Find Renal Cell Carcinoma (RCC) Clinical Trials Near You
A Randomized, Phase 3, Double-blind, Placebo-controlled Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma(RENAVIV)
Who is this study for? Patients with Renal Cell Cancer
What treatments are being studied? Pazopanib
Status: Recruiting
Location: See all (38) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ To be enrolled in the study, patients will be required to meet all of the following criteria:
• Patients aged ≥ 18 years at time of study entry.
• Patients have histologically confirmed RCC with clear cell component.
• Patients have locally advanced and unresectable or metastatic disease.
• Measurable disease as assessed only by the investigator (not verified by IRC) according to RECIST version 1.1.
• Patients must not have had any prior vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor treatment in either (neo)adjuvant or locally advanced/metastatic setting. Up to 1 line of prior cytokine or immune checkpoint inhibitor treatment is allowed in either the (neo)adjuvant or metastatic setting provided screening scans indicate progressive disease (PD) during or following completion of treatment.
• Patients have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patients have adequate baseline organ function.
• Patients have adequate baseline hematologic function
• Patient must be at least 2 weeks from last systemic treatment or dose of radiation prior to date of randomization.
Locations
United States
Arizona
University Of UA Cancer Center(UACC)/DH-SJHMC
WITHDRAWN
Phoenix
California
University of California Davis Comprehensive Cancer Center
WITHDRAWN
Sacramento
UCSF Helen Diller Family Comphrensive Cancer Center - Hemato
WITHDRAWN
San Francisco
Kentucky
Norton Cancer Institute, Norton Healthcare Pavilion
COMPLETED
Louisville
Louisiana
Ochsner Clinic Foundation
COMPLETED
New Orleans
Nebraska
GU Research Network/Urology Cancer Center
WITHDRAWN
Omaha
Nebraska Cancer Specialists
COMPLETED
Omaha
New York
Northwell Health/Monter Cancer Center
WITHDRAWN
Lake Success
Mainstreet Physicans Care
COMPLETED
Rochester
Ohio
Precision Cancer Research/Dayton Physicians Network - Treatment
WITHDRAWN
Kettering
Oregon
Oregon Health and Science University
COMPLETED
Portland
Pennsylvania
St. Luke's Hospital
COMPLETED
Easton
Texas
HOPE Cancer Center of East Texas
COMPLETED
Tyler
Washington
Medical Oncology Associates, PS (dba Summit Cancer Centers)
WITHDRAWN
Spokane
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Zhongshan Hospital Affiliated to Fudan University
NOT_YET_RECRUITING
Shanghai
Italy
Fondazione del Piemonte per l'Oncologia_Istituto di Candiolo, IRCCS_ Oncologia Medica
WITHDRAWN
Candiolo
A.O. Cannizzaro_UOS Oncologia Medica
WITHDRAWN
Catania
IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) UO Oncologia Medica
WITHDRAWN
Meldola (fc)
Istituto Europeo di Oncologia_Unità Oncologia Medica Urogenitale e Cervico Facciale
WITHDRAWN
Milan
Istituto Nazionale dei Tumori-Fondazione Pascale- SC Oncologia Medica
WITHDRAWN
Naples
Azienda Ospedaliero-Universitaria Maggiore della Carità Novara_SC Oncologia Medica
Fondazione Policlinico Universitario A. Gemelli, U.O.C. Oncologia Medica
WITHDRAWN
Roma
Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny
WITHDRAWN
Brzozów
Szpitale Pomorskie Sp. z o.o. Oddział Onkologii i Radioterapii
WITHDRAWN
Gdynia
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. Oddział Onkologii Klinicznej z Pododdziałem Dziennym
COMPLETED
Krakow
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
WITHDRAWN
Poznan
Republic of Korea
National Cancer Center - Center For Prostate Cancer
COMPLETED
Goyang-si
CHA Bundang Medical Center, CHA University
COMPLETED
Seongnam-si
Asan Medical Center - University of Ulsan College of Medicin
COMPLETED
Seoul
Samsung Medical Center - Hematology-Oncology
WITHDRAWN
Seoul
Severance Hospital, Yonsei University Health System - Medical Oncology
COMPLETED
Seoul
Spain
H.G.U. de Elche
WITHDRAWN
Elche
Hospital Universitario 12 de Octubre
COMPLETED
Madrid
Hospital Universitario Fundación Jiménez Díaz
WITHDRAWN
Madrid
H.U. Virgen de la Victoria
WITHDRAWN
Málaga
Contact Information
Primary
Sophia Paspal, Ph.D.
sophia.paspal@xynomicpharma.com
6104055974
Backup
Rahul Aggarwal, M.D.
rahul.aggarwal@ucsf.edu
Time Frame
Start Date:2018-07-17
Estimated Completion Date:2028-06-30
Participants
Target number of participants:413
Treatments
Experimental: Pazopanib plus abexinostat
Randomized patients will receive a combination of pazopanib plus abexinostat. The patients will receive pazopanib by mouth (p.o.) daily on Days 1 to 28 of each treatment cycle and will receive abexinostat p.o twice daily (BID) on Days 1 to 4, 8 to 11, and 15 to 18 of every 28-day cycle, 2 doses 4 hours apart. Patients will be instructed to take their once- daily oral dose of pazopanib and BID oral dose of abexinostat at the same time each day.
Placebo_comparator: Pazopanib plus placebo
Randomized patients will receive a combination of pazopanib plus abexinostat matching placebo. The patients will receive pazopanib by mouth (p.o.) daily on Days 1 to 28 of each treatment cycle and will receive abexinostat matching placebo p.o BID on Days 1 to 4, 8 to 11, and 15 to 18 of every 28-day cycle, 2 doses 4 hours apart. Patients will be instructed to take their once- daily oral dose of pazopanib and BID oral dose of placebo at the same time each day.