A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)

PHASE3RecruitingINTERVENTIONAL
Enrollment

413

Participants

Timeline

Start Date

July 17, 2018

Primary Completion Date

December 30, 2026

Study Completion Date

June 30, 2028

Conditions
Renal Cell Carcinoma
Interventions
DRUG

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.

DRUG

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.

OTHER

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.

Trial Locations (38)

10060

WITHDRAWN

Fondazione del Piemonte per l'Oncologia_Istituto di Candiolo, IRCCS_ Oncologia Medica, Candiolo

10408

COMPLETED

National Cancer Center - Center For Prostate Cancer, Goyang-si

11042

WITHDRAWN

Northwell Health/Monter Cancer Center, Lake Success

13496

COMPLETED

CHA Bundang Medical Center, CHA University, Seongnam-si

14642

COMPLETED

Mainstreet Physicans Care, Rochester

18045

COMPLETED

St. Luke's Hospital, Easton

20141

WITHDRAWN

Istituto Europeo di Oncologia_Unità Oncologia Medica Urogenitale e Cervico Facciale, Milan

27100

WITHDRAWN

Istituti Clinici Scientifici Maugeri Spa-SB_ UO Oncologia Medica, Pavia

28040

WITHDRAWN

Hospital Universitario Fundación Jiménez Díaz, Madrid

28041

COMPLETED

Hospital Universitario 12 de Octubre, Madrid

28100

WITHDRAWN

Azienda Ospedaliero-Universitaria Maggiore della Carità Novara_SC Oncologia Medica, Novara

29010

WITHDRAWN

H.U. Virgen de la Victoria, Málaga

40202

COMPLETED

Norton Cancer Institute, Norton Healthcare Pavilion, Louisville

45409

WITHDRAWN

Precision Cancer Research/Dayton Physicians Network - Treatment, Kettering

47014

WITHDRAWN

IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) UO Oncologia Medica, Meldola (FC)

56126

WITHDRAWN

Azienda Ospedaliero Universitaria Pisana_ UO Oncologia Medica Universitaria, Pisa

68130

WITHDRAWN

GU Research Network/Urology Cancer Center, Omaha

COMPLETED

Nebraska Cancer Specialists, Omaha

70121

COMPLETED

Ochsner Clinic Foundation, New Orleans

75701

COMPLETED

HOPE Cancer Center of East Texas, Tyler

80131

WITHDRAWN

Istituto Nazionale dei Tumori-Fondazione Pascale- SC Oncologia Medica, Napoli

85004

WITHDRAWN

University Of UA Cancer Center(UACC)/DH-SJHMC, Phoenix

94158

WITHDRAWN

UCSF Helen Diller Family Comphrensive Cancer Center - Hemato, San Francisco

95126

WITHDRAWN

A.O. Cannizzaro_UOS Oncologia Medica, Catania

95817

WITHDRAWN

University of California Davis Comprehensive Cancer Center, Sacramento

97239

COMPLETED

Oregon Health and Science University, Portland

99208

WITHDRAWN

Medical Oncology Associates, PS (dba Summit Cancer Centers), Spokane

100142

RECRUITING

Beijing Cancer Hospital, Beijing

200032

NOT_YET_RECRUITING

Zhongshan Hospital Affiliated to Fudan University, Shanghai

'00168

WITHDRAWN

Fondazione Policlinico Universitario A. Gemelli, U.O.C. Oncologia Medica, Roma

36-200

WITHDRAWN

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny, Brzozów

81-519

WITHDRAWN

Szpitale Pomorskie Sp. z o.o. Oddział Onkologii i Radioterapii, Gdynia

31-826

COMPLETED

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. Oddział Onkologii Klinicznej z Pododdziałem Dziennym, Krakow

60-848

WITHDRAWN

Clinical Research Center Sp. z o.o., Medic-R Sp. K., Poznan

03722

COMPLETED

Severance Hospital, Yonsei University Health System - Medical Oncology, Seoul

05505

COMPLETED

Asan Medical Center - University of Ulsan College of Medicin, Seoul

06351

WITHDRAWN

Samsung Medical Center - Hematology-Oncology, Seoul

03203

WITHDRAWN

H.G.U. de Elche, Elche

All Listed Sponsors
lead

Xynomic Pharmaceuticals, Inc.

INDUSTRY