A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)
Start Date
7/17/2018
Completion Date
6/30/2028
Summary
This is a randomized, Phase 3, double-blind, placebo-controlled study of pazopanib plus abexinostat versus pazopanib plus placebo in patients with locally advanced unresectable or metastatic renal cell carcinoma (RCC).
Detailed Description
In this randomized, Phase 3, double-blind, placebo-controlled study, patients will be randomized 2:1 to receive either a combination of pazopanib plus abexinostat or pazopanib plus placebo. At the time of disease progression, patient treatment assignment will be unblinded, and those patients randomized to the pazopanib plus placebo treatment arm will have the option of crossing over to receive treatment with a combination of pazopanib plus abexinostat. After providing written informed consent, patients will be screened for study eligibility within 28 days before their first dose of study drug. After screening assessments, patients who are eligible for inclusion in the study will be randomized and receive their first dose of study drug on Cycle 1 Day 1 (C1D1), within 7 days of randomization. A treatment cycle is 28 days in length. Patients may continue to receive study drug until any of the following events: the development of IRC-verified radiographic progression as assessed by RECIST version 1.1, clinical disease progression, unacceptable toxicity, another discontinuation criterion is met, withdrawal of consent, or closure of the study by the sponsor. No maximum duration of therapy has been set.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Pazopanib
Abexinostat
Placebo
Conditions
Locations
University Of UA Cancer Center(UACC)/DH-SJHMC
Phoenix, Arizona 85004
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
UCSF Helen Diller Family Comphrensive Cancer Center - Hemato
San Francisco, California 94158
United States
Norton Cancer Institute, Norton Healthcare Pavilion
Louisville, Kentucky 40202
United States
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United States
GU Research Network/Urology Cancer Center
Omaha, Nebraska 68130
United States
Nebraska Cancer Specialists
Omaha, Nebraska 68130
United States
Northwell Health/Monter Cancer Center
Lake Success, New York 11042
United States
Mainstreet Physicans Care
Rochester, New York 14642
United States
Precision Cancer Research/Dayton Physicians Network - Treatment
Kettering, Ohio 45409
United States
Oregon Health and Science University
Portland, Oregon 97239
United States
St. Luke's Hospital
Easton, Pennsylvania 18045
United States
HOPE Cancer Center of East Texas
Tyler, Texas 75701
United States
Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane, Washington 99208
United States
Beijing Cancer Hospital
Beijing, 100142
China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, 200032
China
Fondazione del Piemonte per l'Oncologia_Istituto di Candiolo, IRCCS_ Oncologia Medica
Candiolo, 10060
Italy
A.O. Cannizzaro_UOS Oncologia Medica
Catania, 95126
Italy
IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) UO Oncologia Medica
Meldola (FC), 47014
Italy
Istituto Europeo di Oncologia_Unità Oncologia Medica Urogenitale e Cervico Facciale
Milan, 20141
Italy
Istituto Nazionale dei Tumori-Fondazione Pascale- SC Oncologia Medica
Naples, 80131
Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità Novara_SC Oncologia Medica
Novara, 28100
Italy
Istituti Clinici Scientifici Maugeri Spa-SB_ UO Oncologia Medica
Pavia, 27100
Italy
Azienda Ospedaliero Universitaria Pisana_ UO Oncologia Medica Universitaria
Pisa, 56126
Italy
Fondazione Policlinico Universitario A. Gemelli, U.O.C. Oncologia Medica
Roma, '00168
Italy
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny
Brzozów, 36-200
Poland
Szpitale Pomorskie Sp. z o.o. Oddział Onkologii i Radioterapii
Gdynia, 81-519
Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. Oddział Onkologii Klinicznej z Pododdziałem Dziennym
Krakow, 31-826
Poland
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
Poznan, 60-848
Poland
National Cancer Center - Center For Prostate Cancer
Goyang-si, 10408
South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, 13496
South Korea
Severance Hospital, Yonsei University Health System - Medical Oncology
Seoul, 03722
South Korea
Asan Medical Center - University of Ulsan College of Medicin
Seoul, 05505
South Korea
Samsung Medical Center - Hematology-Oncology
Seoul, 06351
South Korea
H.G.U. de Elche
Elche, 03203
Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
H.U. Virgen de la Victoria
Málaga, 29010
Spain