A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC)

Completed · Phase 3

Conditions studied: Carcinoma, Renal Cell

In brief

This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in participants with refractory advanced renal cell carcinoma (RCC). Participants will be randomized (1:1) to treatment with tivozanib or sorafenib. Participants 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 participants 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) analyses are also included in study.

Key facts

Study ID

NCT02627963

Run by

AVEO Pharmaceuticals, Inc.

People needed

350

Starts

2016-05-24

Expected to finish

2021-06-21

Last updated by the study team

2023-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or older
• Participants 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 (participants 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.

You may not qualify if…

• 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. Participants 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.

Where it is running

• Arizona Oncology Associates, PC - HAL — Phoenix, Arizona, United States
• Arizona Oncology - Phoenix - Deer Valley Women's Center Loca — Phoenix, Arizona, United States
• Arizona Oncology - Scottsdale — Scottsdale, Arizona, United States
• City of Hope Comprehensive Breast Cancer Center — Duarte, California, United States
• Long Beach Memorial Medical Center — Fountain Valley, California, United States
• Marin Cancer Care — Greenbrae, California, United States
• UCLA — Los Angeles, California, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Investigative Clinical Research of Indiana — Indianapolis, Indiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• Midwest Cancer Center — Omaha, Nebraska, United States
• Urology Cancer Center, PC — Omaha, Nebraska, United States
• Comprehensive Cancer Center Of Nevada — Henderson, Nevada, United States
• Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
• Comprehensive Cancer Center Of Nevada — Las Vegas, Nevada, United States
• Comprehensive Cancer Center of Nevada — Las Vegas, Nevada, United States
• Hackensack University Medical Center - John Theurer Cancer — Hackensack, New Jersey, United States
• New York Oncology Hematology, P.C. — Albany, New York, United States
• University Of UA Cancer Center(UACC)/DH-SJHMC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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