A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pazopanib: All patients will receive pazopanib at a starting dose of 800 mg by mouth (p.o.) daily on Days 1 to 28 of each treatment cycle. Patients should be instructed to take their once- daily oral dose of pazopanib at the same time each morning. Each dose of pazopanib should be taken with an 8 oz/240 mL glass of water either 1 hour before or 2 hours after a meal. Patients should be instructed to swallow the tablets whole and not chew them.
Abexinostat: The starting dose and schedule of abexinostat will be 80 mg 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. Each dose of abexinostat should be taken with an 8 oz/240 mL glass of water at least half an hour before meals or more than 2 hours after a meal and must be 4 hours apart. Patients should be instructed to swallow the tablets whole and not chew them.
Placebo: The starting dose and schedule of abexinostat matching placebo will be 80 mg 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. Each dose of placebo should be taken with an 8 oz/240 mL glass of water at least half an hour before meals or more than 2 hours after a meal and must be 4 hours apart. Patients should be instructed to swallow the tablets whole and not chew them.
Study 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
Primary outcome measure(s)
- Progression-free survival (PFS) — From randomization date to date of first documentation of progression OR death (up to approximately 4 years).
To compare the PFS between treatment arms. PFS is defined as the time (month) interval between date of randomization and date of radiographic disease progression or death for those without prior evidence of progression, as assessed by blinded Independent Review Committee (IRC) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Trial sites (38)
| Facility | City | Region | Status |
|---|---|---|---|
| University Of UA Cancer Center(UACC)/DH-SJHMC | Phoenix | Arizona | Withdrawn |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | Withdrawn |
| UCSF Helen Diller Family Comphrensive Cancer Center - Hemato | San Francisco | California | Withdrawn |
| Norton Cancer Institute, Norton Healthcare Pavilion | Louisville | Kentucky | Completed |
| Ochsner Clinic Foundation | New Orleans | Louisiana | Completed |
| GU Research Network/Urology Cancer Center | Omaha | Nebraska | Withdrawn |
| Nebraska Cancer Specialists | Omaha | Nebraska | Completed |
| Northwell Health/Monter Cancer Center | Lake Success | New York | Withdrawn |
| Mainstreet Physicans Care | Rochester | New York | Completed |
| Precision Cancer Research/Dayton Physicians Network - Treatment | Kettering | Ohio | Withdrawn |
| Oregon Health and Science University | Portland | Oregon | Completed |
| St. Luke's Hospital | Easton | Pennsylvania | Completed |
| HOPE Cancer Center of East Texas | Tyler | Texas | Completed |
| Medical Oncology Associates, PS (dba Summit Cancer Centers) | Spokane | Washington | Withdrawn |
| Beijing Cancer Hospital | Beijing | China | Recruiting |
| Zhongshan Hospital Affiliated to Fudan University | Shanghai | China | Not Yet Recruiting |
| Fondazione del Piemonte per l'Oncologia_Istituto di Candiolo, IRCCS_ Oncologia Medica | Candiolo | Italy | Withdrawn |
| A.O. Cannizzaro_UOS Oncologia Medica | Catania | Italy | Withdrawn |
| IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) UO Oncologia Medica | Meldola (FC) | Italy | Withdrawn |
| Istituto Europeo di Oncologia_Unità Oncologia Medica Urogenitale e Cervico Facciale | Milan | Italy | Withdrawn |
| Istituto Nazionale dei Tumori-Fondazione Pascale- SC Oncologia Medica | Naples | Italy | Withdrawn |
| Azienda Ospedaliero-Universitaria Maggiore della Carità Novara_SC Oncologia Medica | Novara | Italy | Withdrawn |
| Istituti Clinici Scientifici Maugeri Spa-SB_ UO Oncologia Medica | Pavia | Italy | Withdrawn |
| Azienda Ospedaliero Universitaria Pisana_ UO Oncologia Medica Universitaria | Pisa | Italy | Withdrawn |
| Fondazione Policlinico Universitario A. Gemelli, U.O.C. Oncologia Medica | Roma | Italy | Withdrawn |
| Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny | Brzozów | Poland | Withdrawn |
| Szpitale Pomorskie Sp. z o.o. Oddział Onkologii i Radioterapii | Gdynia | Poland | Withdrawn |
| Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. Oddział Onkologii Klinicznej z Pododdziałem Dziennym | Krakow | Poland | Completed |
| Clinical Research Center Sp. z o.o., Medic-R Sp. K. | Poznan | Poland | Withdrawn |
| National Cancer Center - Center For Prostate Cancer | Goyang-si | South Korea | Completed |
| CHA Bundang Medical Center, CHA University | Seongnam-si | South Korea | Completed |
| Severance Hospital, Yonsei University Health System - Medical Oncology | Seoul | South Korea | Completed |
| Asan Medical Center - University of Ulsan College of Medicin | Seoul | South Korea | Completed |
| Samsung Medical Center - Hematology-Oncology | Seoul | South Korea | Withdrawn |
| H.G.U. de Elche | Elche | Spain | Withdrawn |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | Withdrawn |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Completed |
| H.U. Virgen de la Victoria | Málaga | Spain | Withdrawn |
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03592472 on ClinicalTrials.gov ↗ ← All trials in the USA