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

June 27, 2023 updated by: AVEO Pharmaceuticals, Inc.

A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tivozanib hydrochloride
Participants randomized to this arm will receive the study drug, tivozanib hydrochloride.
Drug: Tivozanib hydrochloride
Tivozanib hydrochloride
Active Comparator: Sorafenib
Participants randomized to this arm will receive the comparator drug, sorafenib.
Drug: Sorafenib
Sorafenib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (up to approximately 5 years)
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Date of randomization to date of death (up to approximately 5 years)
The OS is defined as the time from the date of randomization to date of death due to any cause.
Date of randomization to date of death (up to approximately 5 years)
Objective Response Rate (ORR)
Time Frame: Every 8 weeks from date of randomization until disease progression (up to approximately 5 years)
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).
Every 8 weeks from date of randomization until disease progression (up to approximately 5 years)
Duration of Response (DOR)
Time Frame: Assessed every 8 weeks from date of randomization until date of progression (up to approximately 5 years)
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.
Assessed every 8 weeks from date of randomization until date of progression (up to approximately 5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AVEO Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2016

Primary Completion (Actual)

October 4, 2018

Study Completion (Actual)

June 21, 2021

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

December 10, 2015

First Posted (Estimated)

December 11, 2015

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AV-951-15-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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