A Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced RCC
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|ClinicalTrials.gov Identifier: NCT02627963|
Recruitment Status : Completed
First Posted : December 11, 2015
Results First Posted : February 20, 2020
Last Update Posted : January 26, 2022
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This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC).
Subjects will be randomized (1:1) to treatment with tivozanib or sorafenib.
Subjects will be stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior checkpoint inhibitor [programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L) inhibitor] plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent).
All subjects will be evaluated for progression free survival, overall survival, objective response rate, and the duration of response as well as safety and tolerability.
Pharmacokinetic (PK) analysis are also included in study.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Renal Cell||Drug: tivozanib hydrochloride Drug: Sorafenib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||June 2021|
Experimental: Tivozanib hydrochloride
Patients randomized to this arm will receive the study drug, tivozanib hydrochloride.
Drug: tivozanib hydrochloride
Active Comparator: Sorafenib
Patients randomized to this arm will receive the comparator drug, sorafenib.
- Progression-free Survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks. ]Progression-Free Survival (PFS), as assessed by a blinded independent radiological review (IRR), is defined as the time from randomization to first documentation of objective tumor progression (progressive disease) or death due to any reasons whichever comes first. Disease progression per RECIST 1.1 criteria is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Overall Survival (OS) [ Time Frame: Date of randomization to date of death ]Overall survival (OS) is defined as the time from the date of randomization to date of death due to any cause.
- Objective Response Rate (ORR) [ Time Frame: Every 8 weeks from date of randomization until disease progression ]Objective response rate (ORR) is defined as the percentage of subjects who have at least a 30% reduction in the sum of diameters per RECIST (Version 1.1).
- Duration of Response (DOR) [ Time Frame: Assessed every 8 weeks from date of randomization until date of progression ]Duration of response (DOR) is defined as the time from the first documentation of objective tumor response to the first documentation of tumor progression per RECIST 1.1 or to death due to any cause.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 18 years or older
- Subjects with metastatic RCC who have failed 2 or 3 prior systemic regimens, one of which includes a VEGFR TKI other than sorafenib or tivozanib.
- 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, and unclassified RCC are excluded).
- Measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria Version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 3 months.
- Prior treatment with sorafenib or tivozanib.
- More than 3 prior regimens for metastatic RCC.
- Known central nervous system (CNS) metastases other than stable, treated brain metastases. Subjects with previously treated brain metastasis will be allowed if the brain metastasis has been stable by neuroimaging without steroid treatment for at least 3 months following prior treatment (radiotherapy or surgery).
- Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders.
- Significant serum chemistry abnormalities
- Significant cardiovascular disease, including: Active clinically symptomatic left ventricular failure,uncontrolled hypertension, myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug, history of serious ventricular arrhythmia, cardiac arrhythmias requiring anti-arrhythmic medications.
- Inadequate recovery from any prior surgical procedure or major surgical procedure within 4 weeks prior to administration of first dose of study drug.
- Currently active second primary malignancy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627963
Documents provided by AVEO Pharmaceuticals, Inc.:
|Responsible Party:||AVEO Pharmaceuticals, Inc.|
|Other Study ID Numbers:||
|First Posted:||December 11, 2015 Key Record Dates|
|Results First Posted:||February 20, 2020|
|Last Update Posted:||January 26, 2022|
|Last Verified:||January 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action