Search is not available for this dataset
data
stringlengths 198
8.94k
| criteria
stringlengths 19
16.5k
| NCT_ID
stringlengths 19
19
| Study_Name
stringlengths 29
311
| __index_level_0__
int64 0
22.6k
|
|---|---|---|---|---|
Study Objectives
Researchers are looking for a better way to treat people diagnosed with liver cancer which may have spread to nearby tissue and is unlikely to be cured or controlled with treatment (advanced metastatic hepatocellular carcinoma, HCC). Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.
In this trial, the researchers will learn more about the trial treatment, regorafenib, in a small number of participants. They will study the results when the trial treatment is taken with another cancer treatment called pembrolizumab.
There will be 2 parts to this trial. The part 1 (pilot phase) will include about 52 men and women. The part 2 (expansion phase) will include about 67 men and women. All of the participants will have HCC and will be aged 18 years or older. All of the participants will have tried other treatments that did not help their HCC. These other treatments (PD-1/PD-L1 Immune Checkpoint Inhibitors) are designed to work by stopping the activity of certain proteins in the immune system thought to play a role in HCC.
During both parts of the trial, the participants will take regorafenib and receive pembrolizumab. In the pilot phase, there will be 2 groups of participants. The group that each participant joins will be based on the treatment they already received for their HCC. The researchers will review the results in each group to learn if regorafenib and pembrolizumab are helping one group of participants more than others. Outcome of this review will determine the population to be treated in the expansion phase.
Conditions: Hepatocellular Carcinoma
Intervention / Treatment:
DRUG: Pembrolizumab, DRUG: Regorafenib (Stivarga, BAY73-4506)
Location: Israel, Germany, United States, Spain, Italy, Japan, France, Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SEQUENTIAL
Masking: NONE
|
Inclusion Criteria:
* >= 18 years on the day of signing informed consent.
* Histological or cytological confirmation of HCC or non-invasive diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants.
* Unresectable advanced HCC eligible for systemic therapy.
* Participants must have progressed after only one prior line of systemic immunotherapy treatment with an anti-PD-1/PD-L1 mAb administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. A wash out period of at least 28 days or 5 half-lives, whichever is shorter, must be completed for eligibility in this trial. PD-1/PD-L1 treatment progression is defined by meeting all of the following criteria:
1. Has received at least 2 doses of an approved anti PD-1/PD-L1 mAb or received PD-1/PD-L1 treatment for 8 weeks, whichever is longer.
2. Has demonstrated disease progression after PD-1/PD-L1 treatment as defined by RECIST 1.1. In the absence of rapid clinical progression, the initial evidence of RECIST 1.1 disease progression is to be confirmed using iRECIST by a second assessment no less than four weeks from the date of the first documented progressive disease.
i. This determination is made by the investigator. Once progressive disease is confirmed, the initial date of RECIST 1.1 progressive disease documentation will be considered that date of disease progression.
ii. In cases of unequivocal clinical or radiological progression, disease progression confirmation may not be required after documented discussion and approval by the sponsor.
c. Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1/PD-L1 mAb.
* Participants who receive anti-PD-1 therapy as adjuvant treatment following complete resection of liver cancer and have disease recurrence (unresectable locoregional disease or distant metastases) are eligible if they progressed while on active treatment or within 6 months of stopping anti-PD-1 therapy. This will be considered the first line of systemic therapy.
For these participants, the following applies:
* a second assessment to confirm disease progression beyond recurrence is not required; and
* they must have received at least 2 prior doses of anti-PD-1/PD-L1 mAb.
* Barcelona Clinic Liver Cancer (BCLC) stage B or C.
* Liver function status should be Child-Pugh (CP) Class A within 7 days prior to the first dose of study intervention. CP status should be calculated based on clinical findings and laboratory results during the screening period.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 within 7 days prior to the first dose of study intervention.
* At least one measurable lesion by CT scan or MRI according to RECIST 1.1. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if there has been demonstrated progression in the lesion.
* Participants with controlled (treated) hepatitis B virus (HBV) infection will be allowed if they meet the following criteria:
* Antiviral therapy for HBV must be given for at least 4 weeks and HBV viral load must be less than 500 IU/mL prior to first dose of study intervention.
* Participants on active HBV therapy with viral loads under 500 IU/ml should stay on the same therapy throughout study treatment.
* Participants who are anti-HBc (+), negative for HBsAg, negative for anti-HBs, and have an HBV viral load under 500 IU/mL that do not require HBV antiviral prophylaxis.
* Provision of recent tumor tissue (as defined below) is mandatory at screening. Exceptions will be accepted for participants with no recent baseline tumor tissues after documented discussion and approval by the sponsor.
* Tumor tissue obtained within 180 days of enrollment and after the last dose of most recent anti-cancer therapy.
* Or a new biopsy.
Exclusion Criteria:
* Fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes.
* Patients with disease that is suitable for local therapy administered with curative intent.
* Patients who experienced any Common Terminology Criteria for Adverse Events (CTCAE) >= 3 or any other immune- related toxicities that led to permanent discontinuation of treatment with immune checkpoint inhibitors in 1 L.
* Persistent proteinuria of CTCAE Grade 3 or higher.
* Diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study interventions.
* Active autoimmune disease.
* History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
* Any hemorrhage or bleeding event CTCAE Grade >= 3 within 28 days prior to the start of study medication.
* Patients with large esophageal varices at risk of bleeding that are not being treated with conventional medical intervention.
* Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication.
* Ongoing infection CTCAE Grade > 2 requiring systemic therapy.
* Dual active HBV infection (HBsAg (+) and / or detectable HBV DNA) and HCV infection (anti-HCV Ab (+) and detectable HCV RNA) at study entry.
* Uncontrolled hypertension (systolic blood pressure >= 140 mmHg or diastolic pressure >= 90 mmHg) on more than 2 separate measurements despite optimal medical management.
* Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months).
* Myocardial infarction less than 6 months before start of study intervention.
* Pleural effusion or ascites that causes respiratory compromise (CTCAE Grade >= 2 dyspnea).
* Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 3 years prior to study entry.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable.
* Significant acute gastrointestinal disorders with diarrhea as a major symptom.
* Prior monotherapy treatment with any tyrosine kinase inhibitor in 1L.
* Prior treatment with regorafenib, in combination regimens with immune checkpoint inhibitors.
* Transfusion of blood products within 7 days prior to signing informed consent, or administration of colony stimulating factors within 4 weeks prior to signing informed consent.
* Previous assignment to treatment during this study.
* Previous (at least a minimum of 28 days, or 5 half-lives of an investigational drug before the start of study treatment, whichever is shorter) or concomitant participation in another clinical study with investigational medicinal product(s).
|
NCT_ID
NCT04696055
|
Study_NameRegorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors
| 6,265 |
Study Objectives
This randomized phase III trial studies how well methotrexate works compared to dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in chemotherapy, such as methotrexate and dactinomycin, 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. It is not yet known whether methotrexate is more effective than dactinomycin in treating gestational trophoblastic disease.
Conditions: Choriocarcinoma, FIGO Stage I Gestational Trophoblastic Tumor, FIGO Stage II Gestational Trophoblastic Tumor, FIGO Stage III Gestational Trophoblastic Tumor, Hydatidiform Mole
Intervention / Treatment:
BIOLOGICAL: Dactinomycin, DRUG: Leucovorin Calcium, DRUG: Methotrexate, OTHER: Quality-of-Life Assessment
Location: United States, United Kingdom, Japan, Canada, Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE
|
Inclusion Criteria:
* Patients who meet International Federation of Gynecology and Obstetrics (FIGO) stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN): post molar GTN or choriocarcinoma (as defined below); patients may have had a second curettage but must still meet GTN criteria below:
* Post molar GTN
* For the purposes of this study, patients must have undergone evacuation of a complete or partial hydatidiform mole and then meet the criteria for GTN defined as:
* A < 10% decrease in the hCG level using as a reference the first value in the series of 4 values taken over a period of 3 weeks (> 50 mIU/ml minimum) OR
* A > 20% sustained rise in the hCG taking as a reference the first value in the series of 3 values taken over a period of 2 weeks (> 50 mIU/ml minimum) OR
* A persistently elevated hCG level a period of 6 months or more following the initial curettage (> 50 mIU/ml minimum)
* Choriocarcinoma
* Histologically proven non-metastatic choriocarcinoma OR
* Histologically proven metastatic choriocarcinoma if the metastatic site(s) is restricted to one (or more) of the following: vagina, parametrium, or lung
* World Health Organization (WHO) risk score 0 <= age <= 6
* Patients must be willing to practice effective contraception for the duration of the study
* White blood cell count (WBC) >= 3,000 cells/mcL
* Granulocytes >= 1,500/mcL
* Platelets >= 100,000/mcL
* Creatinine =< 2.0 mg/dcL
* Bilirubin =< 1.5 x institutional normal
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x institutional normal
* Alkaline phosphatase =< 3 x institutional normal
* Patients who have met the pre-entry requirements
* Before enrolling a patient, the institution must verify the availability of an adequate supply of methotrexate for a full course of therapy
* Patients must have signed an approved informed consent and authorization permitting release of personal health information
Exclusion Criteria:
* Patients who do not have GTN
* Patients with non-gestational choriocarcinoma
* Patients who have previously been treated with cytotoxic chemotherapy; however, patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study
* Patients who have received prior pelvic radiation
* Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
* Patients with Gynecologic Oncology Group (GOG) performance status of 3 or 4
* Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
* Patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up
* Patients who wish to breast-feed during treatment
|
NCT_ID
NCT01535053
|
Study_NameDactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia
| 22,118 |
Study Objectives
The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus placebo in reducing the transfusion requirements in anemic patients with multiple myeloma, and to investigate the quality-of-life benefits associated with the use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
Conditions: Anemia, Multiple Myeloma
Intervention / Treatment:
DRUG: epoetin alfa
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE
|
Inclusion Criteria:
* Patients with documented multiple myeloma defined by standard criteria, with at least 6 months having elapsed since beginning chemotherapy
* having a self-care performance score of 0, 1, 2, or 3 (patients' ability to perform daily activities, a score ranging from 0 [fully active, no disease restriction] to 3 [capable of only limited self-care, confined to bed or chair more than 50% of waking hours])
* having a life expectancy of at least 3 months
* having a baseline hemoglobin <11 g/dL and baseline count of <100,000 microliter for developing red cells
* with an ability to administer self-injections
Exclusion Criteria:
* Patients having clinically significant disease other than cancer
* having evidence of uncontrolled hypertension or a history of seizure
* having untreated iron, folate, or Vitamin B12 deficiency
* receiving a transfusion within 7 days of study entry, or androgen therapy within 1 month of study entry
* receiving dialysis at baseline screening
|
NCT_ID
NCT00270101
|
Study_NameThe Effect of Epoetin Alfa on the Anemia of Patients With Multiple Myeloma
| 11,284 |
Study Objectives
Recently, European Medicines Agency approved ibrutinib and idelalisib to treat Chronic Lymphocytic Leukemia (CLL) and two lymphomas: Follicular Lymphoma (FL) for ibrutinib and Mantle cell lymphoma (MCL) for idelalisib.
Clinical trials for ibrutinib and idelalisib were performed with a small number of patients (300-350) and showed several side effects profiles. Since, pharmacokinetic properties of these 2 drugs highlight a interindividual variability of pharmacokinetic. The aim of this study is to determine the association between clinically significant side effects occurrence during the first year of treatment and plasma mean concentration of the steady state of ibrutinib or idelalisib at 1 month.
Conditions: Hematological Malignancies
Intervention / Treatment:
OTHER: Blood samples for pharmacokinetics exploration, OTHER: Imagery, OTHER: Quality of life scale, OTHER: Detection of adverse events, GENETIC: Saliva samples, GENETIC: Blood sample, OTHER: Biological statement, OTHER: Clinical examination
Location: France
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Evidence of Chronic Lymphocytic Leukaemia (CLL), or Follicular Lymphoma (FL) or Mantle cell lymphoma (MCL) and a first prescription of idelalisib or ibrutinib
* Patients must give written informed consent
* Patients with Health Insurance System
Exclusion Criteria:
* Patient who several blood tests can't be performed (poor venous access)
* Patients under legal guardian
* Pregnant or breastfeeding women
|
NCT_ID
NCT02824159
|
Study_NameAssociation Between Side Effects Occurrence and Concentrations of Ibrutinib and Idelalisib
| 11,964 |
Study Objectives
This is a retrospective, multicenter and observational study of Osimertinib monotherapy treatment in Subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) EGFR-T790M mutation-positive who have received the treatment within the Special Use Medication Program (SUMP) in Spain.
Conditions: Non Small Cell Lung Cancer
Intervention / Treatment:
DRUG: Osimertinib
Location: Spain
Study Design and Phases
Study Type: OBSERVATIONAL
|
Inclusion Criteria:
* Squamous or Non-Squamous, non-small cell lung cancer (NSCLC), Stage IIIb/IV (histologically or cytologically confirmed), EGFRm/T790M, who received osimertinib treatment within the Spanish special use medication program of Osimertinib (SUMP).
* Alive patients must have signed, dated and IRB/EC-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.
Exclusion Criteria:
* Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form.
* Patients who were accepted in the SUMP, but did not receive treatment.
|
NCT_ID
NCT03790397
|
Study_NameOsimertinib in Subjects With Advanced Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive
| 21,575 |
Study Objectives
This trial investigates pemetrexed and cisplatin followed by pemetrexed and cisplatin in combination with radiotherapy in participants with locally advanced, non-small cell lung cancer (NSCLC). The purpose of the study is to assess the antitumor activity as measured by progression free survival 1 year after start of treatment with study drug.
Conditions: Non Small Cell Lung Cancer
Intervention / Treatment:
DRUG: Pemetrexed, DRUG: Cisplatin, RADIATION: Thoracic Radiotherapy
Location: France, Germany, Spain, Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE
|
Inclusion Criteria:
* Histologic or cytologic diagnosis of unresectable nonsquamous Stage IIIA or Stage IIIB (without malignant pleural/pericardial effusions) NSCLC.
* Have an ECOG performance status of 0 or 1.
* Previous radiation therapy should have been limited and must not have included thoracic radiation, whole pelvis radiation, or radiation to >25% of the participant's bone marrow, participants must have recovered from the toxic effects of radiation treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study entry.
* Have at least 1 unidimensionally measurable lesion meeting RECIST guidelines, version 1.0.
* Estimated life expectancy of at least 12 weeks.
* Participant compliance and geographic proximity that allow adequate follow-up.
* Adequate bone marrow reserve, hepatic-, renal- and pulmonary function.
* Participants must sign an Informed Consent Document.
* Participants must have a total lung V20 less than or equal to 35%.
* For women: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen, during and for 6 months after the treatment period; must have a negative serum pregnancy test within 7 days before study enrollment and must not be breast-feeding. For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period.
* Have not received prior systemic anticancer therapy for NSCLC.
Exclusion Criteria:
* Have received treatment within the last 30 days of enrollment with a drug that has not received regulatory approval for any indication at the time of study entry.
* Have previously completed or withdrawn from this study or any other study investigating pemetrexed.
* Have a serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the participant's ability to adhere to the protocol.
* Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.
* Have had a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or non-melanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Participants with a history of low-grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously.
* Are receiving concurrent administration of any other antitumor therapy.
* Have had weight loss of more than 10% over the previous 3 months before study entry.
* Are unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose less than or equal to 1.3 grams per day, for at least 2 days before (5 days for long-acting agents), the day of, and for at least 2 days after administration of pemetrexed.
* Are unable or unwilling to take folic acid or vitamin B12 supplementation.
* Are unable or unwilling to take corticosteroids.
* Have received a recent yellow fever vaccination (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination.
* Have known hypersensitivity to pemetrexed, cisplatin, or any of the excipients in these medicinal products.
* Have evidence of clinical hearing loss.
* Have clinically significant third-space fluid collections, that cannot be controlled by drainage or other procedures prior to study entry.
|
NCT_ID
NCT01000480
|
Study_NameA Study of Pemetrexed and Cisplatin, in Non Small Cell Lung Cancer
| 5,390 |
Study Objectives
To evaluate safety and efficacy of AIV001 treatment on low-risk basal cell carcinoma.
Conditions: Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma
Intervention / Treatment:
DRUG: AIV001
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE
|
Inclusion Criteria:
* Male or female, aged 18 <= age <= 80, inclusive
* No clinically relevant abnormalities identified by a detailed medical history and vital signs
* Presence of a histologically confirmed low risk BCC lesion, with well-defined borders, and with a largest diameter measure before biopsy of 5 mm to 20 mm, located on arms or trunk
* Histological diagnosis of the target lesion must have been conducted 5 to 30 days prior to Day 1
* No other dermatological disease within 50 mm of the target lesion at Day 1
* No prior or concurrent treatment of the target lesion (including radiation therapy)
* Willing to undergo surgical excision approximately 63 days after first treatment.
Exclusion Criteria:
* History or presence of systemic cancer
* Prior radiation treatment at the lesion site or anywhere else on the body within the past 20 years
* Concurrent disease or treatment that suppresses the immune system (eg, previous organ transplant history, etc.)
* Clinically relevant cardiovascular, endocrine, hepatic, neurologic, renal, or other major systemic disease that could complicate execution of the protocol or interpretation of the study results.
* History of thrombotic events, hemorrhagic events, and gastrointestinal perforation and fistula
* History of recurrence or presence of any other tumor subtype in the target lesion
* Concurrent presence of a malignant lesion within 100 mm of the target lesion that will require treatment during the study
* Current enrollment in any other investigational drug or device study within 60 days of Day 1 of this study
* Evidence of dermatological disease or confounding dermatological condition that would hinder carrying out the study or interpreting the results (eg, atopic dermatitis, eczema, psoriasis, xeroderma pigmentosa, etc.)
|
NCT_ID
NCT04470726
|
Study_NameSafety and Efficacy of AIV001 on Low Risk Basal Cell Carcinoma
| 860 |
Study Objectives
This is a single center, open-label, phase I trial with a standard 3+3 dose escalation schema to identify the maximum tolerated dose (MTD) of selinexor when combined with ICE. Once MTD is determined, there will be an expansion phase and tumor biopsies and peripheral blood will be taken pre and post selinexor to examine the study's biologic objectives.
Conditions: Peripheral T-cell Lymphoma
Intervention / Treatment:
DRUG: Selinexor, DRUG: ICE Chemotherapy
Location: Singapore
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 histologically confirmed T or NK/T-cell lymphomas including the following histologies:
* Peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS)
* Angioimmunoblastic T-cell lymphomas (AITL)
* Anaplastic large cell lymphoma (ALCL)
* Natural-killer/T-cell lymphoma (NKTL)
* Patients must have received at least two cycles of one prior regimen administered with curative intent and one of the following:
* failed to have achieve at least a partial response after 2 or more cycles
* failed to achieve a complete response after 6 or more cycles
* progressed after an initial response
* For patients who have CD30+ anaplastic large cell lymphoma, they must have failed or are ineligible or intolerant of brentuximab vedotin
* Patients must be age >18 years.
* Patients must have at least one site of measurable disease, 1.5 cm in diameter or greater.
* Patients must have ECOG performance status of 0 <= age <= 2
* Patients must have laboratory test results within these ranges:
* Absolute neutrophil count >=1500/mm³
* Platelet count >=75,000/mm³
* Creatinine clearance >=40ml/min
* Total bilirubin <=1.5x ULN. Higher levels are acceptable if these can be attributed to active haemolysis or ineffective erythropoiesis.
* AST (SGOT) and ALT (SGPT) <=2x ULN
* Women of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test prior to KPT-330 treatment. Male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential.
* Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal.
* For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose.
As the effects of selinexor on the developing human fetus at the recommended therapeutic dose are unknown, 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 selinexor. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women that are pregnant or breastfeeding are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.
* Patients must be able to understand and willing to sign a written informed consent document.
* Patients must be able to adhere to the study visit schedule and other protocol requirements.
* Patients must not have any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
* Patients must not have any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Exclusion Criteria:
* Patients who have had prior malignancies (other than T and NK/T-cell lymphomas) for <=5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
* Patients who have had other anti-cancer therapy, including radiation or experimental drug or therapy, within 28 days of enrollment.
* Patients with known HIV, active hepatitis B, active hepatitis C.
* Patients with known central nervous system involvement by lymphoma.
* Patients with known or suspected hypersensitivity to selinexor.
Inclusion of Women and Minorities:
Men and women of all ethnic groups are eligible for this study
|
NCT_ID
NCT03212937
|
Study_NamePhase I Trial of Selinexor (KPT-330) and Ifosfamide, Carboplatin, Etoposide (ICE) in Peripheral T-cell Lymphoma
| 15,795 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.