search
Back to results

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

Primary Purpose

Carcinoma, Renal Cell

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tivozanib hydrochloride
Sorafenib
Sponsored by
AVEO Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

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. 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.

Sites / Locations

  • University Of UA Cancer Center(UACC)/DH-SJHMC
  • Arizona Oncology Associates, PC - HAL
  • Arizona Oncology - Phoenix - Deer Valley Women's Center Loca
  • Arizona Oncology - Scottsdale
  • City of Hope Comprehensive Breast Cancer Center
  • Long Beach Memorial Medical Center
  • Marin Cancer Care
  • UCLA
  • MedStar Georgetown University Hospital
  • Mount Sinai Comprehensive Cancer Center
  • University of Miami Sylvester Comprehensive Cancer Center
  • Loyola University Medical Center
  • Investigative Clinical Research of Indiana
  • Beth Israel Deaconess Medical Center
  • Karmanos Cancer Institute
  • Henry Ford Health System
  • Nebraska Methodist Hospital
  • Midwest Cancer Center
  • Urology Cancer Center, PC
  • Comprehensive Cancer Center Of Nevada
  • Comprehensive Cancer Centers of Nevada
  • Comprehensive Cancer Center Of Nevada
  • Comprehensive Cancer Center of Nevada
  • Hackensack University Medical Center - John Theurer Cancer
  • New York Oncology Hematology, P.C.
  • New York Oncology Hematology, PC
  • Montefiore Medical Center
  • New York Oncology Hematology, P.C.
  • New York Presbyterian Hospital
  • Columbia University Medical Center - Herbert Irving Pavilion
  • University of Rochester Medical Center
  • Wake Forest University Baptist Medical Center (WFUBMC)
  • Cleveland Clinic
  • Ohio Cancer Specialists
  • North Coast Cancer Care, Inc
  • Wooster Specialty and Surgery Center
  • St. Luke University Health Network
  • Fox Chase Cancer Center
  • University of Pittsburgh Medical Center (UPMC)
  • Texas Oncology - Austin Midtown
  • Texas Oncology-Central Austin Cancer Center
  • Texas Oncology - South Austin Cancer Center
  • Texas Oncology - Baylor Charles A. Sammons Cancer Center
  • Texas Oncology - Fort Worth 12th Ave
  • Texas Oncology SW Fort Worth Cancer Center
  • Arizona Oncology Associates, PC - HAL
  • Comprehensive Cancer Centers of Nevada (CCCN)
  • Comprehensive Cancer Centers of Nevada
  • Nebraska Cancer Specialists (NCS) - Midwest Cancer Center
  • Texas Oncology - El Paso Cancer Treatment Center
  • Texas Oncology-El Paso Cancer Treatment Center
  • Texas Oncology-Garland
  • Baylor College of Medicine - Baylor Clinic
  • Texas Oncology - Longview Cancer Center
  • Texas Oncology, P.A.
  • Texas Oncology - Tyler
  • UZ Antwerpen
  • Institut Jules Bordet
  • Grand Hôpital de Charleroi - Site Notre-Dame
  • CHU Ambroise Paré
  • Jessa Ziekenhuis - Campus Virga Jesse
  • CHU Dinant Godinne UCL Namur
  • UZ Gent
  • AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan
  • British Columbia Cancer Agency (BCCA)
  • Dr. Leon Richard Oncology Centre
  • London Health Sciences Center
  • Sunnybrook
  • Masarykuv onkologicky ustav
  • FN Hradec Kralove
  • Fakultni nemocnice Olomouc
  • Fakultni nemocnice u sv. Anny v Brne
  • Fakultni nemocnice v Motole
  • Herlev Hospital
  • Aarhus Universitetshospital
  • Odense Universitetshospital
  • Hopital Saint-André
  • CHRU de Tours - Hopital Bretonneau TOURS
  • Institut de Cancerologie de la Loire
  • Institut de Cancérologie de l'Ouest Site Paul Papin
  • Institut de cancérologie de Lorraine
  • centre Oscar Lambret
  • Clinique Victor Hugo
  • Institut Paoli-Calmettes
  • Chu De Poitiers
  • ICO
  • Institut Gustave Roussy
  • Universitätsklinikum Freiburg
  • Univesitaetsklinik Heidelberg
  • Kliniken Nordoberpfalz AG, Klinikum Weiden
  • Johann Wolfgang Goethe Universität
  • Evangelisches Krankenhaus Bielefeld
  • SZB Study Center University Hospital Bonn
  • Uniklinik Köln Klinik und Poliklinik für Urologie
  • Universitätsklinikum des Saarlandes
  • Universitätsklinikum Carl Gustav Carus
  • Jena University Hospital
  • Universitätsklinikum Aachen
  • Universitätsklinikum Hamburg-Eppendorf
  • Medizinische Hochschule Hannover
  • Universitaetsklinikum Muenster
  • Universität Tübingen
  • Pécsi Tudományegyetem Klinikai Központ
  • Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
  • Békés Megyei Pándy Kálmán Kórház
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo
  • Debreceni Egyetem Klinikai Központ
  • Szent Margit Kórház
  • Magyar Honvédség Egészségügyi Központ
  • Semmelweis Egyetem
  • Semmelweis Egyetem
  • Országos Onkológiai Intézet
  • Egyesített Szent István és Szent László Kórház-Rendelőintéze
  • Somogy Megyei Kaposi Mór Oktató Kórház
  • Markusovszky Egyetemi Oktatókórház
  • Zala Megyei Korhaz
  • Casa Sollievo della Sofferenza, IRCCS
  • Irccs Irst
  • Istituto Clinico Humanitas Rozzano, IRCCS
  • Usl 7 Siena - Ospedale Alta Valdelsa ASL TOSCANA SUD-EST
  • Istituto di Candiolo, IRCCS
  • Ospedale S.Donato, AUSL 8 di Arezzo
  • Centro di Riferimento Oncologico IRCCS
  • AO Spedali Civili di Brescia, PO Spedali Civili
  • P.O. Ss. Annunziata
  • ASST-Istituti Ospitalieri di Cremona, AO di Cremona
  • AOU Careggi
  • IRCCS AOU San Martino-IST Istituto Nazionale per la Ricerca
  • Ospedale Vito Fazzi, ASL Lecce
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Ieo, Irccs
  • AOU Policlinico di Modena
  • IRCCS Fondazione "Giovanni Pascale"
  • Istituto Oncologico Veneto IOV-IRCCS
  • IRCCS Policlinico San Matteo
  • PU Campus Bio-medico di Roma
  • Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS
  • Azienda Ospedaliera San Camillo Forlanini
  • Azienda Ospedaliera S. Maria di Terni
  • Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
  • Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie
  • MAGODENT Sp. z o.o. Szpital Onkologiczno-Kardiologiczny
  • Szpital Specjalist w Brzozowie Podkarpacki Ośrodek Onkologiczny
  • COPERNICUS Podmiot Leczn. Sp z o.o.,Wojew. Centrum Onkologii
  • NZOZ Vesalius Sp. z o.o.
  • Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
  • H.G.U. de Elche
  • H.U.Son Espases
  • Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
  • Institut Catalá d´Oncología (I.C.O.)
  • C.S. Parc Taulí
  • H.U.F. Alcorcón
  • H.U.P Hierro-Majadahonda
  • C.H. de Navarra
  • H.del Mar
  • H.Sta.Creu i St.Pau
  • H.U.Vall d'Hebrón
  • H. Clinic de Barcelona
  • H.U. Reina Sofía
  • ICO-H.U.Dr.J.Trueta
  • C.H. de Jaén
  • H.G.U. G. Marañón
  • H.U. Infanta Leonor
  • Hospital Universitario Ramón y Cajal
  • H.C. S.Carlos
  • H.U. F. Jiménez Díaz
  • H.U. 12 de Octubre
  • H.U. La Paz
  • H. Madrid Norte Sanchinarro
  • H.U. Virgen de la Victoria
  • H.U.V. Macarena
  • F.I. Valenciano de Oncología
  • H.U.P.La Fe
  • H.U. Miguel Servet
  • Addenbrooke's Hospital
  • Beatson West Of Scotland Cancer Centre
  • Cheltenham General Hospital
  • Southampton University Hospitals Nhs Trust
  • East Lancashire Hospitals NHS Trust
  • Lancashire Teaching Hospitals NHS Foundation Trust
  • Royal Stroke Center
  • The Royal Marsden NHS Foundation Trust
  • St James's University Hospital / Leeds Teaching Hospitals
  • The Royal Marsden NHS Foundation Trust
  • Charing Cross Hospital
  • The Christie NHS Foundation Trust
  • Mount Vernon Cancer Care
  • Nottingham University Hospitals NHS Trust - City Hospital
  • Churchill Hospital [Oncology]
  • Singleton Hospital
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tivozanib hydrochloride

Sorafenib

Arm Description

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

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

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
The 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.

Secondary Outcome Measures

Overall Survival (OS)
The OS is defined as the time from the date of randomization to date of death due to any cause.
Objective Response Rate (ORR)
The ORR is defined as the percentage of participants who have at least a 30% reduction in the sum of diameters per RECIST (Version 1.1).
Duration of Response (DOR)
The 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.

Full Information

First Posted
December 9, 2015
Last Updated
June 27, 2023
Sponsor
AVEO Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02627963
Brief Title
A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC)
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 24, 2016 (Actual)
Primary Completion Date
October 4, 2018 (Actual)
Study Completion Date
June 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AVEO Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tivozanib hydrochloride
Arm Type
Experimental
Arm Description
Participants randomized to this arm will receive the study drug, tivozanib hydrochloride.
Arm Title
Sorafenib
Arm Type
Active Comparator
Arm Description
Participants randomized to this arm will receive the comparator drug, sorafenib.
Intervention Type
Drug
Intervention Name(s)
Tivozanib hydrochloride
Intervention Description
Tivozanib hydrochloride
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
Sorafenib
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
The 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.
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 (up to approximately 5 years)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
The OS is defined as the time from the date of randomization to date of death due to any cause.
Time Frame
Date of randomization to date of death (up to approximately 5 years)
Title
Objective Response Rate (ORR)
Description
The ORR is defined as the percentage of participants who have at least a 30% reduction in the sum of diameters per RECIST (Version 1.1).
Time Frame
Every 8 weeks from date of randomization until disease progression (up to approximately 5 years)
Title
Duration of Response (DOR)
Description
The 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.
Time Frame
Assessed every 8 weeks from date of randomization until date of progression (up to approximately 5 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University Of UA Cancer Center(UACC)/DH-SJHMC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Arizona Oncology Associates, PC - HAL
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Arizona Oncology - Phoenix - Deer Valley Women's Center Loca
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Arizona Oncology - Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
City of Hope Comprehensive Breast Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Long Beach Memorial Medical Center
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Marin Cancer Care
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Investigative Clinical Research of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Midwest Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Urology Cancer Center, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Comprehensive Cancer Center Of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Comprehensive Cancer Center Of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Comprehensive Cancer Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Hackensack University Medical Center - John Theurer Cancer
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
New York Oncology Hematology, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Clifton Park
State/Province
New York
ZIP/Postal Code
12065
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia University Medical Center - Herbert Irving Pavilion
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Wake Forest University Baptist Medical Center (WFUBMC)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio Cancer Specialists
City
Mansfield
State/Province
Ohio
ZIP/Postal Code
44906
Country
United States
Facility Name
North Coast Cancer Care, Inc
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Facility Name
Wooster Specialty and Surgery Center
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
St. Luke University Health Network
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Pittsburgh Medical Center (UPMC)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Texas Oncology - Austin Midtown
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Oncology-Central Austin Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Oncology - South Austin Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Texas Oncology - Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology - Fort Worth 12th Ave
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Oncology SW Fort Worth Cancer Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Arizona Oncology Associates, PC - HAL
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada (CCCN)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
Nebraska Cancer Specialists (NCS) - Midwest Cancer Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
Texas Oncology - El Paso Cancer Treatment Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
Texas Oncology-El Paso Cancer Treatment Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
Texas Oncology-Garland
City
Garland
State/Province
Texas
ZIP/Postal Code
75042
Country
United States
Facility Name
Baylor College of Medicine - Baylor Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology - Longview Cancer Center
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Name
Texas Oncology, P.A.
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
UZ Antwerpen
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Institut Jules Bordet
City
Bruxelles
State/Province
Brussels Capital Region
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Grand Hôpital de Charleroi - Site Notre-Dame
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Facility Name
CHU Ambroise Paré
City
Mons
State/Province
Hainaut
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Jessa Ziekenhuis - Campus Virga Jesse
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Facility Name
CHU Dinant Godinne UCL Namur
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Facility Name
UZ Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
British Columbia Cancer Agency (BCCA)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Dr. Leon Richard Oncology Centre
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Sunnybrook
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Name
Masarykuv onkologicky ustav
City
Brno
State/Province
Brno-město
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
FN Hradec Kralove
City
Hradec Kralove
State/Province
Královéhradecký Kraj
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
State/Province
Olomoucký Kraj
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultni nemocnice u sv. Anny v Brne
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Herlev Hospital
City
Herlev
State/Province
Capital
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Aarhus Universitetshospital
City
Aarhus C
State/Province
Central Jutland
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense
State/Province
South Denmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Hopital Saint-André
City
Bordeaux Cedex
State/Province
Gironde
ZIP/Postal Code
33075
Country
France
Facility Name
CHRU de Tours - Hopital Bretonneau TOURS
City
Tours CEDEX 1
State/Province
Indre-et-Loire
ZIP/Postal Code
37000
Country
France
Facility Name
Institut de Cancerologie de la Loire
City
Saint-Priest-en-Jarez
State/Province
Loire
ZIP/Postal Code
42271
Country
France
Facility Name
Institut de Cancérologie de l'Ouest Site Paul Papin
City
Angers
State/Province
Maine-et-Loire
ZIP/Postal Code
49000
Country
France
Facility Name
Institut de cancérologie de Lorraine
City
Vandoeuvre Les Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54519
Country
France
Facility Name
centre Oscar Lambret
City
Lille
State/Province
Nord-Pas-de-Calais
ZIP/Postal Code
59020
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
State/Province
Pays-de-la-Loire
ZIP/Postal Code
72000
Country
France
Facility Name
Institut Paoli-Calmettes
City
Marseille Cedex 09
ZIP/Postal Code
13273
Country
France
Facility Name
Chu De Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
ICO
City
Saint Herblain CEDEX
ZIP/Postal Code
44805
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Univesitaetsklinik Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Kliniken Nordoberpfalz AG, Klinikum Weiden
City
Weiden
State/Province
Bayern
ZIP/Postal Code
92637
Country
Germany
Facility Name
Johann Wolfgang Goethe Universität
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Evangelisches Krankenhaus Bielefeld
City
Bielefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33611
Country
Germany
Facility Name
SZB Study Center University Hospital Bonn
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
D-53127
Country
Germany
Facility Name
Uniklinik Köln Klinik und Poliklinik für Urologie
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
1307
Country
Germany
Facility Name
Jena University Hospital
City
Jena
State/Province
Thüringen
ZIP/Postal Code
7743
Country
Germany
Facility Name
Universitätsklinikum Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universität Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Pécsi Tudományegyetem Klinikai Központ
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
City
Miskolc
State/Province
Borsod-Abaúj-Zemplén
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Békés Megyei Pándy Kálmán Kórház
City
Gyula
State/Province
Békés
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo
City
Szeged
State/Province
Csongrád
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Központ
City
Debrecen
State/Province
Hajdú-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Szent Margit Kórház
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
Magyar Honvédség Egészségügyi Központ
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Országos Onkológiai Intézet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Egyesített Szent István és Szent László Kórház-Rendelőintéze
City
Budapest
ZIP/Postal Code
H-1096
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Markusovszky Egyetemi Oktatókórház
City
Szombathely
ZIP/Postal Code
H-9700
Country
Hungary
Facility Name
Zala Megyei Korhaz
City
Zalaegerszeg
ZIP/Postal Code
H-8900
Country
Hungary
Facility Name
Casa Sollievo della Sofferenza, IRCCS
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Irccs Irst
City
Meldola
State/Province
Forli
ZIP/Postal Code
47014
Country
Italy
Facility Name
Istituto Clinico Humanitas Rozzano, IRCCS
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Usl 7 Siena - Ospedale Alta Valdelsa ASL TOSCANA SUD-EST
City
Poggibonsi
State/Province
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Istituto di Candiolo, IRCCS
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Facility Name
Ospedale S.Donato, AUSL 8 di Arezzo
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Centro di Riferimento Oncologico IRCCS
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
AO Spedali Civili di Brescia, PO Spedali Civili
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
P.O. Ss. Annunziata
City
Chieti
ZIP/Postal Code
66013
Country
Italy
Facility Name
ASST-Istituti Ospitalieri di Cremona, AO di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
AOU Careggi
City
Firenze
Country
Italy
Facility Name
IRCCS AOU San Martino-IST Istituto Nazionale per la Ricerca
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale Vito Fazzi, ASL Lecce
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Ieo, Irccs
City
Milano
Country
Italy
Facility Name
AOU Policlinico di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
IRCCS Fondazione "Giovanni Pascale"
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Oncologico Veneto IOV-IRCCS
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
PU Campus Bio-medico di Roma
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS
City
Roma
ZIP/Postal Code
144
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
ZIP/Postal Code
151
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria di Terni
City
Terni
ZIP/Postal Code
5100
Country
Italy
Facility Name
Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
City
Otwock
State/Province
Mazowieckie
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
MAGODENT Sp. z o.o. Szpital Onkologiczno-Kardiologiczny
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
04-125
Country
Poland
Facility Name
Szpital Specjalist w Brzozowie Podkarpacki Ośrodek Onkologiczny
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
COPERNICUS Podmiot Leczn. Sp z o.o.,Wojew. Centrum Onkologii
City
Gdansk
ZIP/Postal Code
80-219
Country
Poland
Facility Name
NZOZ Vesalius Sp. z o.o.
City
Krakow
ZIP/Postal Code
31-216
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
H.G.U. de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
H.U.Son Espases
City
Palma
State/Province
Baleares
ZIP/Postal Code
07010
Country
Spain
Facility Name
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Institut Catalá d´Oncología (I.C.O.)
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
C.S. Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
H.U.F. Alcorcón
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
H.U.P Hierro-Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
C.H. de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
H.del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
H.Sta.Creu i St.Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
H.U.Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
H. Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
H.U. Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
ICO-H.U.Dr.J.Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
C.H. de Jaén
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Facility Name
H.G.U. G. Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
H.U. Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
H.C. S.Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
H.U. F. Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
H.U. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
H.U. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
H. Madrid Norte Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
H.U. Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
H.U.V. Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
F.I. Valenciano de Oncología
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
H.U.P.La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
H.U. Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Beatson West Of Scotland Cancer Centre
City
Glasgow
State/Province
Glasgow City
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Cheltenham General Hospital
City
Cheltenham
State/Province
Gloucestershire
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Southampton University Hospitals Nhs Trust
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
East Lancashire Hospitals NHS Trust
City
Blackburn
State/Province
Lancashire
ZIP/Postal Code
BB2 3HH
Country
United Kingdom
Facility Name
Lancashire Teaching Hospitals NHS Foundation Trust
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Royal Stroke Center
City
Stoke-on-Trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
St James's University Hospital / Leeds Teaching Hospitals
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW36JJ
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Mount Vernon Cancer Care
City
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust - City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Churchill Hospital [Oncology]
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Singleton Hospital
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33980467
Citation
Szarek M, Needle MN, Rini BI, Pal SK, McDermott DF, Atkins MB, Hutson TE, Escudier BJ. Q-TWiST Analysis of Tivozanib Versus Sorafenib in Patients With Advanced Renal Cell Carcinoma in the TIVO-3 Study. Clin Genitourin Cancer. 2021 Oct;19(5):468.e1-468.e5. doi: 10.1016/j.clgc.2021.03.018. Epub 2021 Apr 3.
Results Reference
derived
PubMed Identifier
31810797
Citation
Rini BI, Pal SK, Escudier BJ, Atkins MB, Hutson TE, Porta C, Verzoni E, Needle MN, McDermott DF. Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study. Lancet Oncol. 2020 Jan;21(1):95-104. doi: 10.1016/S1470-2045(19)30735-1. Epub 2019 Dec 3.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs