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A Study to Compare Tivozanib ...

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

Last Updated: 2023-07-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-24

Study Completion Date

2021-06-21

Brief Summary

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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 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.

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Detailed Description

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Conditions

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Carcinoma, Renal Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tivozanib hydrochloride

Participants randomized to this arm will receive the study drug, tivozanib hydrochloride.

Group Type EXPERIMENTAL

Tivozanib hydrochloride

Intervention Type DRUG

Tivozanib hydrochloride

Sorafenib

Participants randomized to this arm will receive the comparator drug, sorafenib.

Group Type ACTIVE_COMPARATOR

Sorafenib

Intervention Type DRUG

Sorafenib

Interventions

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Tivozanib hydrochloride

Intervention Type DRUG

Sorafenib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Of UA Cancer Center(UACC)/DH-SJHMC

Phoenix, Arizona, United States

Site Status

Arizona Oncology Associates, PC - HAL

Phoenix, Arizona, United States

Site Status

Arizona Oncology - Phoenix - Deer Valley Women's Center Loca

Phoenix, Arizona, United States

Site Status

Arizona Oncology - Scottsdale

Scottsdale, Arizona, United States

Site Status

City of Hope Comprehensive Breast Cancer Center

Duarte, California, United States

Site Status

Long Beach Memorial Medical Center

Fountain Valley, California, United States

Site Status

Marin Cancer Care

Greenbrae, California, United States

Site Status

UCLA

Los Angeles, California, United States

Site Status

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Site Status

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Investigative Clinical Research of Indiana

Indianapolis, Indiana, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status

Midwest Cancer Center

Omaha, Nebraska, United States

Site Status

Urology Cancer Center, PC

Omaha, Nebraska, United States

Site Status

Comprehensive Cancer Center Of Nevada

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Center Of Nevada

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Center of Nevada

Las Vegas, Nevada, United States

Site Status

Hackensack University Medical Center - John Theurer Cancer

Hackensack, New Jersey, United States

Site Status

New York Oncology Hematology, P.C.

Albany, New York, United States

Site Status

New York Oncology Hematology, PC

Albany, New York, United States

Site Status

New York Oncology Hematology, P.C.

Clifton Park, New York, United States

Site Status

New York Presbyterian Hospital

New York, New York, United States

Site Status

Columbia University Medical Center - Herbert Irving Pavilion

New York, New York, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Wake Forest University Baptist Medical Center (WFUBMC)

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Ohio Cancer Specialists

Mansfield, Ohio, United States

Site Status

North Coast Cancer Care, Inc

Sandusky, Ohio, United States

Site Status

Wooster Specialty and Surgery Center

Wooster, Ohio, United States

Site Status

St. Luke University Health Network

Easton, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, United States

Site Status

Texas Oncology - Austin Midtown

Austin, Texas, United States

Site Status

Texas Oncology-Central Austin Cancer Center

Austin, Texas, United States

Site Status

Texas Oncology - South Austin Cancer Center

Austin, Texas, United States

Site Status