A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC)
Public ClinicalTrials.gov record NCT02627963. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02627963
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 350 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 24, 2016 (Actual)
- Primary completion
- Oct 4, 2018 (Actual)
- Completion
- Jun 21, 2021 (Actual)
- Last update posted
- Jul 18, 2023
2016 – 2021
United States locations
- U.S. sites
- 56
- U.S. states
- 16
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Of UA Cancer Center(UACC)/DH-SJHMC | Phoenix | Arizona | 85004 | — |
| Arizona Oncology Associates, PC - HAL | Phoenix | Arizona | 85016 | — |
| Arizona Oncology - Phoenix - Deer Valley Women's Center Loca | Phoenix | Arizona | 85027 | — |
| Arizona Oncology - Scottsdale | Scottsdale | Arizona | 85258 | — |
| City of Hope Comprehensive Breast Cancer Center | Duarte | California | 91010 | — |
| Long Beach Memorial Medical Center | Fountain Valley | California | 92708 | — |
| Marin Cancer Care | Greenbrae | California | 94904 | — |
| UCLA | Los Angeles | California | 90095 | — |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Investigative Clinical Research of Indiana | Indianapolis | Indiana | 46260 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | — |
| Midwest Cancer Center | Omaha | Nebraska | 68130 | — |
| Urology Cancer Center, PC | Omaha | Nebraska | 68130 | — |
| Comprehensive Cancer Center Of Nevada | Henderson | Nevada | 89052 | — |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89074 | — |
| Comprehensive Cancer Center Of Nevada | Las Vegas | Nevada | 89128 | — |
| Comprehensive Cancer Center of Nevada | Las Vegas | Nevada | 89148 | — |
| Hackensack University Medical Center - John Theurer Cancer | Hackensack | New Jersey | 07601 | — |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | — |
| New York Oncology Hematology, PC | Albany | New York | 12208 | — |
| New York Oncology Hematology, P.C. | Clifton Park | New York | 12065 | — |
| New York Presbyterian Hospital | New York | New York | 10021 | — |
| Columbia University Medical Center - Herbert Irving Pavilion | New York | New York | 10032 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Wake Forest University Baptist Medical Center (WFUBMC) | Winston-Salem | North Carolina | 27157 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Ohio Cancer Specialists | Mansfield | Ohio | 44906 | — |
| North Coast Cancer Care, Inc | Sandusky | Ohio | 44870 | — |
| Wooster Specialty and Surgery Center | Wooster | Ohio | 44691 | — |
| St. Luke University Health Network | Easton | Pennsylvania | 18045 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| University of Pittsburgh Medical Center (UPMC) | Pittsburgh | Pennsylvania | 15232 | — |
| Texas Oncology - Austin Midtown | Austin | Texas | 78705 | — |
| Texas Oncology-Central Austin Cancer Center | Austin | Texas | 78731 | — |
| Texas Oncology - South Austin Cancer Center | Austin | Texas | 78745 | — |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| Texas Oncology - Fort Worth 12th Ave | Fort Worth | Texas | 76104 | — |
| Texas Oncology SW Fort Worth Cancer Center | Fort Worth | Texas | 76132 | — |
| Arizona Oncology Associates, PC - HAL | Fort Worth | Texas | 76177 | — |
| Comprehensive Cancer Centers of Nevada (CCCN) | Fort Worth | Texas | 76177 | — |
| Comprehensive Cancer Centers of Nevada | Fort Worth | Texas | 76177 | — |
| Nebraska Cancer Specialists (NCS) - Midwest Cancer Center | Fort Worth | Texas | 76177 | — |
| Texas Oncology - El Paso Cancer Treatment Center | Fort Worth | Texas | 76177 | — |
| Texas Oncology-El Paso Cancer Treatment Center | Fort Worth | Texas | 76177 | — |
| Texas Oncology-Garland | Garland | Texas | 75042 | — |
| Baylor College of Medicine - Baylor Clinic | Houston | Texas | 77030 | — |
| Texas Oncology - Longview Cancer Center | Longview | Texas | 75601 | — |
| Texas Oncology, P.A. | Plano | Texas | 75093 | — |
| Texas Oncology - Tyler | Tyler | Texas | 75702 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 135 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02627963, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 18, 2023 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02627963 live on ClinicalTrials.gov.