EUCTR2015-003607-30-FRActive, not recruitingPhase 1
A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- AVEO PHARMACEUTICALS, INC.
- Enrollment
- 322
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. = 18-years of age.
- •2. Subjects with recurrent metastatic RCC who have failed 2 or 3 prior systemic regimens, one of which includes a VEGFR TKI other than sorafenib or tivozanib.
- •3. Subjects must have recovered from the AEs of prior therapy or returned to baseline, and be off all therapy for at least 2 weeks.
- •4. Histologically or cytologically confirmed RCC with a clear cell component (subjects with pure papillary cell tumor or other non-clear cell histologies, including collecting duct, medullary, chromophobe, mixed tumor containing predominantly sarcomatoid cells, and unclassified RCC are excluded).
- •5. Measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria Version 1.1.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •7. Life expectancy = 3 months.
- •8. If female and of childbearing potential, documentation of negative pregnancy test prior to enrollment.
- •9. Ability to give written informed consent and comply with protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 161
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 161
Exclusion Criteria
- •1. Prior treatment with sorafenib or tivozanib.
- •2. More than 3 prior regimens for metastatic RCC.
- •3. Known central nervous system (CNS) diseases other than stable, treated brain metastases, defined as primary CNS malignancies or CNS metastases
- •4. Significant cardiovascular disease
- •5. Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug
- •6. Significant bleeding disorders
- •7. Currently active second primary malignancy
- •8. Pregnant or lactating females.
- •9. Participation in another interventional protocol.
Investigators
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