained from newly diagnosed GBM patients treated with combined radiotherapy (RT), temozolomide (TMZ) and bevacizumab (BEV) at specific time points. The primary outcome is the shift in T reg cell fraction a defined by determining the proportion of CD4 cells that are CD4+ CD25.
Conditions: Glioblastoma Multiforme
Intervention / Treatment:
DRUG: Bevacizumab
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: BASIC_SCIENCE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Histologically proven GBM
* Karnofsky status equal to or greater than 60%
Exclusion Criteria:
* Inadequately controlled hypertension
* Prior history of hypertension crisis or hypertensive encephalopathy
* History of stroke or transient ischemic attach within 12 months
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NCT_ID
NCT01091792
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Study_NameExploratory Study of the Modulation of the Immune System by VEGF Blockade in Patients With Glioblastoma Multiforme (GBM)
| 5,442 |
Study Objectives
This is a 2-part, multicenter, open-label, randomized study of dinutuximab and irinotecan versus irinotecan alone in subjects with relapsed or refractory small cell lung cancer (SCLC). Part 1 of the study involves intrasubject dose escalation to evaluate the safety and tolerability of dinutuximab in combination with irinotecan. Part 2 of the study is designed to determine whether dinutuximab plus irinotecan prolongs overall survival (OS) compared with irinotecan alone. Subjects in Part 2 will be randomized in a 2:2:1 fashion to 1 of 3 treatment groups: (A) irinotecan; (B) dinutuximab plus irinotecan; or (C) topotecan. Randomization will be stratified by duration of response to prior platinum therapy (relapse-free period \<3 months or ≥3 months).
Conditions: Small Cell Lung Cancer
Intervention / Treatment:
BIOLOGICAL: Dinutuximab, DRUG: Irinotecan, DRUG: Topotecan
Location: Georgia, Poland, Thailand, United Kingdom, Australia, Lithuania, France, Korea, Republic of, India, Philippines, Canada, Slovakia, Ukraine, Spain, Italy, Taiwan, Romania, Hong Kong, Malaysia, United States, Bulgaria, Russian Federation, Hungary
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria:
* Have histologically or cytologically confirmed SCLC (undifferentiated small-cell carcinoma arising in or consistent with lung cancer origin).
* Documented relapse or disease progression during or after first-line platinum-based therapy (subjects refractory to initial platinum-based therapy are eligible).
* Have no curative therapy available.
* Have a life expectancy of at least 12 weeks.
* Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Have adequate bone marrow and hepatic function.
* Have calculated creatinine clearance (CrCL) >=30 mL/minute or serum creatinine <=1.5 times below the upper limit of normal.
* Women of reproductive potential must not be pregnant or breastfeeding and have a negative urine or serum pregnancy test obtained within 7 days prior to the first dose of study treatment.
* Subjects must agree to consistently use 2 forms of highly effective contraception/birth control between signing of the informed consent and 60 days after the last study drug administration.
Exclusion Criteria:
* Candidate for re-treatment with original platinum-based regimen as second-line therapy.
* Prior treatment with irinotecan, topotecan, or dinutuximab.
* Have active brain metastases. Subjects with brain metastases are allowed if they completed definitive brain therapy, are asymptomatic and radiologically stable, and if they are not currently receiving corticosteroids or radiation.
* Have mixed small cell and non-small cell histologic features.
* Have a previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis [carcinoma in situ]) or any previous cancer curatively treated <3 years ago.
* Have a history or current evidence of uncontrolled cardiovascular disease.
* Have not recovered from prior surgery, significant trauma, systemic anticancer therapy, radiation therapy or investigational therapy to Grade 1 or better toxicity prior to enrollment (Part 1) or randomization (Part 2).
* Have had organ allograft or hematopoietic transplantation.
* Known to be human immunodeficiency virus (HIV) positive.
* Have an active infection requiring treatment or one that is clinically serious in the Investigator's opinion.
* Have received a live vaccine within 6 months of enrollment (Part 1) or randomization (Part 2).
* Exposure to strong CYP3A4 and/or UGT1A1 inhibitors and strong CYP3A4 inducers within 14 days of enrollment (Part 1) or randomization (Part 2).
* Have any clinical condition that is considered unstable or might jeopardize the safety of the subject and/or influence the subject's compliance in the study.
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NCT_ID
NCT03098030
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Study_NameDinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer
| 569 |
Study Objectives
This phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated metastatic colorectal cancer (CRC).
The clinical benefit of AMG 655 in combination with mFOLFOX6 and bevacizumab will be measured by progression-free survival, objective response rate, time to response, duration of response, and overall survival. This study is also designed to evaluate the safety and tolerability of AMG 655 in combination with mFOLFOX6 and bevacizumab and to evaluate anti-AMG 655 antibody formation and the pharmacokinetics of AMG 655.
Conditions: Metastatic Colorectal Cancer, Colon Cancer, Colorectal Cancer, Rectal Cancer
Intervention / Treatment:
DRUG: Placebo, DRUG: AMG 655, DRUG: Modified FOLFOX6, DRUG: Bevacizumab
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE
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Inclusion Criteria:
* Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
* Subjects with measurable or unmeasurable disease
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* Men or women at least 18 years
* Adequate hematologic, renal, hepatic and coagulation function
Exclusion Criteria:
* History or known presence of central nervous system (CNS) metastases
* Prior chemotherapy or other systemic therapy for advanced or metastatic CRC
* Any investigational agent or therapy for advanced or metastatic CRC
* Clinically significant cardiac disease
* Clinically significant peripheral neuropathy
* Active inflammatory bowel disease
* Recent gastrointestinal ulcer or hemorrhage
* Recent arterial thrombotic event or pulmonary embolus
* Recent history of clinically significant bleeding, bleeding diathesis, or coagulopathy
* Recent major surgical procedure or not yet recovered from major surgery
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NCT_ID
NCT00625651
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Study_NamePhase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer
| 22,238 |
Study Objectives
This randomized pilot phase I trial will evaluate if quercetin enhances the uptake of green tea polyphenols in the prostate tissue of men taking green tea extract and undergoing radical prostatectomy. Side effects of green tea extract and quercetin in combination with green tea extract will also be evaluated. In preclinical studies, green tea polyphenols have anticancer and cancer preventative effects in a number of malignancies. Likewise, in preclinical studies quercetin was found to enhance the anticancer effects of green tea. This trial is designed to translate these findings forward in a short-term human intervention trial.
Conditions: Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer
Intervention / Treatment:
DIETARY_SUPPLEMENT: green tea extract, DRUG: quercetin, OTHER: placebo, PROCEDURE: therapeutic conventional surgery, OTHER: laboratory biomarker analysis
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
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Inclusion Criteria:
* Subjects consent to participate in the trial
* The subject has a diagnosis of adenocarcinoma of the prostate
* The subject is scheduled to undergo radical prostatectomy
* The subject agrees to stop consuming tea or tea-containing products and quercetin supplements throughout the entire intervention period except for the green tea extract and quercetin provided during study intervention
Exclusion Criteria:
* History of hepatitis or liver dysfunction
* Ongoing alcohol abuse
* Significant medical or psychiatric conditions that would make the patient a poor protocol candidate
* Prior sensitivity or allergic reaction to tea, tea products or tea and quercetin supplements
* Allergies to multiple food items or nutritional supplements
* Taking luteinizing hormone-releasing hormone (LHRH) agonists, androgen receptor blocking agents, finasteride, or has undergone bilateral orchiectomy
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NCT_ID
NCT01912820
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Study_NameEffect of Quercetin on Green Tea Polyphenol Uptake in Prostate Tissue From Patients With Prostate Cancer Undergoing Surgery
| 1,816 |
Study Objectives
The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) in phase 1 and to determine the combined response rate of clinical response CR and very good partial response (VGPR) in phase 2 of oral (PO) ixazomib administered twice-weekly in combination with lenalidomide and low-dose dexamethasone in a 21-day cycle in participants with newly diagnosed multiple myeloma (NDDM).
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Ixazomib, DRUG: Lenalidomide, DRUG: Dexamethasone
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Male or female patients >= 18 years
* Symptomatic multiple myeloma or asymptomatic myeloma with myeloma-related organ damage diagnosed according to standard criteria
* Measurable disease as specified in study protocol
* Hematologic, liver, and renal function as specified in the study protocol.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse; must also adhere to the guidelines of the lenalidomide pregnancy prevention program
* Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse AND must adhere to the guidelines of the lenalidomide pregnancy prevention program
* Must be able to take concurrent aspirin 325 mg daily
* Voluntary written consent
Exclusion Criteria
* Peripheral neuropathy that is greater or equal to Grade 2
* Female patients who are lactating or pregnant
* Major surgery or radiotherapy within 14 days before the first dose of study drug
* Uncontrolled infection requiring systematic antibiotics within 14 days before the first dose of study drug
* Diarrhea (> Grade 1)
* Prior systemic therapy for multiple myeloma, including investigational drugs (prior treatment with corticosteroids or localized radiation therapy dose not disqualify the patient)
* Systemic treatment with strong inhibitors of CYP1A2, strong inhibitors of CYP3A, or strong CYP3A inducers, or use of Ginkgo biloba or St. John's wort within 14 days before the first dose of study treatment
* Central nervous system involvement
* Diagnosis of smoldering multiple myeloma, Waldenstrom's macroglobulinemia, POEMS syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome
* Evidence of current uncontrolled cardiovascular conditions
* Prior or concurrent deep vein thrombosis or pulmonary embolism
* Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
* Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
* Known allergy to any of the study medications
* Known gastrointestinal condition or procedure that could interfere with swallowing or the oral absorption, or tolerance of IXAZOMIB
* Diagnosed or treated for another malignancy within 2 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease with the exception of nonmelanoma skin cancer or any completely resected carcinoma in situ
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NCT_ID
NCT01383928
|
Study_NameStudy of Oral IXAZOMIB in Combination With Lenalidomide and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma
| 19,778 |
Study Objectives
This was an open-label, single-arm, multi-center, Phase II study to determine the activity of nab-paclitaxel plus lapatinib in the first and second-line setting in women with ErbB2 overexpressing metastatic breast cancer (MBC). Sixty subjects were to be enrolled in the study. Subjects were to receive nab-paclitaxel (100 mg/m2 intravenously once weekly for 3 weeks, followed by a rest week in a 4-week cycle) plus lapatinib (1000 mg once daily). Subjects were to receive treatment until disease progression or withdrawal from the study. The primary objective of this study was to evaluate overall tumor response rate of lapatinib in combination with nab-paclitaxel administered in women with ErbB2 overexpressing MBC who received no chemotherapeutic regimen in the metastatic setting. Secondary objectives included progression-free survival, overall survival, duration of response, time to response and time to progression and safety. Safety and efficacy assessments were to be performed at 8 and 12 week intervals, and at the end of treatment.
Subject: Metastatic Breast Cancer, ErbB2, First-line therapy, Lapatinib, Nab-paclitaxel
Conditions: Neoplasms, Breast
Intervention / Treatment:
DRUG: Lapatinib/nab-Paclitaxel
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Masking: NONE
|
Inclusion Criteria:
A subject was eligible for inclusion in this study only if all of the following criteria apply:
* Subjects must have histologically confirmed invasive breast cancer with Stage IV disease at primary diagnosis or at relapse after curative-intent surgery. Where the disease was restricted to a solitary lesion, the neoplastic nature of the lesion should have been confirmed by cytology or histology.
* Documented amplification of ErbB2 3+ by immunohistochemistry or a positive score (>2.2) by FISH using a local laboratory result (which was considered sufficient in this study with no further verification by a central laboratory).
* Subjects must have received no more than one prior chemotherapeutic regimen in the metastatic setting.
* If a taxane had been administered in the neoadjuvant, adjuvant or metastatic setting, progression must have occurred >=12 months after completion of this treatment.
* Prior therapy with radiation for this breast cancer population was permitted if it was administered in the neoadjuvant or adjuvant non metastatic setting. Radiotherapy given in the metastatic setting, prior to initiation of study medication, was allowed to a limited area (e.g., palliative therapy and involving less than 25% of bone marrow), if it was not the sole site of disease. Subjects must have completed radiation treatment and recovered from all acute radiation treatment related toxicities (e.g., bone marrow suppression) prior to commencement of combination treatment.
* The subject must have received all prior chemotherapy treatment at least 4 weeks prior to enrollment in this study and must have recovered from all related toxicities. Subjects who have received weekly dose of prior chemotherapy e.g. gemcitabine or capecitabine may enroll 2 to 3 weeks after cessation of treatment provided that they have recovered from all related toxicities.
* Prior therapy with trastuzumab in the neoadjuvant, adjuvant or metastatic setting was permitted. The subject must have received all prior trastuzumab treatment at least 4 weeks prior to enrollment in this study and must have recovered from all related toxicities.
* Prior endocrine therapy was permitted in the neoadjuvant or adjuvant or metastatic setting. The subject must have received all prior endocrine treatment at least 1 week prior to enrollment in this study and must have recovered from all related toxicities.
* Prior diagnosis of cancer was allowed as long as the subject was free of disease for 5 years. Subjects with completely resected basal or squamous cell skin cancer, thyroid cancer or successfully treated cervical carcinoma in-situ were allowed if it had been 1 year or greater since definitive surgery.
* Subjects must have had measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines; defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter [LD] to be recorded) by mammogram, ultrasound or physical exam [Therasse, 2000].
* Subjects with liver metastases or stable chronic liver disease were permitted into the study.
* Women >=18 years:
* Non-child-bearing potential (i.e., women with functioning ovaries who had a current documented tubal ligation or hysterectomy, or women who were postmenopausal); or
* Child-bearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category included women with oligomenorrhoea (severe), women who were perimenopausal and young women who had begun to menstruate. These subjects must provided a negative serum pregnancy test at Screening and agree to 1 of the following:
* Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of study medication until 5 days after the final dose of study medication; or
* Consistent and correct use of one of the following acceptable methods of birth control:
* Male partner who was sterile prior to the female subject's entry into the study and was the sole sexual partner for that female subject.
* Implants of levonorgestrel.
* Injectable progestogen.
* Any intrauterine device with a documented failure rate of less than 1% per year.
* Oral contraceptives (either combined or progestogen only).
* Barrier methods, including diaphragm or condom with a spermicide.
* Considered by the Investigator to have a life expectancy of >=6 months.
* ECOG Performance Status (PS) of 0 or 1 (Karnofsky >=80%) [Oken, 1982].
* Subjects must have had normal organ and marrow function as below:
* Hematologic
* Absolute neutrophil count >=1.5 × 10^9/L
* Hemoglobin >=9 g/dL
* Platelets >=100 × 10^9/L
* Hepatic
* Serum bilirubin <= upper limit of normal (ULN)
* Aspartate aminotransferase <=3 × ULN without liver metastases and alanine aminotransferase <=5 × ULN if documented liver metastases
* Renal
* Serum creatinine <=1.5 mg/dL
* OR -
* Calculated creatinine clearance >=40 mL/min
* Subjects must have had a cardiac ejection fraction of >50% as measured by echocardiogram (ECHO) or multigated acquisition scan (MUGA) and within the institutional range of normal.
* Subjects with stable central nervous system metastases (stable for at least 3 months) as confirmed by computerized tomography (CT)/magnetic resonance imaging (MRI) or evidence of leptomeningeal involvement were eligible only if they were not taking steroids or enzyme-inducing anticonvulsants.
* Subject must have been free of gastrointestinal diseases that impede swallowing and retaining of oral medications.
* Signed, informed consent prior to registration.
* Bisphosphonate therapy for bone metastases was allowed; however, treatment must be initiated prior to the first dose of study medication. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, was not permitted.
* Subjects whose disease was estrogen receptor + and/or progesterone receptor + or unknown status were included in the study if they met the following criteria:
* They had symptomatic visceral disease that required chemotherapy.
* Significant visceral organ tumor burden
* The disease was considered by the Investigator to be progressing rapidly or life threatening.
* Subjects who have received prior endocrine therapy and who were no longer benefiting from this therapy.
Exclusion Criteria:
A subject was not be eligible for inclusion in this study if any of the following criteria apply:
* Subjects who received more than one prior chemotherapeutic regimen in the metastatic setting
* Subjects taking treatment with medications provided in the list of restricted medications and substances in the drug information section for lapatinib were not eligible for the study. This included human immunodeficiency virus-positive subjects receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with lapatinib.
* Prior treatment with lapatinib.
* Concurrent anticancer or concomitant radiotherapy treatment;
* Concurrent treatment with prohibited medications;
* Use of an investigational drug within 30 days or 5 half-lives, whichever was longer, preceding the first dose of investigational treatment, or, concurrent treatment with an investigational agent or participation in another clinical trial involving investigational agents.
* Known history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or nab-paclitaxel or excipients;
* Known history of uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would have limited compliance with study requirements.
* Had active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
* Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety.
* Pregnant or lactating females at any time during the study (due to the potential teratogenic or abortifacient effects of lapatinib and breastfeeding).
* Subjects with diseases affecting gastrointestinal function resulting in an inability to take oral medication, including; malabsorption syndrome, a requirement for iv alimentation, prior surgical procedures affecting absorption e.g. gastric resection and uncontrolled inflammatory bowel disease (e.g., Crohn's, ulcerative colitis).
* Peripheral neuropathy of Grade 2 or greater.
* Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment.
* History of prior malignancy. However, subjects who had been disease-free for 5 years, or subjects with completely resected basal or squamous cell skin cancer, thyroid cancer or successfully treated cervical carcinoma in situ were eligible if it had been at least 1 year since definitive surgery.
* or rendering of informed consent.
Other Eligibility Criteria Considerations:
* To assess any potential impact on subject eligibility with regard to safety, the Investigator must refer to the following document(s) for detailed information regarding warnings, precautions, contraindications, AEs, and other significant data pertaining to the investigational product(s) being used in this study: Clinical Investigator's Brochure (IB), SPM, and the nab-paclitaxel Product Label.
|
NCT_ID
NCT00709761
|
Study_NamePhase II Lapatinib Plus Nab-Paclitaxel As First And Second Line Therapy In her2+ MBC
| 19,711 |
Study Objectives
This study is going to test a cold atmospheric plasma device (CAP), in particular a floating electrode-dielectric barrier device (FE-DBD), to treat warts and molluscum. The treatment device in this study generates cold atmospheric plasma (gaseous ionized molecules) to rid the virus from the body. Based on the successes of previous dermatologic studies, FE-DBD is being tested for this study to treat warts and molluscum. Patients will be enrolled to test the efficacy and safety of this device. The duration of the study is 4-12 weeks depending on treatment clearance. The number of lesions will be chosen by the dermatologist. Patients will receive standard of care therapy and/or NTAP depending on the number of lesions.
Conditions: Verruca Vulgaris, Molluscum Contagiosum Skin Infection
Intervention / Treatment:
DEVICE: Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP), DEVICE: Cryotherapy, DRUG: Canthardin Collodion
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* All patients from 4 <= age <= 21 years with at least 1 lesion of either verruca vulgaris or molluscum contagiosum
* Willingness of the participant and their guardian to provide consent when applicable
Exclusion Criteria:
* Unwillingness to participate in the study
* Received any treatment on the lesion in the past month, as determined by review of participant medical record
* Immunodeficiency as determined by review of participant medical record
* Adverse response to prior treatments as determined by review of medical record
* Signs of self-resolution as determined by study team members
* Conditions that lead to excessive scarring as determined by study team members
* Facial and genital lesions as determined by study team members
|
NCT_ID
NCT05070754
|
Study_NameCold Atmospheric Plasma Device for Pediatric Molluscum and Verruca
| 22,613 |
Study Objectives
This is a single arm phase II trial to study the efficacy and safety of a Cdk inhibitor P276-00 in the treatment of squamous cell carcinoma of head and neck. Patients with recurrent or metastatic disease that is unresectable and incurable by radiation will be enrolled. Thirty eight evaluable patients need to be enrolled in the study. All patients will receive protocol treatment i.e. P276-00 as an intravenous infusion from day 1 to day 5 and from day 8 to day 12 in each 21 day cycle till progression of disease or unacceptable toxicity. Safety evaluations by means of recording vitals, physical examination and lab investigations like hematology and clinical chemistry will be undertaken at regular intervals in each cycle. Tumor measurements by spiral CT scan will be undertaken at baseline and at the end of every 2 cycles for response evaluation by RECIST criteria. All patients will be followed up for survival status till one year of cycle 1 day 1.
Conditions: Squamous Cell Carcinoma of Head and Neck
Intervention / Treatment:
DRUG: P276-00
Location: India
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Age more than or equal to 18 years
* Subjects with histologically or cytologically confirmed SCCHN that is recurrent and/or metastatic and judged incurable by surgery and/or radiation therapy and with zero to one line of chemotherapy for recurrent or metastatic disease at least 60 days prior to study entry.
* Measurable disease, defined as at least one unidimensionally measurable lesion >= 20 mm by conventional techniques or >=10 mm by spiral computerized tomography (CT) scan or magnetic resonance imaging (MRI)
* Tumor that is accessible to biopsy
* Eastern Cooperative Oncology Group (ECOG) performance status <= 2
* Life expectancy of at least three months
* Hemoglobin >= 8.0 gm/dL
* Absolute neutrophil count (ANC) >= 1000/mm3
* Platelet count >= 50,000/mm3
* Total bilirubin <=1.5X institutional upper limit of normal (ULN)
* Serum AST <= 3X institutional ULN
* Serum ALT <= 3X institutional ULN
* Serum creatinine <=1.5X institutional ULN
* Ability to understand and the willingness to sign a written informed consent document (ICD)
Exclusion Criteria:
* Nasopharyngeal carcinoma
* Prior treatment with P276 <= age <= 00 or other Cyclin dependent kinase (CDK) targeting agents
* History of allergic reactions attributed to compounds of similar chemical composition to P276 <= age <= 00
* Subjects who have received radiotherapy, chemotherapy or biologic/targeted anticancer agents within 60 days prior to Day 1 of study drug administration or have not recovered from adverse effects of any prior radiotherapy, chemotherapy or biologic/targeted agents.
* More than one chemotherapy regimen for the recurrent or metastatic disease
* Subjects who had received any other investigational drug within 1 month or within five half-lives of the other investigational agent, whichever is longer prior to Day 1 of study drug administration
* Subjects with QTc > 450 msec on 12 lead standard electrocardiogram (ECG)
* History of unstable angina or myocardial infarction or stroke within previous 6 months
* Subjects with uncontrolled inter-current illness including, but not limited to active infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Subjects known to be suffering from infection with HIV, Tuberculosis, Hepatitis C or Hepatitis B
* Known brain metastasis
* History of prior malignancy except for curatively treated basal cell or squamous cell carcinoma of skin, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or any other cancer for which the subject has been disease-free for at least 3 years
* Women who are pregnant or lactating
* Women of childbearing potential [defined as sexually mature women who have not undergone hysterectomy or who have not been naturally postmenopausal for at least 24 consecutive months (i.e. who have had menses any time in the preceding 24 consecutive months)] and men, not agreeing to use adequate contraception (e.g., hormonal or barrier method of birth control or abstinence) prior to study entry (after signing the ICD), during the period of study participation and for at least 4 weeks after withdrawal from the study, unless they are surgically sterilized
* Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at an unacceptable risk or deems the subject not suitable for participation in the study
|
NCT_ID
NCT00824343
|
Study_NameA Phase II Clinical Trial to Study the Efficacy and Safety of a New Drug P276-00 in Treatment of Recurrent and/or Locally Advanced Head and Neck Cancer
| 6,102 |
Study Objectives
This phase II trial is studying how well giving bevacizumab together with erlotinib works in treating patients with advanced liver cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and erlotinib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with erlotinib may kill more tumor cells
Conditions: Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer
Intervention / Treatment:
BIOLOGICAL: bevacizumab, DRUG: erlotinib hydrochloride
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Absolute neutrophil count >= 1,500/mm^3
* Creatinine =< 2 mg/dL
* Albumin >= 2.5 g/dL
* Total bilirubin =< upper limit of normal (ULN)
* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times ULN
* Alkaline phosphatase =< 5 times ULN
* Urine protein:creatinine ratio < 1.0 OR 24-hour urine protein < 1,000 mg
* Not pregnant or nursing:
No nursing for >= 6 months after completion of study treatment
* Negative pregnancy test
* Fertile patients must use effective contraception during study and for >= 6 months after completion of study treatment
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to bevacizumab or erlotinib hydrochloride
* No abnormalities of the cornea, including any of the following:
History of dry eye syndrome or Sjögren's syndrome; Congenital abnormality (e.g., Fuch's dystrophy); Abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose); Abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
* No stroke or transient ischemic attack within the past 6 months
* No uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
* No unstable angina pectoris within the past 6 months
* No symptomatic congestive heart failure
* No myocardial infarction within the past 6 months
* No serious uncontrolled cardiac arrhythmias
* No uncontrolled diabetes mellitus
* No active or uncontrolled infection
* No impaired GI function or disease that may significantly alter the absorption of erlotinib hydrochloride (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea, malabsorption syndrome, or bowel obstruction)
* Able to swallow tablets
* No psychiatric illness or social situation that would limit compliance with study requirements
* No history of nephrotic-range protein
* No history of bleeding diathesis
* No encephalopathy
* No serious nonhealing wounds, skin ulcers, or bone fractures
* No clinically significant peripheral vascular disease
* No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
* No history of a GI bleed that required procedural intervention (e.g., variceal banding, surgical shunt, transvenous intrahepatic porto-systemic shunt [TIPS]) within the past 3 months
* No significant traumatic injury within the past 28 days
* No other prior malignancy within the past 5 years except for the following:
Adequately treated basal cell or squamous cell skin cancer; Adequately treated in situ cervical cancer; Stage I or II cancer from which the patient is currently in complete remission; Stage I chronic lymphocytic leukemia
* Recovered from all therapy-related toxicities
* No more than 1 prior systemic or liver directed drug therapy including transarterial chemoembolization (TACE) (multiple TACEs will count as 1 prior regimen irrespective of their total numbers) that were used for HCC
* No chemotherapy for HCC within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C)
* No biological therapy or immunotherapy for HCC within the past 4 weeks
* Prior surgery, regional therapy (e.g., transarterial embolization), liver transplantation, or other liver-directed ablative therapies of discrete lesions allowed provided any related progressive or recurrent disease is documented
* No cryotherapy, radiofrequency ablation, ethanol injection, or photodynamic therapy within the past 6 weeks:
Indicator lesions must be outside the area of prior treatment OR if the lesion is inside the area of prior treatment, there must be clear evidence of disease progression associated with that lesion
* No core biopsy within the past 7 days
* No radiotherapy within the past 4 weeks
* No prior antiangiogenesis agent or antiepidermal growth factor receptor drug
* No prior treatment with hepatic arterial infusion with chemotherapy or yttrium Y 90-labeled microspheres
* No other concurrent investigational agents
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent anticancer therapy
* Concurrent full-dose anticoagulants (e.g., warfarin) with international normalized ratio (INR) > 1.2 allowed provided the following criteria are met:
An in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant (or on a stable dose of low molecular weight heparin)
* AND (continued from above) No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels, gastrointestinal [GI] ulceration, or known varices)
* No concurrent major surgical procedures
* Histologically confirmed hepatocellular carcinoma (HCC):
* No fibrolamellar subtype HCC
* Advanced disease
* Not a candidate for surgical resection or liver transplantation
* Measurable disease:
* Edges of the indicator lesion must be clearly distinct on CT scan
* Lesions that measure at least 1 cm but less than 2 cm only must use spiral CT imaging for both pre- and post-treatment tumor assessments
* Child's Pugh classification A or B
* No primary brain tumor, brain metastasis, or other central nervous system (CNS) diseases
* Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 1
* Platelet count >= 75,000/mm^3
* No major surgery (e.g., laparotomy), open biopsy, or minor surgery (e.g., insertion of a vascular access device) within the past 4 weeks
* No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
* No abdominal fistula, GI perforation, or intra-abdominal abscess within the past 28 days
* No concurrent prophylactic hematopoietic colony-stimulating factors
|
NCT_ID
NCT00365391
|
Study_NameBevacizumab and Erlotinib in Treating Patients With Advanced Liver Cancer
| 2,975 |
Study Objectives
Dose response curve to define the security and tolerable dose to be used for prevention and treatment of radiodermatitis in patients with breast or head and neck cancer.
Conditions: Radiodermatitis
Intervention / Treatment:
DRUG: Urea Dose A, DRUG: Urea Dose B, DRUG: Urea Dose C, DRUG: Chamomile Dose A, DRUG: Chamomile Dose B, DRUG: Chamomile Dose C
Location: Brazil
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Being an adult, over the age of 18 years
* Owning diagnosis of breast or head and neck cancer
* Being first referred to the radiotherapy protocol
* Have absence of radiodermatitis and integrates skin to start radiotherapy
* Not have presented anticipated reaction of hypersensitivity to chamomile or any plant of the family Asteraceae or Compositae or urea.
* Demonstrate conditions to continue the intervention in their home environment when needed.
Exclusion Criteria:
* Medical prescription for the procedure of data collection, some kind of intervention to prevent radiodermatitis.
|
NCT_ID
NCT02249884
|
Study_NameDose-Response Curve: Interventions to Prevent and Treat Radiodermatitis
| 17,364 |
Study Objectives
The purpose of this study is to find out the effectiveness and side effects of arsenic trioxide in combination with low-dose ara-C.
Conditions: Myelodysplastic Syndrome
Intervention / Treatment:
DRUG: Arsenic Trioxide (Tricenox), DRUG: Cytarabine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histologic diagnosis of high-risk MDS (IPSS int-2).
* No prior cytotoxic therapy for MDS or AML (patients may have received prior therapy with hematopoietic growth factors, immunomodulatory agents or 5-azacitidine).
Exclusion Criteria:
* Pregnant or lactating women.
* Absolute QT interval >460 msec in the presence of serum potassium and magnesium values within the normal range.
* Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents.
* Uncontrolled or severe cardiovascular or pulmonary disease.
|
NCT_ID
NCT00195104
|
Study_NameArsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AML
| 10,492 |
Study Objectives
The purpose of the trial is to determine the maximum tolerated dose (MTD) of BEZ235 and BKM120 in combination with weekly paclitaxel and weekly paclitaxel/trastuzumab.
Conditions: Metastatic or Locally Advanced Solid Tumors
Intervention / Treatment:
DRUG: BEZ235 + paclitaxel, DRUG: BKM120 + paclitaxel, DRUG: BEZ235 + paclitaxel + trastuzumab, DRUG: BKM120 + paclitaxel + trastuzumab
Location: Germany, Spain, Netherlands, Belgium, Switzerland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Adult patients with metastatic or locally advanced solid tumors, for whom weekly paclitaxel treatment is indicated (BEZ235-paclitaxel /BKM120-paclitaxel treatment)
* HER2+ metastatic or locally advanced breast cancer patients eligible for weekly paclitaxel and trastuzumab (BEZ235-paclitaxel-trastuzumab /BKM120-paclitaxel-trastuzumab treatment)
* Adult patients (>= 18 years) (males, females)
* World Health Organization (WHO) performance status <= 2
* Adequate bone marrow function:
* Adequate hepatic and renal function:
Exclusion Criteria:
* Patients with primary central nervous system (CNS) tumor or CNS tumor involvement. However, patients with a metastatic CNS lesion may participate in this trial, if the patient is > 4 weeks from therapy (including radiation and/or surgery) completion, clinically stable with respect to the tumor at the time of study entry, and not receiving enzyme-inducing antiepileptic drugs or corticosteroid therapy or taper, as treatment of the brain metastases
* Patients who have received prior systemic anticancer therapy within the following time frames
* Cyclical chemotherapy: <= 3 weeks before study treatment (6 weeks for patients treated with nitrosoureas)
* Biological therapy: <= 4 weeks before study treatment, except treatment with trastuzumab (both parts of the trial)
* Investigational drug: <= 4 weeks before study treatment
* Patients who have undergone major surgery <= 4 weeks before study treatment
* Patients receiving chronic treatment with corticosteroids or other immunosuppressive agents
* Patients with uncontrolled, unmanageable, treatment-refractory diabetes mellitus
* Active or history of major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, history of suicide attempt or ideation, or homicide, as judged by the investigator and/or based on recent psychiatric assessment
Other protocol-defined inclusion/exclusion criteria may apply
|
NCT_ID
NCT01285466
|
Study_NameA Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without Trastuzumab
| 190 |
Study Objectives
Participants will be taking 3 mg/kg ipilimumab intravenously over a 90-minute period every 3 weeks for a total of four doses. Tumor-infiltrating lymphocytes (TILs)will be analyzed for functional characteristics.
Conditions: Previously Untreated and Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma
Intervention / Treatment:
DRUG: Ipilimumab at 3 mg/kg dose
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Willing and able give written informed consent.
* Previously untreated (adjuvant interferon is acceptable), and histologically confirmed Stage III (unresectable) or Stage IV melanoma with at least 2 metastatic lesions, (one amenable to resection that measures over 0.75 cm3 by volume AND another amenable to 3 X core biopsy OR resection that measures over 0.5 cm3) at study entry AND at least 1 additional RECIST measurable lesion must be present for study entry, other than the 2 identified for resection/biopsy, defined as a lesion that can be accurately measured in two perpendicular diameters, as per RECIST by CT scan, MRI, or calipers by clinical exam.
* Subjects with asymptomatic or previously treated brain metastases are only eligible for enrollment provided they have evidence of 30 day stability of the brain metastasis prior to the date of registration. "Stability" being no change in the imaging modality used (CT or MRI) at the baseline and 30 day time point. (Systemic steroids should be avoided if possible, or the subject should be stable on the lowest clinically effective dose of steroids as they may interfere with the activity of ipilimumab if administered at the time of the first ipilimumab dose.)
* Must be at least 28 days since treatment with surgery or radiation, or immunotherapy (IFN-alpha), and recovered from any clinically significant toxicity experienced during treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of >= 16 weeks.
* Subjects must have the complete set of baseline (screening/baseline) radiographic images, including but not limited to brain, chest, abdomen, pelvis, and bone scans (if applicable). The images can be accepted if obtained 6 weeks before initiation of ipilimumab.
* Required values for initial laboratory tests: WBC > 2.0 x 109/L; ANC > 1.0 x 109/L; Platelets > 100 x 109/L; Hemoglobin > 90 g/L (> 80 g/L; may be transfused); Creatinine < 2.0 x ULN; AST/ALT < 2.5 x ULN for patients without liver metastasis, < 5 times for liver metastases; Bilirubin < 2.0 x ULN, (except patients with Gilbert's Syndrome, who must have a total bilirubin less than 51.3 µmol/L); INR < 1.3
* No active or chronic infection HIV, Hepatitis B, or Hepatitis C.
* Men and women, >= 18 years.
* WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of ipilimumab.
Exclusion Criteria:
* Sex and Reproductive Status: a) WOCBP and men of fathering potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 26 weeks after the last dose of investigational product. Adequate contraception for women is defined as oral contraceptives, other hormonal contraceptives or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides), abstinence or sterile partner (eg, vasectomy). Adequate contraception for men is defined as abstinence, sterile partner, condoms, or vasectomy. b) Women who are pregnant or breastfeeding.
* Target Disease Exceptions: a) Subjects on any other systemic therapy for cancer, including any other experimental treatment. b) Prior treatment with an anti-CTLA-4 antibody if treatment failure was due to irAEs. If a subject was discontinued from the prior anti-CTLA-4 treatment due to an AE or SAE, regardless of the type of event, that discontinuation constitutes an exclusion criterion. If irAEs were serious enough to require a subject's withdrawal from prior treatment, the subject should be excluded from this study. c) Prior treatment with chemotherapy/biochemotherapy/immunotherapy for systemic disease for melanoma (prior treatment with IFN-alpha immunotherapy is allowed)..
* Primary ocular and mucosal melanomas are not allowed.
* Medical History and Concurrent Diseases: a) Autoimmune disease: subjects with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease are excluded from this study as are subjects with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [eg, Wegener's Granulomatosis]). Subjects with motor neuropathy considered of autoimmune origin (eg, Guillain-Barre Syndrome and Myasthenia Gravis) are excluded from this study. b) Any subject who has a life-threatening condition that requires high-dose immunosuppressant(s). c) Presence of known HIV, hepatitis B or hepatitis C infection, regardless of control on antiviral therapy. d) Subjects with melanoma who have another active, concurrent, malignant disease with the exception of subjects with adequately treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix.
* Other Exclusion Criteria: a) Prisoners or subjects who are involuntarily incarcerated. b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. c) Any underlying medical or psychiatric condition that, in the opinion of the investigator, could make the administration of ipilimumab hazardous or could obscure the interpretation of adverse events. d) Any non-oncology vaccine therapy used for prevention of infectious diseases for up to 4 weeks before or after any dose of ipilimumab, with the exceptions of amantadine and flumadine.
* Any acute or chronic treatment with warfarin or anti-platelet agent (aspirin is allowed up to a dose of 300 mg daily) including clopidogrel. Heparin, low molecular weight heparin, any heparinoid are allowed after appropriate cessation (usually 24 hours prior to induction).
* Any known or suspected bleeding diathesis on the basis or personal or family history (including diagnoses of von Willebrands disease or other familial factor deficiency).
* The risk of the excision involves a significant risk of morbidity or mortality due to its size, location or vascularity (at the discretion of the principal investigators).
|
NCT_ID
NCT01715077
|
Study_NameStudy of Ipilimumab in the Immune System
| 21,472 |
Study Objectives
There is a great need for new therapies for carcinomas that have progressed on or not responded to current therapy. There are no approved Met targeted agents in standard clinical use. In the population of subjects with advanced carcinomas that are unresponsive to standard of care, and based on the relatively safe, reversible and monitorable toxicity profile of ASLAN002 in non clinical studies, the potential for benefit from ASLAN002 outweighs the potential risks for toxicity.
The purpose of this study is to identify the maximum tolerated dose of ASLAN002 in subjects with advanced or metastatic solid tumours, as well as to define the overall safety profile of ASLAN002.
Conditions: Malignant Solid Tumour
Intervention / Treatment:
DRUG: ASLAN002( BMS 777607)
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: BASIC_SCIENCE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Male or female subjects 18 years or older at the time of written informed consent is obtained
* Subjects with advanced or metastatic solid tumours who have either progressed on standard therapy or for whom standard therapy is not known
o Tumour paraffin tissue block or 6 <= age <= 10 unstained slides from the tissue block for biomarker analyses should be provided during screening, if available
* Subjects with histologic or cytologic diagnosis of the solid tumour (non-hematologic) malignancy
* Subjects with life expectancy of at least 2 months
* Subjects with prior anti-cancer treatments are permitted (i.e., chemotherapy, radiotherapy, hormonal, or immunotherapy
* Subjects with toxicity related to prior anti-cancer therapy and/or surgery must either have resolved, returned to baseline or deemed irreversible. Four (4) weeks must have elapsed between surgery and/or last dose of prior anti-cancer therapy and the initiation of study therapy. At least 6 weeks must have elapsed between prior therapy with nitrosoureas, mitomycin C, and liposomal doxorubicin. For biologics (e.g., monoclonal antibodies such as cetuximab) and extended-release formulations, the washout period must extend 1 month beyond the recommended dosing interval (e.g., for cetuximab, once per week + 1 month wash out)
* Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (within 28 days prior to enrolment)
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 3 months after the study in such a manner that the risk of pregnancy is minimized. WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Post menopausal is defined as:
* Amenorrhea >= 12 consecutive months without another cause or
* Irregular menstrual periods and on hormone replacement therapy (HRT), with a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotrophin [HCG]) within 72 hours prior to the start of investigational product (IP). Sexually active fertile men with partners of childbearing potential must use an approved barrier method of contraception while on study and until at least 3 months after the last dose of IP.
* Subjects with ability to comply with visits/procedures required by the protocol
* Subjects able to provide written informed consent before screening
Exclusion Criteria:
* Subjects unable to swallow or taken anything orally
* Subjects with significant underlying cardiac disease including ischaemic heart disease (New York Heart Association [NYHA] class III-IV severity) and prior myocardial infarction, or uncontrolled angina within 6 months of study entry
* Congestive cardiac failure within 3 months of study entry
* Documented prior history, or evidence of symptomatic orthostatic hypotension (e.g., orthostatic dizziness or light headedness) at screening
* Uncontrolled hypertension requiring treatment with calcium-channel antagonists or beta-blockers.
* Subjects requiring treatment for arrhythmias including atrial fibrillation, supraventricular tachycardia and previous episodes of ventricular tachycardia or fibrillation
* ECG abnormalities as confirmed by Holter monitoring Episodes of ventricular tachycardia or paroxysmal atrial fibrillation (to be reviewed by Principal Investigator and cardiologist)
* Subjects receiving beta-blockers, calcium-channel antagonists or Class IV anti-arrhythmic drugs including sotalol or amiodarone
* Subjects with known symptomatic brain metastasis. Subjects with controlled brain metastasis (no radiographic progression at least 4 weeks following radiation and/or surgical treatment and no neurological signs or symptoms) will be allowed.
* A serious uncontrolled medical disorder or active infection, which would impair the ability of the subject to receive protocol therapy.
* Current or recent (within 3 months) gastrointestinal disease that could impact the absorption of IP (i.e., unmanageable diarrhoea or malabsorption at the time of screening).
Inadequate laboratory findings:
Inadequate bone marrow function defined as:
Absolute neutrophil count < 1,500 cells/mm3 Platelet count < 100,000 cells/mm3 Haemoglobin < 9 g/dL Inadequate hepatic function Inadequate renal function Prothrombin time international normalized ration)/partial thromboplastin time > 1.5 times the ULN Serum sodium, potassium, calcium and magnesium levels equivalent to Grade 1 AE values as defined by Common Terminology Criteria for Adverse Events version 4.0
* Any atrophic macular condition including intermediate or advanced age-related macular degeneration
* Any gastrointestinal surgery that could impact upon the absorption of IP. Ablative surgery for gastroesophageal cancer (e.g., gastrectomy) will not be an automatic exclusion
* Any major surgery within 4 weeks of IP administration
* Inability to be veni-punctured and/or tolerate venous access
* History of allergy to ASLAN002 (BMS-777607) or chemically related compounds
Exclusion Criteria (cont'd):
* Prohibited treatments and/or therapies:
* Prior exposure to ASLAN002 (BMS-777607)
* Drugs that are generally accepted to have a risk of causing Torsade de Pointes, calcium channel blockers, beta blockers, and antiarrhythmic agents known to inhibit calcium ion channel currents. Subjects who have discontinued any of these medications must have a wash-out period of at least 5 days or at least 5 half-lives of the drug (whichever is longer) prior to the first dose of ASLAN002 (BMS-777607).
* Strong CYP2C8 substrates, proton pump inhibitors, and H-2 blockers. Subjects who have discontinued any of these medications must have a wash-out period of at least 5 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of ASLAN002 (BMS-777607).
* Exposure to any investigational drug or placebo within 4 weeks of enrollment
* Women with the following sexual and reproductive status:
* WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 3 months after the last dose of IP
* WOCBP using a prohibited contraceptive method (i.e., non-barrier methods)
* Women who are pregnant or breastfeeding
* Women with a positive pregnancy test on enrollment or prior to IP administration
* Sexually active fertile men not using effective birth control (e.g., barrier contraceptives) if their partners are WOCBP
* Prisoners or subjects who are involuntarily incarcerated
* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
* Any other sound medical, psychiatric, and/or social reasons as determined by the Investigator
|
NCT_ID
NCT01721148
|
Study_NameA Phase I Multiple Ascending Dose Study of ASLAN002 in Subjects With Advanced or Metastatic Solid Tumours
| 699 |
Study Objectives
People with pancreatic cancer usually have a large amount of the cancer in the area of the pancreas and around it when they are diagnosed with it. Or their cancer has spread (metastasized)outside that area of the abdomen and is not able to be surgically removed (resected). For patients with metastatic disease, one standard treatment is the combination of gemcitabine and erlotinib. This combination has shown slightly longer survival compared to getting gemcitabine alone. For patients with localized but unresectable disease, the standard treatment remains controversial. Early studies showed that chemotherapy and radiation together was better than either one used alone. The greatest benefit of external beam radiotherapy may be after a period of full-dose chemotherapy alone, to help the rapid spread. A problem of beginning treatment with standard radiotherapy is that the doses of chemotherapy usually have to be reduced sometimes by half.
Studies have already shown that low dose radiotherapy (LDRT)is safe. This study will evaluate the safety of LDRT instead of standard doses with full dosing of gemcitabine and erlotinib in patients with locally advanced or limited metastatic pancreatic cancer. Patients will be enrolled in groups of 3 to 6 each with a slightly higher dose of LDRT and erlotinib.
For patients with locally advanced disease, this protocol also may help because most patients develop and die from spread to the liver and abdominal cavity.
Conditions: Pancreatic Carcinoma Non-resectable, Metastatic Pancreatic Cancer
Intervention / Treatment:
DRUG: gemcitabine, DRUG: Erlotinib, RADIATION: low dose fractionated radiotherapy
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients must have a diagnosis of adenocarcinoma of the pancreas that is not amenable to curative surgical resection. Patients with locally advanced unresectable disease and those patients with metastatic disease that can be encompassed in the radiation fields for this study (as assessed by treating radiation oncologist) are eligible.
* Patients may not have received any prior chemotherapy for locally advanced or metastatic pancreatic cancer. Prior adjuvant chemotherapy completed >1 year previously is allowed.
* Patients must be able to provide informed consent and HIPAA consent.
* Patients must be >=18 years
* Adequate hematologic and organ function:
* ANC >= 1,000/μL, platelets >= 100,000/μL, hemoglobin >= 9.0/dL
* Bilirubin: <=1.5X ULN
* ALT/AST < 3.0 X upper limit of normal
* Serum Creatinine: WNL
* Albumin > 2.5 g/dL
* Measurable and non-measurable disease are permitted
* ECOG performance status 0 <= age <= 1
* Patients must be able to swallow oral medications
* Patients must be able to comply with study and follow up procedures
Exclusion Criteria:
* No prior radiation therapy to the abdomen.
* Patients must not have any other active illness (e.g. active/uncontrolled infection, uncontrolled cardiac disease, etc.) that would preclude safe therapy in the judgment of the treating physicians. Patients may be enrolled while still on antibiotics as long as clinical signs of active infection are absent.
* Patients with concurrent active malignancy requiring therapy are not eligible. Patients with a history of malignancy within any timeframe not requiring ongoing therapy are eligible.
|
NCT_ID
NCT00761345
|
Study_NameStudy of Low-Dose Fractionated Radiotherapy in Patients With Locally Advanced Metastatic Pancreatic Cancer
| 22,373 |
Study Objectives
A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.
Conditions: Carcinoma, Renal Cell
Intervention / Treatment:
DRUG: Sunitinib malate
Location: Brazil, Australia, Taiwan, Korea, Republic of, Mexico, Argentina
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Advanced kidney cancer
Exclusion Criteria:
* Previous treatment for kidney cancer, except surgical removal of kidney tumor
|
NCT_ID
NCT00338884
|
Study_NameSafety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer
| 16,990 |
Study Objectives
This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.
Conditions: Hodgkin Disease, Peripheral T Cell Lymphoma
Intervention / Treatment:
DRUG: brentuximab vedotin, DRUG: bendamustine, DRUG: dacarbazine, DRUG: nivolumab
Location: Canada, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Parts A, B, C, and D: 60 years or older
* Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
* Treatment-naive patients with CD30-expressing PTCL (Part F)
* Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
* Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by:
* A CIRS score of 10 or greater
* Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs)
* Measurable disease of at least 1.5 cm as documented by radiographic technique
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)
Exclusion Criteria:
* Symptomatic neurologic disease compromising IADLs or requiring medication
* History of progressive multifocal leukoencephalopathy
* Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin
* Concurrent use of other investigational agents
* Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
* History of another malignancy within 1 year before first dose of study drug (Parts E and F only)
* Part D only:
* Received any prior immune-oncology therapy
* History of known or suspected autoimmune disease
* Prior allogeneic stem cell transplant
* History of cerebral vascular event within 6 months of first dose of study drug
* Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology
* Known history of pancreatitis
* Parts D, E, and F only:
* Known cerebral/meningeal disease related to the underlying malignancy
* Systemic treatment with corticosteroids or other immunosuppressive medications within 1 week of enrollment
|
NCT_ID
NCT01716806
|
Study_NameA Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)
| 12,468 |
Study Objectives
Evaluation of the histologically proven adenoma and carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets.
Conditions: Colorectal Cancer
Intervention / Treatment:
DRUG: Methylene Blue MMX®, DRUG: Placebo
Location: Germany, United States, United Kingdom, Italy, Netherlands, Lithuania, Belgium, Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: SCREENING
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Males or females, aged between 50 and 75.
* Outpatients scheduled for screening or surveillance colonoscopy for polyps or colorectal cancer )
* Able to comprehend the full nature and purpose of the study, including possible risks and side effects.
* Able to co-operate with the investigator and to comply with the requirements of the entire study.
* Signed written informed consent prior to inclusion in the study.
Exclusion Criteria:
* Patients at high risk of colorectal cancer e.g. ulcerative colitis
* Previous medical history of, or suspected hypersensitivity to, the Methylene Blue and/or formulations' ingredients.
* Previous medical history of, or suspected hypersensitivity to, the PEG based bowel cleansing preparation and/or bowel cleansing formulations' ingredients.
* Previous medical history of gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, severe diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, ulcerative colitis or Crohn's disease.
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NCT_ID
NCT01694966
|
Study_NameThe Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
| 301 |
Study Objectives
The human body has a natural stress response to surgery, including the formation of blood clots. This response to surgery has been shown to increase metastases (the spread of cancer cells to other organs in the body). These metastases cannot be seen at the time of surgery but when they grow into new tumors, the cancer has recurred (come back). A blood thinner called "low molecular weight heparin" (LMWH) can suppress the development of metastases after surgery in animal experiments. The investigators want to see if giving patients with colorectal cancer the blood thinner, LMWH, around the time of surgery can decrease the chance of their cancer spreading to other organs (metastases) and coming back (recurrence).
The investigators need 1075 patients to answer our scientific question. Patients who give informed consent will be randomly put into one of two groups, the experimental group and the control group. The patients in the control group will be treated with LMWH starting a few hours after surgery and every day until they leave the hospital. This is how most patients are treated after colon cancer surgery (standard care). The patients in the experimental group will be treated with LMWH for a longer period of time, starting on the day they agree to have surgery and continuing for two months after surgery. All the patients will be followed for at least three years after surgery to find out if their cancer has recurred (come back). If LMWH treatment around the time of surgery reduces the chance of recurrence in patients with colorectal cancer, it would improve the health and quality of life for these patients.
Conditions: Adenocarcinoma of the Colon
Intervention / Treatment:
DRUG: Tinzaparin, DRUG: Tinzaparin
Location: Belgium, Canada, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Diagnosis of pathologically-confirmed invasive adenocarcinoma of the colon or rectum
* Pre-operative work-up that reveals potential resectability (CT scan or MRI of the abdomen and pelvis) with resection planned within 6 weeks of date of randomization
* Pre-operative work-up that reveals no evidence of metastatic disease (CT scan or MRI of the abdomen and pelvis and chest X-ray (CXR) or CT scan of the chest)
* Age >=18 years
* Hemoglobin >= 80g/L
* Able and willing to comply with study procedures and follow-up examinations contained within the written consent form.
Exclusion Criteria:
* Carcinoma only present in a completely excised polyp (i.e. no residual tumour evident in the colon)
* Prior VTE including deep vein thrombosis (DVT) or pulmonary embolism (PE)
* Requirement for full dose peri-operative anticoagulation
* Contraindication to heparin therapy
1. history of heparin induced thrombocytopenia (HIT)
2. platelet count of less than 100 x 109/L
3. actively bleeding
4. severe hypertension (SBP >200 and/or DBP >120) on more than one reading
5. documented peptic ulcer within 6 weeks
6. severe hepatic failure (INR >1.8)
7. creatinine clearance of < 30 ml/min as calculated by the Cockcroft-Gault formula
8. Other contraindication to anticoagulation
* Participating in another interventional trial that may result in co-intervention or contamination (to be determined by sponsor)
* History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years of the colorectal cancer diagnosis
* Pregnant or lactating
* Unable/unwilling to providing informed consent.
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NCT_ID
NCT01455831
|
Study_NameExtended Peri-operative Tinzaparin to Improve Disease-free Survival in Patients With Resectable Colorectal Cancer
| 3,420 |
Study Objectives
The purpose of the this study is to evaluate the effect of a high-fat, high calorie meal on the single dose PK of GSK1120212 in subjects with solid tumors.
Conditions: Cancer
Intervention / Treatment:
DRUG: GSK1120212
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE
|
Inclusion Criteria:
* A subject will be eligible for inclusion in this study only if all of the following criteria apply:
1. Male or female; 18 years or older at the time of consent
2. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
3. Able to swallow and retain oral medication.
4. Histologically or cytologically confirmed diagnosis of a solid tumor.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 3).
6. Adequate baseline organ function defined in Table 5 Definitions for Adequate Baseline Organ Function Absolute neutrophil count greater than or equal to 1.2 × 109/L Hemoglobin greater than or equal to9 g/dL Platelets greater than or equal to 75 × 109/L Prothrombin time (PT), International normalization ratio (INR)a and Partial thromboplastin time (PTT) less than or equal to 1.5 times ULN Hepatic Total bilirubin less than or equal to 1.5 times ULN ALT less than or equal to 2.5 times ULN Renal Creatinine or less than or equal to 1.5 times ULN Calculated creatinine clearance or greater than or equal to 50 mL/min 24-hour urine creatinine clearance greater than or equal to 50 mL/min Cardiac LVEF greater than or equal to LLNc by ECHO or MUGA
1. INR greater than 1.5 times ULN will be acceptable in case of subjects receiving therapeutic anticoagulants such as warfarin as long as INR is monitored during the study according to clinical practice.
2. Calculated by the Cockcroft-Gault formula (see Appendix 2).
3. If LLN is not defined for a given institution, then ejection fraction must be greater than or equal to 50%.
7. Women of childbearing potential must have a negative serum pregnancy test within 14 days of first dose of study treatment and agree to use effective contraception, as defined in Section 7.1.1, during the study and for 6 weeks following the last dose of study treatment.
8. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception as described in Section 7.1.2 from the time of the first dose of study treatment until 16 weeks following the last dose of study treatment (based on the lifecycle of sperm).
Exclusion Criteria:
* A subject will not be eligible for inclusion in this study if any of the following criteria apply:
1. Currently receiving cancer therapy (e.g., chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or major surgery) within 3 weeks prior to randomization; chemotherapy regimens without delayed toxicity within 2 weeks prior to randomization; or use of an investigational anti-cancer drug within 4 weeks prior to randomization.
2. Has unresolved Grade 2 or greater toxicity (based on NCI-CTCAE, version 4.0) [NCI Common Terminology Criteria for Adverse Events, 2009] from previous anti-cancer therapy except Grade 2 decreased hemoglobin levels or alopecia.
3. Has pre-existing peripheral neuropathy of greater than or equal to Grade 2.
4. Has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product, whichever is longer, prior to the first dose of study treatment in this study.
5. Has participated in a study that resulted in or made a donation of blood or blood products in excess of 500 mL within 56 days of the first dose of study treatment.
6. Has presence of active GI disease or other condition (e.g., gastrectomy, bariatric surgery, small or large bowel resection, or cholecystectomy should be excluded) that may interfere significantly with the absorption of drugs. If clarification is needed as to whether a condition will significantly affect absorption of drugs, contact the GSK Medical Monitor.
7. Has any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor.
8. Has a history of interstitial lung disease or pneumonitis.
9. Is currently using a prohibited medication(s) or requires the use of any of the prohibited medications during the study (see Section 8.2).
* NOTE: Use of anticoagulants such as warfarin is permitted; however, INR must be monitored in accordance with local institutional practice.
10. Has a history or current evidence/risk of RVO or CSR:
* History of RVO or CSR, or predisposing factors to RVO or CSR (i.e., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension or diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes)
* Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as:
* Evidence of new optic disc cupping
* Intraocular pressure greater than 21 mmHg as measured by tonography
11. Has symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression
* Note: Subjects previously treated for these conditions that have had stable central nervous system (CNS) disease (verified with consecutive imaging studies) for greater than 3 months, are asymptomatic and are not currently taking corticosteroids, or are on stable dose of corticosteroids for at least 1 month prior to Day 1 of the study are permitted.
* Subjects are not permitted to receive enzyme-inducing anti-epileptic drugs (EIAEDs).
12. Has a QtcB or QTcF (preferred) greater than or equal to 480 msec.
13. Has a history or evidence of cardiovascular risk including any of the following:
14. History or evidence of current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation for greater 30 days prior to randomization are eligible.
15. History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization.
16. History or evidence of current greater than or equal to Class II congestive heart failure as defined by New York Heart Association (NYHA) (Appendix 4).
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NCT_ID
NCT01371487
|
Study_NameGSK1120212 Food-effect Study
| 18,711 |
Study Objectives
The purpose of this study is to determine the safety of lenalidomide and markers for disease progression in the treatment of IPSS low- or intermediate-1 risk MDS with isolated del5q.
Conditions: Myelodysplastic Syndromes
Intervention / Treatment:
DRUG: Lenalidomide
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Must understand and voluntarily sign an informed consent form
* Age >= 18 years at the time of signing the informed consent form.
* Must be able to adhere to the study visit schedule and other protocol requirements
* Cytologically/histologically confirmed diagnosis of MDS with del 5q (isolated, blast count <5%), IPSS low or intermediate-1.
* Transfusion dependency with at least 1 concentrates of erythrocytes within 8 weeks prior to first administration of study drug.
* Start of treatment with lenalidomide is the best therapeutic option for the patient according to the investigator's assessment There are - apart from individual cases with erythropoetin level lower than 500 U/l and allogeneic transplantation for younger patients - no authorized alternative treatment options. Chemotherapy with low dose cytosine arabinoside may result in hematologic improvement. However, concerning the risk-benefit-assessment this chemotherapy is more unfavorable than lenalidomide due to cytopenia and mutagenic effects.
* Female subjects of childbearing potential must:
* Understand that the study medication has a teratogenic risk
* Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception*: (Implant,Levonorgestrel-releasing intrauterine system (IUS)**,Medroxyprogesterone acetate depot, Tubal sterilisation, Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses, Ovulation inhibitory progesterone-only pills (i.e., desogestrel))
* Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days before the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
* Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
(*) Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception.
(**) Prophylactic antibiotics should be considered at the time of insertion particularly in patients with neutropenia due to risk of infection
* Male subjects must
* Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.
* Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
* All subjects must
* Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
* Agree not to share study medication with another person and to return all unused study drug to the investigator
Exclusion Criteria:
* Pregnant or lactating females
* IPSS intermediate-2 or high-risk
* Proliferative (WBC >= 12 x 109/L) CMML
* Any of the following laboratory abnormalities:
* Absolute neutrophil count (ANC) < 1 x 109/L
* Platelet count < 50 x 109/L
* Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 3.0 x upper limit of normal (ULN)
* Serum total bilirubin > 1.5 mg/dL Degree of severity of anemia is no exclusion criteria due to intensive interindividual variations of the haemoglobin value at time of transfusion.
* Prior >= grade-2 NCI CTCAE allergic reaction to thalidomide
* Prior desquamating (blistering) rash while taking thalidomide
* Neuropathy >= grade 2
* Clinically significant anemia owing to iron, B12, or folate deficiencies, or autoimmune or hereditary hemolysis or gastrointestinal bleeding (the subject must have a marrow aspirate that is evaluable for storage iron)
* Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for >= 3 years
* Concomitant use of androgens (exception: treatment of hypogonadism)
* Concomitant use of specific treatments for MDS
* Known HIV-1 positivity
* Participation in another clinical study in the 4 weeks prior to enrollment or during this study
* Prior treatment with lenalidomide
* Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he/she participates in the study.
|
NCT_ID
NCT01081431
|
Study_NameSafety of Lenalidomide and Markers for Disease Progression in Patients With International Prognostic Scoring System (IPSS) Low- or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) With Isolated del5q
| 1,060 |
Study Objectives
To assess the efficacy and safety of gemcitabine given by fixed dose rate intravenous infusion in patients with pretreated metastatic colorectal cancer.
Conditions: Colorectal Cancer
Intervention / Treatment:
DRUG: Gemcitabine
Location: United Kingdom
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Age >18 years
* Histologically proven colorectal adenocarcinoma.
* Locally advanced (inoperable) or metastatic colorectal carcinoma treated with at least one prior chemotherapy regimen.
* Progressive disease documented by CT either during or within 3 months of completion of previous chemotherapy
* No previous malignant disease other than non-melanotic skin cancer or carcinoma-in-situ of the uterine cervix.
* Unidimensional measurable disease as assessed by CT.
* Adequate bone marrow function; Hb >10g/dl, platelets >100 x109/l, WBC >3x109/l, Neut >1.5x109/l.
* Adequate liver function: Serum Bilirubin <1.5 x upper limit of normal
* Adequate renal function: Serum Creatinine < 0.11 mmol/L
* No concurrent uncontrolled medical conditions
* WHO performance status 0,1 or 2
* Adequate contraceptive precautions, if appropriate
* Informed written consent
* Negative pregnancy test in women of child bearing age
* Life expectancy > 3 months
Exclusion Criteria:
* Medical or psychiatric condition that comprise the patient's ability to take informed consent.
* Patients within 4 weeks of chemotherapy or radiotherapy (6 weeks for nitrosureas or mitomycin C).
* Previous treatment with gemcitabine.
* Patients with uncontrolled cerebral metastases.
|
NCT_ID
NCT00220155
|
Study_NamePhase II Fixed Dose Rate Gemcitabine for Advanced or Metastatic Colorectal Cancer
| 14,434 |
Study Objectives
This phase III trial is studying observation to see how well a risk based treatment strategy works in patients with soft tissue sarcoma. In the study, patients are assigned to receive surgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
Conditions: Adult Alveolar Soft-part Sarcoma, Adult Angiosarcoma, Adult Epithelioid Sarcoma, Adult Extraskeletal Chondrosarcoma, Adult Extraskeletal Osteosarcoma, Adult Fibrosarcoma, Adult Leiomyosarcoma, Adult Liposarcoma, Adult Malignant Fibrous Histiocytoma, Adult Malignant Hemangiopericytoma, Adult Malignant Mesenchymoma, Adult Neurofibrosarcoma, Adult Synovial Sarcoma, Childhood Alveolar Soft-part Sarcoma, Childhood Angiosarcoma, Childhood Epithelioid Sarcoma, Childhood Fibrosarcoma, Childhood Leiomyosarcoma, Childhood Liposarcoma, Childhood Malignant Mesenchymoma, Childhood Neurofibrosarcoma, Childhood Synovial Sarcoma, Dermatofibrosarcoma Protuberans, Metastatic Childhood Soft Tissue Sarcoma, Nonmetastatic Childhood Soft Tissue Sarcoma, Stage I Adult Soft Tissue Sarcoma, Stage II Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma
Intervention / Treatment:
DRUG: doxorubicin hydrochloride, OTHER: clinical observation, PROCEDURE: therapeutic conventional surgery, RADIATION: 3-dimensional conformal radiation therapy, DRUG: ifosfamide
Location: United States, Australia, Puerto Rico, Canada, New Zealand
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Newly diagnosed non-rhabdomyosarcoma soft tissue sarcoma (STS), confirmed by central pathology review via concurrent enrollment on protocol COG-D9902
* Metastatic or non metastatic disease
* Meets 1 of the following criteria:
* Intermediate (i.e., rarely metastasizing) or malignant STS, including any of the following:
* Adipocytic tumor, including liposarcoma of any of the following histology subtypes:
* Dedifferentiated
* Myxoid
* Round cell
* Pleomorphic type
* Mixed-type
* Not otherwise specified (NOS)
* Fibroblastic/myofibroblastic tumors, including any of the following:
* Solitary fibrous tumor
* Hemangiopericytoma
* Low-grade myofibroblastic sarcoma
* Myxoinflammatory fibroblastic sarcoma
* Adult fibrosarcoma*
* Myxofibrosarcoma
* Low-grade fibromyxoid sarcoma or hyalinizing spindle-cell tumor
* Sclerosing epithelioid fibrosarcoma
* So-called fibrohistiocytic tumors, including any of the following:
* Plexiform fibrohistiocytic tumor
* Giant cell tumor of soft tissues
* Pleomorphic malignant fibrous histiocytoma (MFH)/undifferentiated pleomorphic sarcoma
* Giant cell MFH/undifferentiated pleomorphic sarcoma with giant cells
* Inflammatory MFH/undifferentiated pleomorphic sarcoma with prominent inflammation
* Smooth muscle tumor (leiomyosarcoma)
* Pericytic [perivascular] tumor (malignant glomus tumor or glomangiosarcoma)
* Vascular tumor, including angiosarcoma
* Chondro-osseous tumors of any of the following types:
* Mesenchymal chondrosarcoma
* Extraskeletal osteosarcoma
* Tumors of uncertain differentiation, including any of the following:
* Angiomatoid fibrous histiocytoma
* Ossifying fibromyxoid tumor
* Myoepithelioma/parachordoma
* Synovial sarcoma
* Epithelioid sarcoma
* Alveolar soft-part sarcoma
* Clear cell sarcoma of soft tissue
* Extraskeletal myxoid chondrosarcoma ("chordoid type")
* Malignant mesenchymoma
* Neoplasms with perivascular epithelioid cell differentiation (PEComa)
* Clear cell myomelanocytic tumor
* Intimal sarcoma
* Malignant peripheral nerve sheath tumor
* Dermatofibrosarcoma protuberans meeting both of the following criteria:
* Non metastatic disease
* Tumor must be grossly resected prior to study enrollment
* Embryonal sarcoma of the liver
* Unclassified STS that is too undifferentiated to be placed in a specific pathologic category (undifferentiated STS or STS NOS)
* Gross resection of the primary tumor <= 42 days prior to enrollment required except if any of the following circumstances apply:
* Non metastatic high-grade tumor > 5 cm in maximal diameter and gross or microscopic residual tumor is anticipated after resection
* Tumor of either high- or- low-grade that cannot be grossly excised without unacceptable morbidity
* High-grade tumor with metastases
* Patients with metastatic low-grade tumor whose disease is amenable to gross resection at all sites must undergo gross resection of all sites prior to study entry
* Patients with a tumor recurrence after a gross total resection are not eligible
* Tumors arising in bone are not eligible
* Patients with epithelioid sarcoma, clear cell sarcoma, or clinical or radiologic evidence of regional lymph node enlargement must undergo sentinel lymph node biopsies or lymph node sampling to confirm the status of regional lymph nodes* NOTE: *Except in cases where the study radiologist reviews the imaging and indicates that a biopsy is not needed to confirm that the patient has lymph node involvement.
* If lymph node biopsies are positive for tumor (or the lymph nodes are classified as positive by the study radiologist), formal lymph node dissection must be done at the time of definitive surgery(prior to study entry for patients assigned to study regimen C)
* Patients with metastatic disease must undergo a biopsy to confirm the presence of metastatic tumor if all metastases are < 1 cm in maximal diameter (except in cases where the study radiologist reviews the imaging and indicated that a biopsy is not needed to confirm that the patient has metastatic disease)
* Lansky performance status (PS) 50 <= age <= 100% (for patients <= 16 years) OR Karnofsky PS 50 <= age <= 100% (for patients > 16 years)
* Life expectancy >= 3 months
* Absolute neutrophil count >= 1,000/mm³*
* Platelet count >= 100,000/mm³*
* Creatinine clearance or radioisotope glomerular filtration rate >= 70 mL/min (>= 40 mL/min for infants < 1 year of age)* or serum creatinine based on age and/or gender as follows:
* 0.4 mg/dL (1 month to < 6 months of age)
* 0.5 mg/dL (6 months to < 1 year of age)
* 0.6 mg/dL (1 year to < 2 years)
* 0.8 mg/dL (2 years to < 6 years)
* 1.0 mg/dL (6 years to < 10 years)
* 1.2 mg/dL (10 years to < 13 years)
* 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 years to < 16 years)
* 1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years)
* Patients with urinary tract obstruction by tumor must meet the renal function criteria listed above AND must have unimpeded urinary flow established via decompression of the obstructed portion of the urinary tract
* Bilirubin <= 1.5 times upper limit of normal (ULN)*
* Shortening fraction >= 27% by echocardiogram* OR ejection fraction >= 50% by radionuclide angiogram*
* Not pregnant or nursing (patients undergoing radiotherapy and/or chemotherapy)
* No nursing for >= 1 month after completion of study treatment in study regimens C or D
* Fertile patients must use effective contraception during and for >= 1 month after completion of study treatment
* Negative pregnancy test
* No evidence of dyspnea at rest*
* No exercise intolerance*
* Resting pulse oximetry reading > 94% on room air (for patients with respiratory symptoms)*
* Prior treatment for cancer allowed provided the patient meet the prior therapy requirements
* No prior anthracycline (e.g., doxorubicin or daunorubicin) or ifosfamide chemotherapy for patients enrolled on arm C or arm D
* No prior radiotherapy to tumor-involved sites
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NCT_ID
NCT00346164
|
Study_NameObservation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma
| 10,757 |
Study Objectives
The purpose of this study is to determine the safety and efficacy of TLK199 Tablets in patients with Myelodysplastic Syndrome (MDS)
Conditions: Myelodysplastic Syndrome (MDS)
Intervention / Treatment:
DRUG: Ezatiostat Hydrochlorine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histologically confirmed diagnosis of MDS
* Documented significant cytopenia for at least 2 months
* Adequate liver and kidney function
* Ineligible for stem cell bone marrow transplantation
* At least 18 years
* Discontinuation of growth factors (e.g., G-CSF) within 3 weeks of study entry
Exclusion Criteria:
* Prior bone marrow transplant
* Failure to recover from any prior surgery or any major surgery within 4 weeks of study entry
* Pregnant or lactating women
* Other investigational drugs within 14 days of study entry
* Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry
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NCT_ID
NCT00280631
|
Study_NameStudy of TLK199 Tablets in Myelodysplastic Syndrome (MDS)
| 3,444 |
Study Objectives
Polycystic Ovary Syndrome (PCOS) is characterized by hyperandrogenism, ovulatory dysfunction and polycystic ovaries. Insulin resistance (IR) is a common feature of PCOS, and the resultant hyperinsulinemia is theorized to promote hyperandrogenism in the disorder. However, 30-50% of women with PCOS who are lean do not have insulin resistance. Women with PCOS also exhibit chronic low-grade inflammation. In PCOS, glucose ingestion activates nuclear factor ĸB (NFĸB), the cardinal signal of inflammation culminating in upregulation of the inflammation pathway within mononuclear cells (MNC). This phenomenon is independent of excess adiposity and is highly correlated with circulating androgens. In addition, in vitro exposure to proinflammatory stimuli is capable of directly stimulating ovarian theca cell androgen production. Nonacetylated salicylates suppress NFĸB activation and are well tolerated in humans.
The proposed research is a randomized double-blind placebo-controlled study of 90 women with PCOS. Forty-five subjects with PCOS (15 lean without IR), 15 lean with IR and 15 obese) receiving salsalate, a nonacetylated salicylate, at an oral dose of 3-4 gm daily for 12 weeks will be compared with 45 age- and body-composition-matched control women with PCOS receiving placebo. The overarching hypothesis is that inflammation contributes to ovarian dysfunction, independent of excess adiposity or IR.
The specific aims are, I: To examine the effect of salsalate administration on the ovarian capacity to secrete androgen and on insulin sensitivity in PCOS. II: To examine the effect of salsalate administration on the inflammatory response of mononuclear cells induced by lipid ingestion and glucose infusion in PCOS. The approach involves evaluation of ovarian androgen secretion in response to human chorionic gonadotropin (HCG) administration and insulin sensitivity during the euglycemic phase of a two-step pancreatic clamp along with ovulation monitoring before and after salsalate administration. The inflammatory response of MNC to lipid ingestion and the hyperglycemic phase of the two-step clamp will also be evaluated during treatment by measuring reactive oxygen species, the mRNA and protein content of inflammation markers, NFĸB activation and cytokine release in culture.
The investigators expect that women with PCOS receiving salsalate will exhibit decreased ovarian androgen secretion and reduced inflammation regardless of adiposity or IR status. These results will be significant if they show a causal contribution of inflammation to ovarian dysfunction in PCOS, thus improving our understanding of the pathogenesis of PCOS, opening previously unexplored therapeutic avenues that are not necessarily dependent on improving IR, and guiding the design of future studies aimed at determining what interventions will optimally attenuate inflammation in PCOS to reduce medical disease and enhance fertility.
Conditions: Polycystic Ovary Syndrome
Intervention / Treatment:
DRUG: Salsalate, OTHER: Placebo
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: BASIC_SCIENCE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria:
* Diagnosis of PCOS based on the presence of hyperandrogenism (skin manifestations of androgen excess such as hirsutism, acne or temporal balding - or -elevation of at least one serum androgen [i.e. total testosterone, free testosterone, androstenedione or dehydroepiandrosterone-sulphate] using predetermined local laboratory cutoffs), oligo/amenorrhea and evidence of withdrawal bleeding after progestin administration.
* 18 <= age <= 40 years.
* Good health as evidenced by medical history, physical examination and gynecologic examination within 30 days prior to starting the study.
* Willingness to provide informed consent according to the guidelines of the University of Illinois at Chicago (UIC) Institutional Review Board (IRB).
* Willingness to use double-barrier contraception such as condoms and topical spermicide (foam, cream or gel), condom and diaphragm, diaphragm and topical spermicide or sponge with topical spermicide if sexually active. Use of a non-hormonal intrauterine device (IUD), or permanent sterilization of the subject or her partner (i.e. tubal ligation or vasectomy) is also acceptable in all instances.
Exclusion Criteria:
* Hyperprolactinemia.
* Uncontrolled thyroid disease.
* Evidence of Cushing's syndrome, nonclassic congenital adrenal hyperplasia or a hormone producing tumor based on physical findings and serum androgen levels on initial screening.
* Known or suspected pregnancy.
* Regular vigorous physical activity during previous 6 months.
* Use of any medications known to affect carbohydrate or sex hormone metabolism such as oral contraceptives, progestins, glucocorticoids or insulin sensitizing agents within 30 days of beginning the study.
* Acute or chronic inflammatory illnesses (e.g. upper respiratory infection, asthma, rheumatoid arthritis or systemic lupus erythematosus).
* Type 1 or type 2 diabetes mellitus defined as having a fasting glucose >126 mg/dl and/or a 2-hour postprandial glucose >200 mg/dl.
* Regular smoking defined as more than 2 cigarettes a month, or any smoking within 30 days of beginning the study.
* History of any illness exacerbated by salicylate use (e.g. peptic ulcer hepatic or renal disease, anemia, thrombosis, coagulopathy, congestive heart failure, hypertension or gout).
* Allergy to salicylate or dairy products.
* Medication use interacting with salicylates such as anti-platelet drugs (e.g. cilostazol, clopidogrel), anticoagulants (e.g. enoxaparin, heparin, warfarin), corticosteroids (e.g., prednisone), certain diabetes drugs (e.g. sulfonylureas such as glyburide), certain anti-seizure drugs (e.g. phenytoin, valproic acid), cidofovir, cyclosporine, drugs for gout (e.g. probenecid, sulfinpyrazone), anti-hypertensives (e.g. angiotensin converting enzyme inhibitors such as captopril, angiotensin II receptor antagonists such as losartan, and beta blockers such as metoprolol), drugs that affect the acidity of urine (e.g. ammonium chloride, acetazolamide), lithium, methotrexate, oral bisphosphonates (e.g. alendronate), pemetrexed, selective serotonin reuptake inhibitor antidepressants (e.g. fluoxetine, sertraline), tenofovir, and diuretics (furosemide, hydrochlorothiazide, spironolactone).
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NCT_ID
NCT03229408
|
Study_NameTreating Inflammation in Polycystic Ovary Syndrome to Ameliorate Ovarian Dysfunction
| 17,453 |
Study Objectives
The goal of this clinical research study is to find the highest tolerable dose of the combination of oxaliplatin and capecitabine with or without bevacizumab that can be given to patients with advanced cancer that has spread to the liver. The safety of these drug combinations will also be studied.
Conditions: Advanced Cancers
Intervention / Treatment:
DRUG: Oxaliplatin, DRUG: Capecitabine, DRUG: Bevacizumab
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients must have histologically confirmed cancer with predominant liver metastases.
* Performance status Eastern Cooperative Oncology Group (ECOG) 0 <= age <= 2 (capable of all self care but unable to carry out any work activities).
* Adequate renal function (creatinine clearance >50 mL/min).
* Adequate liver function: total bilirubin <= 4 mg/dL, alanine transaminase (ALT) <= 5 times upper normal reference value. Patients with total bilirubin between 3.0 and 4.0 mg/dL must have blood ammonia level checked at baseline. Blood ammonia level must be within normal limits for enrollment.
* Adequate bone marrow function (absolute neutrophil count (ANC) >= 1000 cells/uL; platelets (PLT) >= 70,000 cells/uL).
* At least 3 weeks from prior cytotoxic chemotherapy or radiation therapy. If targeted or biologic therapy, there should be at least 5 half lives or 3 weeks, whichever is shorter, from day 1 of treatment.
* All females in childbearing age MUST have a negative urine human chorionic gonadotropin (HCG) test before the first dose, unless prior hysterectomy or menopause (defined as age above 55 and six months without menstrual activity). Patients should not become pregnant or breast-feed while on this study. Sexually active patients should use effective birth control.
* Ability and willingness to sign informed consent form.
* Must be >= 18 years.
* Patients with unresectable liver-only (isolated liver) metastases are eligible; those who show adequate response may be considered for liver resection and/or radiofrequency ablation (RFA) of remaining disease.
Exclusion Criteria:
* Pregnant females.
* Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
* Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection requiring parental antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients already in uncompensated liver failure (i.e., Child Pugh Liver Classification C).
* History of hypersensitivity to any component of the formulation.
* Exclusion criteria only for patients enrolled in Arm 1: Serious or non-healing wound, ulcer, or bone fracture.
* Exclusion criteria only for patients enrolled in Arm 1: Any history of abdominal fistula or gastrointestinal perforation; or intra-abdominal abscess within 28 days of enrollment.
* Exclusion criteria only for patients enrolled in Arm 1: Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mm Hg, diastolic Blood Pressure > 90 mm Hg).
* Exclusion criteria only for patients enrolled in Arm 1: History of bleeding CNS metastases.
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NCT_ID
NCT01213238
|
Study_NameHepatic Arterial Infusion Oxaliplatin, Capecitabine With or Without Bevacizumab
| 10,716 |
Study Objectives
Patients with pilonidal sinus disease will be randomised to two groups (crystallised phenol and platelet rich plasma). Sinus healing time, patient satisfaction, complications and recurrence rates will be compared.
Conditions: Pilonidal Sinus
Intervention / Treatment:
PROCEDURE: crystallised phenol, PROCEDURE: Platelet rich plasma
Location: Turkey
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE
|
Inclusion Criteria:
* Having pilonidal sinus disease
* accepting to be involved in the study
Exclusion Criteria:
* below the age of 18
* having connective tissue disorders
* diabetes mellitus
* severe anemia
|
NCT_ID
NCT03070028
|
Study_NameMinimally Invasive Treatment Methods for Pilonidal Disease
| 18,589 |
Study Objectives
This study will examine an investigational (experimental) treatment using gemcitabine, cisplatin, and celecoxib. Preliminary studies have shown that this experimental treatment may be effective in reducing the size of cancerous tumors and/or preventing further tumor growth.
This is a phase II clinical trial studying the reactions of the patient's body and their tumor to the combination of gemcitabine, cisplatin, and celecoxib. The purpose of this study is to see if the tumor responds to this treatment and to determine how long the response lasts. This study will also look at what kind of side effects this experimental treatment causes and see how often these side effects occur. Blood levels of celecoxib will be measured to find out how this treatment affects factors (proteins) involved in new blood vessel formation and tumor growth (angiogenesis).
Conditions: Pancreatic Cancer
Intervention / Treatment:
DRUG: Gemcitabine, DRUG: Cisplatin, DRUG: Celecoxib
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria
* Patients must have histologic or cytologic diagnosis of pancreatic adenocarcinoma.
* Patients must have clinical/radiologic evidence of metastatic disease (stage IV).
* Patients must not have received prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy is allowed, provided that the last day of therapy was at least 6 months prior to starting treatment.
* Patients must have performance status of 0 <= age <= 2 on the SWOG scale.
* Patients must have an estimated life expectancy of at least 12 weeks.
* Patients must have adequate bone marrow function: absolute neutrophil count >1,500/cmm, platelet count >100,000/cmm.
* Patients must be informed of the investigational nature of this study and must give written informed consent prior to the receiving of treatment per this protocol.
* Patients must practice effective birth control while receiving treatment.
Exclusion Criteria
* Patients with endocrine tumors or lymphoma of the pancreas.
* Patients with locally advanced pancreatic cancer.
* Patients with a proven history (radiographic and/or endoscopic) of peptic ulcer or esophageal erosions within one year of enrollment onto the study.
* Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs.
* History of active central nervous system (CNS) metastases.
* Inadequate liver function (bilirubin >3.0 mg/dL); transaminases (AST/ALT) >3 times upper limit of institutional normal.
* Inadequate renal function (creatinine >1.5 mg/dL).
* Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
* History of other malignancy, except for cancers that have been treated with a curative intent and patient is without evidence of active disease.
* Unresolved bacterial infection requiring treatment with antibiotics.
* Pregnant or lactating women may not participate in the study.
* Patients who have allergy to any of the study drugs or sulfa drugs.
* Patients infected with HIV-1 virus because of the undetermined effect of this chemotherapy regimen in patients with HIV-1 and the potential for serious interaction with anti-HIV medications.
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NCT_ID
NCT00176813
|
Study_NameGemcitabine, Cisplatin, and Celecoxib Treatment of Metastatic Pancreatic Cancer
| 8,208 |
Study Objectives
This is a prospective Phase II, monocentre study.
Conditions: Children Cancer, Solid Tumor
Intervention / Treatment:
DRUG: Plerixafor, mozobil
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* 0 <= age <= 18 old
* Solid malign tumor
* Lansky score >= 70%
* Indication of hematopoietic stem cell taking by cytapheresis for extensive chemotherapy followed by one or several reinjections of hematopoietic stem cells
Exclusion Criteria:
* Administration of hematopoietic growth factors in 8 days preceding the injection of Plerixafor.
* Contraindication in the cytapheresis or in the extensive chemotherapy.
* Clinical or biological state dissuading the realization of the cytapheresis
* Chemotherapy in 15 days preceding the injection of plerixafor or neutrophils < 1500/mm3
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NCT_ID
NCT01225419
|
Study_NameMobilization by Plerixafor of Haematopoietic Stem Cells in Children
| 7,679 |
Study Objectives
A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Methyl aminolevulinate hydrochloride (MAL) 16.8% cream (CD06809-41) versus vehicle cream in the treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented actinic keratosis of the face and scalp when using daylight photodynamic therapy (DL-PDT).
Conditions: Actinic Keratoses
Intervention / Treatment:
DRUG: MAL 16.8% cream, DRUG: MAL Vehicle Cream
Location: United States, Puerto Rico
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE
|
Inclusion Criteria:
* Participants aged >= 18 years at the Screening visit.
* Participants had at least 4, but no more than 12, clinically-confirmed thin or moderately thick, non-hyperkeratotic, non-pigmented AKs located on the face (e.g., forehead, cheek, chin), and balding scalp.
* Female Participants of non-childbearing potential.
* Participants fully understood and signed an ICF before any investigational procedure(s) are performed.
Exclusion Criteria:
* Participants with pigmented AK in the treatment areas.
* Female participants who were pregnant, nursing, or planning a pregnancy during the study.
* Participants with a clinical diagnosis of a skin disease other than AK.
* Immunocompromised participants.
* Participants with any condition that may be associated with a risk of poor protocol compliance.
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NCT_ID
NCT04085367
|
Study_NameMulticenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face
| 11,312 |
Study Objectives
The goal of this clinical research study is to find the highest tolerable doses of the combinations of lenalidomide and other drugs that can be given to patients with advanced cancer. The safety of the drug combinations will also be studied.
Conditions: Advanced Cancers
Intervention / Treatment:
DRUG: Lenalidomide, DRUG: Bevacizumab, DRUG: Sorafenib, DRUG: Temsirolimus, DRUG: Lenalidomide, DRUG: Oxaliplatin, DRUG: Leucovorin, DRUG: 5-fluorouracil
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients with advanced or metastatic cancer that is refractory to standard therapy, has relapsed after standard therapy, or for which there is no standard therapy available.
* Patients must be >= 3 weeks beyond treatment with a cytotoxic chemotherapy regimen, therapeutic radiation, or major surgery. After targeted or biologic therapy there should be 5 half-lives or three weeks, whichever is shorter. Patients may have received palliative localized radiation immediately before or during treatment, providing radiation is not delivered only to the site of disease being treated under this protocol.
* Eastern Cooperative Oncology Group (ECOG) performance status <= 2
* Patients must have normal organ and marrow function, defined as absolute neutrophil count >= 1,000/mL; platelets >=50,000/mL (unless these abnormalities are due to bone marrow involvement); creatinine clearance >= 50 ml/min by Cockcroft-Gault formula; total bilirubin <= 2.0; and alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase(SGPT) <= 5 X upper limit of normal (ULN) (unless patient has liver metastases).
* All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International unit (mIU)/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
* Patients must be able to understand and be willing to sign a written informed consent document.
* Must be >= 18 years.
Exclusion Criteria:
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
* Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
* Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
* Use of any other experimental drug or therapy within 21 days of baseline.
* Known hypersensitivity to thalidomide.
* History of hypersensitivity to any component of the formulation.
* The development of erythema nodosum, if characterized by a desquamating rash while taking thalidomide or similar drugs.
* Patients unwilling or unable to sign informed consent document.
* Uncontrolled systemic vascular hypertension (Systolic blood pressure >140 mmHg, diastolic blood pressure > 90 mmHg on medication) for patients treated in the bevacizumab or sorafenib arms.
* Patients with active deep venous thrombosis or pulmonary embolism or patients receiving anti-coagulation.
* Patients with clinically significant cardiovascular disease: History of cerebro-vascular accident (CVA) within 6 months; Myocardial infarction or unstable angina within 6 months; Unstable angina pectoris.
* Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1.
* Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0 of protocol treatment.
* Patients that are taking CYP3A4 inducers and/or inhibitors, being considered for the temsirolimus arm: If a patient has a history of taking CYP3A4 inducers and/or inhibitors prior to enrollment on the temsirolimus arm, it is strongly recommended that the patient stops the drug and waits at least 5 half-lives of said drug before initiating therapy on the temsirolimus arm.
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NCT_ID
NCT01183663
|
Study_NameLenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX)
| 4,642 |
Study Objectives
This open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab \[RO5072759 (GA101)\] in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients will receive 8 cycles of obinutuzumab (1000 mg intravenously on Day 1 of each 21-day cycle, during Cycle 1 obinutuzumab will also be infused on Days 8 and 15) in combination with CHOP chemotherapy on Day 1 of cycles 1 to 6. A substudy will investigate the drug-drug interaction of obinutuzumab with CHOP chemotherapy agents. For the substudy, an additional cohort of approximately 15 patients are planned to be enrolled at a subset of investigational sites.
Conditions: Lymphoma, B-Cell
Intervention / Treatment:
DRUG: obinutuzumab, DRUG: cyclophosphamide, DRUG: doxorubicin, DRUG: prednisone, DRUG: vincristine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
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Inclusion Criteria:
* Adult patients, >=18 years
* Previously untreated cluster of differentiation antigen 20 (CD20)-positive diffuse large B-cell lymphoma
* Ann Arbour Stage III/IV and bulky II (mass >10 cm)
* At least one bi-dimensionally measurable lesion defined as >1.5 cm in its largest dimension by CT scan
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Left ventricular ejection fraction >=50%
* Adequate hematologic function
Exclusion Criteria:
* Transformed lymphoma (follicular IIIB) if previously treated with chemotherapy or immunotherapy
* Prior therapy for diffuse large B-cell lymphoma except for nodal biopsy or local irradiation
* Central nervous system (CNS) lymphoma, primary mediastinal large cell lymphoma, primary cutaneous lymphoma, primary effusion lymphoma
* Patients who received cytotoxic drugs or rituximab as part of their treatment for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody
* Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1
* Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
* History of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix, or malignancy treated with or without curative intent and in remission without treatment for >=2 years prior to enrolment
* Positive for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or human T-cell leukemia virus (HTLV-1) infection
* Pregnant or lactating women
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NCT_ID
NCT01414855
|
Study_NameA Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)
| 12,946 |
Study Objectives
This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: bevacizumab [Avastin], DRUG: Chemotherapy
Location: Israel, Germany, Spain, Brazil, Italy, Austria, Greece, Croatia, Slovakia, France, Switzerland, Hungary, Argentina
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
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Inclusion Criteria:
* Female patients, >= 18 years
* Histologically confirmed HER2-negative breast cancer
* Disease progression during or following first-line treatment with Avastin and chemotherapy for locally recurrent or metastatic breast cancer
* Avastin treatment in first-line setting must have been a minimum of 4 cycles (15 mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy
* ECOG performance status 0 <= age <= 2
* At least 28 days since prior radiation therapy or surgery and recovery from treatment
Exclusion Criteria:
* Anti-angiogenic therapy or anti-vascular endothelial growth factors other than Avastin for first-line treatment
* Active malignancy other than superficial basal cell and superficial squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5 years
* Inadequate renal function
* Clinically relevant cardio-vascular disease
* Known CNS disease except for treated brain metastases
* Chronic daily treatment with high-dose aspirin (>325 mg/day) or clopidogrel (>75 mg/day)
* Pregnant or lactating women
|
NCT_ID
NCT01250379
|
Study_NameA Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Breast Cancer Progressing After First-Line Therapy With Avastin and Chemotherapy (TANIA)
| 9,007 |
Study Objectives
The objective of this study is to evaluate the safety and feasibility of oral rehydration therapy for short hydration in patients with biliary tract cancer who will undergo the chemotherapy including gemcitabine and cisplatin.
Conditions: Biliary Tract Cancer
Intervention / Treatment:
DRUG: Gemcitabine , Cisplatin, Oral Rehydration Solution (ORS), DRUG: Gemcitabine , Cisplatin
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria: 1. Patients with histological or cytological diagnosis of biliary tract cancer who haven't received cisplatin previously 2. Patients who is planned to receive chemotherapy including gemcitabine and cisplatin for biliary cancer for more than 12 weeks 3. >= 20 years years old 4. Eastern Cooperative Oncology Group Performance status of 0 or 1 5. Adequate main organ function 6. Fully oral intake ability to drink 500ml of solution before chemotherapy 7. Estimated life expectancy no less than 3 months 8. Written informed consent
* Exclusion Criteria: 1. Patients who received cisplatin previously 2. Radiological and clinical evidence of pulmonary fibrosis or interstitial pneumonia 3. Patients with uncontrolled diabetes mellitus or severe liver dysfunction or unstable angina or myocardial infarction within 3 months 4. Patients with serious infection 5. Pregnant or lactating female or patients who wish pregnant 6. Patients having severe allergy 7. Patients with other serious comorbid diseases 8. Patients with severe psychological disease 9. Patients with uncontrollable watery diarrhea 10. Patients with moderate or severe ascites /pleural effusion 11. Patients with severe psychological disease 12. Patients who are positive for a test of hepatitis B virus surface antigen (HBs antigen) without controlled with entecavir 13. Patients who is judged as an inappropriate case by the investigator
*
|
NCT_ID
NCT01917617
|
Study_NameOral Rehydration Therapy for Short Hydration in Chemotherapy With CDDP Plus GEM for Biliary Tract Cancer
| 7,996 |
Study Objectives
A phase 1/2 multi-center investigation of nab-sirolimus (also known as ABI-009, nab-rapamycin) in combination with mFOLFOX6 and Bevacizumab as first-line therapy in patients with metastatic colorectal cancer
Conditions: Colorectal Cancer Metastatic
Intervention / Treatment:
DRUG: nab-sirolimus
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients with histologically confirmed advanced or metastatic colorectal cancers for whom chemotherapy is indicated.
* Patients must not have had prior chemotherapy for advanced or metastatic disease. Patients could have received adjuvant chemotherapy or adjuvant chemo-radiotherapy.
* Patients must have at least 1 measurable site of disease according to RECIST v1.1 that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be radiological evidence of progression since the radiation.
* Eligible patients, >= 18 years, with Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
* Patients must not have been previously treated with an mTOR inhibitor.
* Adequate liver function:
1. Total bilirubin <=1.5 x upper limit of normal (ULN) mg/dL
2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 x ULN (<5 x ULN if the patient has liver metastases).
* Adequate renal function:
a. Serum creatinine <=2 x ULN or creatinine clearance >50 cc/hr (Cockroft-Gault).
* Adequate biological parameters:
1. Absolute neutrophil count (ANC) >=1.5 × 109/L
2. Platelet count >=100,000/mm3 (100 × 109/L)
3. Hemoglobin >=9 g/dL.
* Fasting serum triglyceride <=300 mg/dL; fasting serum cholesterol <=350 mg/dL.
* INR and PTT <1.5 x ULN (anticoagulation is allowed if target INR <1.5 on a stable dose of warfarin or on a stable dose of LMW heparin for >2 weeks at time of enrollment).
* Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy, and >=6 months since adjuvant FOLFOX therapy (adequately recovered from the acute toxicities of any prior therapy, including neuropathy should be grade <=1).
* Male or non-pregnant and non-breast feeding female:
* Females of child-bearing potential must agree to use effective contraception without interruption from 28 days prior to starting IP throughout 3 months after last dose of IP and have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study treatment. A second form of birth control is required even if she has had a tubal ligation.
* Male patients must practice abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study and throughout 3 months after last dose of IP. A second form of birth control is required even if he has undergone a successful vasectomy.
* Life expectancy of >3 months, as determined by the investigator.
* Ability to understand and sign informed consent.
* Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures.
Exclusion Criteria:
* History of severe and uncontrolled allergic reactions to bevacizumab
* Prior treatment with FOLFOX or bevacizumab within the preceding 4 weeks
* Patients currently receiving or have received anticancer therapies within 4 weeks of the start of study treatment (including chemotherapy, radiation therapy, antibody based therapy, etc.)
* Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
* Chronic treatment with systemic steroids or another immunosuppressive agent; topical or inhaled corticosteroids are allowed
* Recent infection requiring systemic anti-infective treatment that was completed <=14 days prior to enrollment (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection).
* Patients who have any severe and/or uncontrolled medical or psychiatric conditions or other conditions that could affect their participation including:
1. Known active uncontrolled or symptomatic central nervous system (CNS) metastases. A patient with controlled and asymptomatic CNS metastases may participate in this study. As such, the patient must have completed any prior treatment for CNS metastases >=28 days (including radiotherapy and/or surgery) prior to start of treatment in this study and should not be receiving chronic corticosteroid therapy for the CNS metastases.
2. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction <=6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
3. Pre-existing severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air (Note: spirometry and PFTs not required to be performed unless clinically indicated).
4. Uncontrolled diabetes as defined by fasting serum glucose >1.5x ULN or by HbA1c >8% despite adequate therapy.
5. Any active (acute or chronic) or uncontrolled infection/ disorders.
6. Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy. Note, controlled non-melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer, or other adequately treated carcinoma-in-situ may be eligible, after documented discussion with the sponsor / medical monitor.
7. Known liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).
* Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
* A known history of HIV seropositivity.
* Active Hepatitis B or Hepatitis C. Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.
* Patients with an active bleeding diathesis or on oral anti-vitamin K medication (except low dose Coumadin).
* Use of strong inhibitors and inducers of CYP3A4 within the 14 days prior to receiving the first dose of ABI-009. Additionally, use of any known CYP3A4 substrates with narrow therapeutic window (such as fentanyl, alfentanil, astemizole, cisapride, dihydroergotamine, pimozide, quinidine, terfanide) within the 14 days prior to receiving the first dose of ABI-009.
|
NCT_ID
NCT03439462
|
Study_NameNab-Sirolimus in Combination With FOLFOX & BEV as 1st Line Therapy in Patients With Advanced or Metastatic Colorectal Cancer
| 5,600 |
Study Objectives
The Primary Objective is to evaluate the safety and tolerability of the DTRMWXHS-12 capsule in patients with relapsed/refractory MCL and recommend the dose and dosing method (RP2D) used in phase II study.
The Secondary Objective is to evaluate the pharmacokinetics (PK) of multiple dose oral administration of DTRMWXHS-12 capsule in patients with relapsed/refractory MCL.
The Exploratory Objective is to preliminarily evaluate the efficacy of DTRMWXHS-12 capsule in patients with relapsed/refractory MCL.
Conditions: Mantle Cell Lymphoma
Intervention / Treatment:
DRUG: DTRMWXHS-12
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria
* 18 <= age <= 75 Years old (include 18 and 75), gender is not limited.
* Measurable lesions by computed tomography (CT)/magnetic resonance imaging (MRI). A measurable lesion is defined as follows: at least the longest diameter of one lymph node >1.5cm and clearly measurable in two vertical directions, or at least the longest diameter of one extranodal lesion >1cm (e.g., liver nodule); If only spleen or gastrointestinal mucosa is involved, corresponding examinations and evaluations will be conducted in the investigator's opinion.
* The diagnosis report must contain morphology and evidence of positive cyclin D1 by immunohistochemistry or evidence of t (11; 14). The above results are tested by immunohistochemistry, cytogenetics or Fluorescent in situ hybridization (FISH). After enrollment, tumor tissue (FFPE) blocks or sections must be sent to the central laboratory for confirmation of MCL.
* The laboratory parameters are as follows:
1. Hematology: Neutrophils >= 1.0×10^9/L without growth factor or blood transfusion, platelets >= 75×10^9L (>=50×10^9/L if bone marrow is involved), and hemoglobins > 9g/dL within 7 days before enrollment into the study.
2. Liver: Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) <= 2.5×ULN; total bilirubin <= 2×ULN (< 3×ULN when diagnosed as Gilbert's syndrome).
3. Kidney: Creatinine clearance>=30 ml/min (Evaluated by estimated glomerular filtration rate [eGFR] according to the Cockcroft-Gault Equation or the calculation equation of each site); Cockcroft-Gault equation= Female: (140-age)×weight(kg)×0.85/(72×serum creatinine (mg/dL)) Male: (140-age)×body weight(kg)/(72×serum creatinine(mg/dL))
4. international normalized ratio(INR) <= 1.5×ULN and activated partial thromboplastin time (APTT) <= 1.5×ULN, and for patients with acquired hemophilia or those treated with clotting factor inhibitors or vitamin K antagonists, the enrollment will be determined after discussion with the investigator.
* ECOG performance status score 0 <= age <= 2.
* Life expectancy > 3 months.
* There must be documentations on relapsed or refractory lymphoma or disease progression after systemic therapy and at least one but less than five therapies for mantle cell lymphoma were administrated previously (1 <= number of previous therapies < 5).
* No response with the last therapy (SD or PD during the treatment), or PD after the therapy.
* Patients with disease recurrence at least 3 months after autologous hematopoietic stem cell transplantation can be enrolled into the study, if there isn't any relevant active infection.
* Females of child-bearing potential must agree to use highly effective contraception methods during the study and at least 180 days after the last dose of the investigational drug. Highly effective contraception methods include abstinence, hysterectomy, bilateral ovariectomy without menstruation for six consecutive months, intrauterine contraception systems, hormonal contraception such as injectable contraceptives and oral contraceptives. Males must be sterilized via either vasectomy, or use barrier methods, while their female partners should take the effective contraception methods mentioned above.
* Patients are voluntary to sign the informed consent form and can understand and comply with all study requirements.
Exclusion Criteria
* Patients suffering from or previously suffering from CNS lymphoma.
* Patients received other BTK inhibitors prior to enrollment. Patients who received steroid anti-tumor therapy (a dose equivalent to>20mg/day of prednisone) within 7 days, or received chemotherapy, targeted therapy, or radiotherapy within 4 weeks, or received anti-tumor Chinese medicinal herbs or antibody therapy within 4 weeks, prior to first administration of DTRMWXHS-12 capsule.
* Patients received major surgery in the past 4 weeks before screening (determined by the investigator according to the patient's condition).
* Patients with active bleeding or combination with anticoagulant therapy within 3 <= age <= 6 months.
* Patients had undergone chemotherapy before and in whom the toxicity has not resolved (the toxicity has not resolved to <= grade 1 as per National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, except for hair loss, absolute neutrophil count (ANC) and platelets). For neutrophils and platelets, please refer to the criterion 4 [Neutrophils] and [Platelets] in the inclusion criteria.
* Patients with a history of other active malignant diseases within 2 years prior to enrollment into the study, excluding the following: (1) adequately treated cervical carcinoma in situ; (2) local skin basal cell carcinoma or squamous cell carcinoma; (3) malignant diseases that has been controlled and completely locally treated (by surgery or other means)
* Patients suffering from active cardiovascular diseases with clinical significance, such as uncontrolled arrhythmia, congestive heart failure, Grade 3 or 4 heart disease according to New York Heart Association (NYHA) Functional Classification, or those with history of myocardial infarction within 6 months before screening.
* QTcF>450 msecs or other significant ECG abnormalities, including second-degree atrioventricular block type Ⅱ, third-degree atrioventricular block.
* Patients who can't swallow capsules or with diseases significantly affect the gastrointestinal function, such as malabsorption syndrome, gastric or intestinal resection, symptomatic inflammatory bowel disease, or partial or complete intestinal obstruction.
* Uncontrolled systemic infections or infections requiring to be treated with intravenous antibacterial agents.
* Patients who previously received allogeneic stem cell transplantation.
* Patients known to have been infected with human immunodeficiency virus (HIV) or active hepatitis B or hepatitis C virus (polymerase chain reaction [PCR] or reverse transcription- polymerase chain reaction (RT-PCR) shows positive results).
* Hepatitis B test includes HBsAg, HBcAb and HBsAb. If the patient is HBsAg-negative but HBcAb-positive (regardless of HBsAb), the PCR technology will be used to detect hepatitis B virus (HBV) DNA, and the acceptable upper limit of normal in the table below is 1000 IU/mL. Considering different PCR kits may be used by different sites, the acceptable upper limit of normal for HBV DNA should be the normal value in the site. Hepatitis C test includes hepatitis C virus (HCV) antibody test, and if the HCV antibody is positive, the RT-PCR technology will be used to detect HCV RNA.
* Pregnant or lactating women.
* Any life-threatening disease, medical condition, or organ system dysfunction that, in the investigator's opinion, may affect subject safety or lead to study risks.
* Patients with poor compliance.
* Patients who receive treatment with a potent CYP3A (cytochrome P450, family 3, subfamily A) inhibitor or a potent CYP3A inducer within 7 days prior to enrollment.
|
NCT_ID
NCT03836768
|
Study_NameBTK Inhibitor DTRMWXHS-12 in Mantle Cell Lymphoma
| 9,151 |
Study Objectives
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is being studied. It also means that the FDA has not yet approved the drug for your type of cancer or for any use outside of research studies.
It has been found that some people with NSCLC have a change (mutation) in a certain gene called the EGFR gene. This mutated gene helps cancer cells grow. The majority of NSCLC patients with EGFR mutations achieve good outcomes with erlotinib or other EGFR inhibitor therapies, with a high response rate, prolonged progression-free survival and possibly improved overall survival from therapy. However, the 4% of EGFR mutant patients that harbor an exon 20 insertion mutation historically have reaped little benefit from EGFR-directed therapy due to the low affinity of this mutation for direct EGFR inhibitors, especially erlotinib and gefitinib (see Yasuda et al, Lancet Oncol 2011). This group of patients is ideal for studying other targeted therapeutic strategies that could affect the oncogene mutation in EGFR via alternative mechanisms.
AUY922 is an investigational drug that may stop cancer cells from growing abnormally. This drug has been used in other research studies. Information from those other research studies suggests that AUY922 may be effective in killing cancer cells in patients with exon 20 insertion mutations in EGFR.
The purpose of this study is to test the safety of AUY922 and determine how well AUY922 works for participants with advanced NSCLC and exon 20 insertion mutations in EGFR.
Conditions: Non Small Cell Lung Cancer
Intervention / Treatment:
DRUG: AUY922
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histologically or cytologically confirmed stage IV or recurrent NSCLC
* Measurable disease by RECIST 1.0
* Must have received at least one prior line of therapy for advanced lung cancer (no maximum number)
* Life expectancy of at least 12 weeks
Exclusion Criteria:
* Pregnant or breastfeeding
* Radiation within 2 weeks
* Cytotoxic chemotherapy or monoclonal antibodies within 4 weeks
* EGFR tyrosine kinase inhibitor within 2 weeks
* Other small molecule inhibitor within 2 weeks
* Experimental treatment within 30 days
* Prior treatment with any HSP90 or HDAC inhibitor compound
* Known and untreated brain metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to AUY922
* Unresolved diarrhea greater than or equal to CTCAE version 4, grade 1
* Major surgery within 2 weeks of starting study drug or have not recovered from side effects of surgery
* Known disorders due to a deficiency in bilirubin glucuronidation
* Requiring use of therapeutic doses of warfarin (Coumadin)
* History of long QT syndrome
* History of clinically manifest ischemic heart disease, heart failure or left ventricular dysfunction
* Clinically significant ECG abnormalities
* Other clinically significant heart disease
* Currently receiving treatment with any medication which has a relative risk of prolonging the QTc interval or inducing Torsades de Pointes
* On a cardiac pacemaker
* Concurrent malignancies or invasive cancers diagnosed within 3 years except for adequately treated basal cell cancer of the skin or in situ cancer of the cervix
* Known to be HIV positive
|
NCT_ID
NCT01854034
|
Study_NamePhase 2 Study of AUY922 in NSCLC Patients With Exon 20 Insertion Mutations in EGFR
| 7,022 |
Study Objectives
To estimate and compare the response rates in patients treated with mDCF based on methylation status of CHFR.
Conditions: Metastatic Esophageal Cancer, Gastroesophageal Cancer, Gastric Cancer
Intervention / Treatment:
DRUG: Docetaxel, DRUG: Leucovorin, DRUG: Fluorouracil, DRUG: Cisplatin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Patients must have metastatic disease of the esophagus, gastroesophageal junction or stomach. Patients with locally recurrent disease who are not deemed eligible for radiation are also permitted.
* Histological, cytologic or radiographic documentation of metastatic adenocarcinoma or squamous cell carcinoma of the esophagus, gastroesophageal junction or stomach. Radiologic, endoscopic, histologic or cytologic evidence of locally recurrent disease is also permitted.
* Patients must be untreated with chemotherapy for metastatic or locally recurrent disease. Prior radiation therapy is permitted.
* Patients must have measurable disease as per RECIST 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
* Age >18 years and <= 80 years.
* ECOG performance status <2 (Karnofsky >60%, see Appendix A).
* Life expectancy of greater than 3 months.
* Patients must have normal organ and marrow function.
* Patients must not have any of the following conditions:
* Recent major surgery, hormonal therapy (other than replacement) or chemotherapy, within 4 weeks prior to entering the study or those who have not recovered from the adverse events of treatment.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy on this trial.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
* Patients who are receiving any investigational agents.
* Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy used in the study.
* Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort; these drugs induce CYP3A and may decrease levels of taxanes. 5-FU is a strong CYP2C9 inducer, and concomitant use with carvedilol, celecoxib, fosphenytoin, fluoxetine, phenytoin, warfarin and other CYP2C9 substrates should be used with caution.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study because chemotherapy has the potential for teratogenic or abortifacient effects.
* HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with chemotherapeutic agents. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
|
NCT_ID
NCT01715233
|
Study_NamePhase II Study Using CHFR Methylation Status in Patients With Metastatic Esophageal, Gastroesophageal, Gastric Cancer.
| 21,277 |
Study Objectives
The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) in patients with hepatocellular carcinoma (HCC) .
Conditions: Hepatocellular Carcinoma
Intervention / Treatment:
OTHER: TACE+ICIs, PROCEDURE: TACE
Location: China
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* diagnosed with HCC by radiology, histology, or cytology;
* patients who underwent TACE combined with ICIs therapies ( with or without molecular targeted therapies) were included in the study group. For patients in the study group, ICIs therapies were received before the TACE or within 2 months after TACE and at least one cycle of immunotherapy has been received;
* during the same period, patients who underwent TACE without the combination of ICIs therapies ( with or without molecular targeted therapies) were included into the control group;
* patients who underwent TACE combined with ICIs therapies and molecular targeted therapies, molecular targeted therapies must be performed simultaneously with TACE or immunotherapy.
Exclusion Criteria:
* exceeding the time interval of the combination therapy defined above;
* missing follow-up data;
|
NCT_ID
NCT04975932
|
Study_NameEfficacy and Safety of TACE in Combination With ICIs for HCC: a Real-world Study
| 15,636 |
Study Objectives
The main objective of the trial is to document the efficacy of NGR-hTNF administered as maintenance treatment at 0.8 µg/m2 weekly in advanced malignant pleural mesothelioma
Conditions: Advanced Malignant Pleural Mesothelioma
Intervention / Treatment:
DRUG: NGR-hTNF, DRUG: Placebo, OTHER: Best Supportive Care
Location: Italy, Germany, Russian Federation
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE
|
Inclusion Criteria:
* Age >= 18 years
* Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatoid, mixed, or unknown
* Patients with non-progressive disease after six cycles of first-line, pemetrexed-based regimen administered for advanced or metastatic disease
* ECOG Performance Status 0 - 1
* Life expectancy of >= 12 weeks
* Adequate baseline bone marrow, hepatic and renal function, defined as follows:
1. Neutrophils >= 1.5 x 109/L; platelets >= 100 x109/L; hemoglobin >= 9 g/dL
2. Bilirubin <= 1.5 x ULN
3. AST and/or ALT <= 2.5 x ULN in absence of liver metastasis or <= 5 x ULN in presence of liver metastasis
4. Serum creatinine < 1.5 x ULN
* Measurable or non-measurable disease according to malignant pleural mesothelioma-modified RECIST criteria
* Patients may have had prior therapy providing the following conditions are met:
* Surgery: wash-out period of 14 days
* Radiation therapy: wash-out period of 28 days
* Chemotherapy: wash-out period of 21 days
* Patients must give written informed consent to participate in the study
Exclusion Criteria:
* Patients must not receive any other investigational agents while on study
* Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
* Uncontrolled hypertension
* QTc interval (congenital or acquired) > 450 ms
* History or evidence upon physical examination of Central Nervous System disease unless adequately treated
* Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
* Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
* Pregnancy or lactation.
|
NCT_ID
NCT01358084
|
Study_NamePhase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced MPM
| 16,609 |
Study Objectives
To determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.
Conditions: Carcinoma, Non-Small-Cell Lung, Lung Cancer
Intervention / Treatment:
DRUG: Nexavar (Sorafenib, BAY43-9006), DRUG: Nexavar (Sorafenib, BAY43-9006), DRUG: Bevacizumab, DRUG: Bevacizumab, DRUG: Bevacizumab, DRUG: Bevacizumab, DRUG: Paclitaxel, DRUG: Carboplatin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: BASIC_SCIENCE
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Patients must have Stage IIIB (with malignant pleural effusions) or Stage IV histological or cytological confirmation of non-small cell carcinoma (excluding squamous)
* Age >= 18 years
* Patients must have at least 1 evaluable lesion. Lesions must be evaluated by CT scan or MRI
* ECOG Performance Status of 0 to 1
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:
* Hemoglobin >= 9.0 g/dL
* White blood cell (WBC) count >= 2,500/mm3
* Absolute neutrophil count (ANC) >= 1,500/mm3
* Platelet count >= 100,000/mm3
* Total bilirubin <= 1.5 times the upper limit of normal (ULN)
* ALT and AST <= 2.5 X ULN (<= 5 X ULN for patients with liver involvement)
* INR <= 1.5 and aPTT within normal limits
* Serum creatinine <= ULN or creatinine clearance (CrCl) >= 45 mL/min (CrCl = Wt (kg) x (140-age)/72 x Cr level, female x 0.85) for patients with creatinine levels above institutional normal
* Urinalysis (UA) must show less than 1+ protein in urine, or the patient will require a repeat UA. If repeat UA shows 1+ protein or more, a 24 hour urine collection will be required and must show total protein <= 1000 mg/24 hour to be eligible
Exclusion Criteria:
* Patients with squamous histology
* Cardiac disease: Congestive heart failure > Class II NYHA; active coronary artery disease (MI more than 6 months prior to study entry is allowed); or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
* Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management
* HIV infection or chronic hepatitis B or C
* Active clinically serious infections (> Grade 2 NCI-CTC Version 3.0)
* Evidence or history of CNS disease, including primary brain tumors, seizures disorders, or any brain metastasis
|
NCT_ID
NCT01069328
|
Study_NameDose Escalating Study With BAY43-9006 With Carboplatin, Paclitaxel and Bevacizumab in Untreated Stage IIIb Non-small Cell Lung Cancer (NSCLC)
| 19,738 |
Study Objectives
To assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations, to determine if cell growth can be slowed.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: celecoxib, OTHER: placebo
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* women who have a high risk of breast cancer
* older than 18 years
Exclusion Criteria:
* anticoagulants
* marked breast tenderness
* pregnant or within twelve months of breast feeding/childbirth
|
NCT_ID
NCT00291694
|
Study_NameProtocol for Women at Increased Risk of Developing Breast Cancer
| 5,895 |
Study Objectives
The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.
Conditions: Relapsed or Plateau-Phase Multiple Myeloma
Intervention / Treatment:
DRUG: DENOSUMAB
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* age >= 18 years
* clinical diagnosis of relapsed or plateau-phase multiple myeloma
* measurable disease (>0.5 g/dL) as determined by special blood tests
* ECOG 0 or 1
Exclusion Criteria:
* newly diagnosed myeloma
* non-secretory myeloma
* plasma cell leukemia or plasma cell dyscrasia with POEMS syndrome
* prior allogeneic stem cell transplant
* administration of oral or IV bisphosphonates within 2 weeks of enrollment to study
Other criteria also apply.
|
NCT_ID
NCT00259740
|
Study_NameOpen-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
| 10,677 |
Study Objectives
Data suggests that combining ramucirumab with immunotherapy in non-small cell lung cancer (NSCLC) patients who have previously received immune checkpoint blockers (ICBs) may be more effective than traditional therapy. The investigators propose a pilot study to test the combination of ramucirumab and atezolizumab in patients with advanced-stage NSCLC patients previously treated with ICB.
Conditions: Non-small Cell Lung Cancer, Non Small Cell Lung Cancer, NSCLC
Intervention / Treatment:
DRUG: Ramucirumab, DRUG: Atezolizumab, PROCEDURE: Peripheral blood draw, PROCEDURE: Biopsy
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histologically or cytologically confirmed squamous or non-squamous non-small cell lung cancer. Patients with known EGFR or ALK mutations are eligible only if they have received at least one line of targeted therapy for these mutations.
* Availability of archival biopsy tissue or willingness to undergo a "baseline" biopsy prior to initiation of the trial for biomarker analysis, including PD-L1 by IHC. Note: Results of PD-L1 testing are not required for enrollment.
* Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 10 mm with CT scan, as >= 20 mm by chest x-ray, or >= 10 mm with calipers by clinical exam.
* Prior use of an immune checkpoint blocker alone or in combination therapy.
* At least 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status <= 1
* Normal bone marrow and organ function as defined below:
* Absolute neutrophil count >= 1,500/cumm
* Platelets >= 100,000/cumm
* Hemoglobin >= 9.0 g/dL
* Total bilirubin <= 1.5 x ULN
* AST(SGOT)/ALT(SGPT) <= 3.0 x ULN or 5.0 x ULN in the setting of liver metastasis
* Serum creatinine <= 1.5 x ULN or CrCl >= 40 mL/min. if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed
* Adequate coagulation function as defined by:
* INR <= 1.5
* PTT/aPTT < 1.5 x ULN
* Note: Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin (LMWH). If receiving warfarin, the patient must have an INR <=3.0. For heparin and LMWH there should be no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices).
* Urinary protein <= 1+ on dipstick or routine urinalysis; if urine dipstick or routine analysis is >= 2+, a 24-hour urine collection for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
* Treatment with cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to Cycle 1, Day 1.
*Note: Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea or premedication for contrast dye allergy) are eligible. The use of inhaled corticosteroids for chronic obstructive pulmonary disease (COPD) and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
* A history of other malignancy <= 3 years previous with the exception of patients with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per SOC management (e.g., Rai Stage 0 chronic lymphocytic leukemia, prostate cancer with Gleason score <= 6 and prostate-specific antigen (PSA <= 10 ng/mL, etc.).
* Currently receiving any other investigational agents.
* Symptomatic or untreated asymptomatic brain metastases. Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, and stereotactic radiosurgery) ending at least 2 weeks prior to randomization, or after surgical resection performed at least 28 days prior to randomization. The patient may have no evidence of Grade >=1 CNS hemorrhage based on pretreatment MRI or IV contrast CT scan (performed within 21 days before randomization).
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to atezolizumab, ramucirumab, any other immune checkpoint blockade, chimeric or humanized antibodies, fusion proteins, or other agents used in the study.
* Receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted.
* Arterial or venous thromboembolic event, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to enrollment.
* Uncontrolled or poorly controlled hypertension (> 160 mmHg systolic or > 100 mmHg diastolic for > 4 weeks) despite standard medical management.
* Gastrointestinal perforation, and/or fistula, or risk factors for perforation within 6 months prior to enrollment.
* Grade 3 or 4 gastrointestinal bleeding within 3 months prior to enrollment.
* History of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis.
*Note: Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible. Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible.
* History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest CT scan.
* Hemoptysis (defined as bright red blood or >= ½ teaspoon) within 2 months prior to Cycle 1 Day 1 or with radiographic evidence of intratumor cavitation or radiologically documented evidence of major blood vessel invasion or encasement by cancer.
* Serious or non-healing would, ulcer, or bone fracture within 28 days prior to Cycle 1 Day 1.
* Undergone major surgery within 28 days prior to Cycle 1 Day 1, or minor surgery/subcutaneous venous access device placement within 7 days prior to Cycle 1 Day 1, or has elective or planned major surgery to be performed during the course of the clinical trial.
* Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis at a level of Child-Pug B or worse, cirrhosis (any degree) with a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis (defined as ascites from cirrhosis requiring diuretics or paracentesis), fatty liver, and inherited liver disease.
--Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (defined as, HBV surface antigen (HBsAg) positive and HBV core antibody (HbcAb) positive with reflex positive HBV DNA. Note: Patients with past or resolved hepatitis B infection (defined as having a negative HBsAg test and a positive HBcAb test or treated HCV with negative HCV RNA are eligible.
* Known HIV-positivity.
* Active tuberculosis.
* Administration of a live, attenuated influenza vaccine within 4 weeks before Cycle 1 Day 1 or at any time during the study.
* Severe infections within 2 weeks prior to Cycle 1 Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. Received oral or intravenous (IV) antibiotics within 2 weeks prior to Cycle 1 Day 1. Note: Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible.
* History of deep venous thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 3 months prior to Cycle 1 Day 1.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days of study entry.
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NCT_ID
NCT03689855
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Study_NameRamucirumab and Atezolizumab After Progression on Any Immune Checkpoint Blocker in NSCLC
| 8,754 |
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