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RECRUITING

NCT03592472

PHASE3

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

Sponsor: Xynomic Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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).

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

413

Start Date

2018-07-17

Completion Date

2028-06-30

Last Updated

2025-04-13

Healthy Volunteers

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.

Inclusion Criteria: 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. Exclusion Criteria: Patients who meet any of the following criteria at Screening will not be enrolled in the study: * Has persistent clinically significant toxicities (Grade ≥ 2; per NCI CTCAE version 5 from previous anticancer therapy (excluding alopecia which is permitted and excluding Grades 2 and 3 laboratory abnormalities if they are not associated with symptoms, are not considered clinically significant by the investigator, and can be managed with available medical therapies). * Has untreated central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided imaging demonstrates no new or progressive metastases obtained at least 4 weeks following completion of treatment. CNS imaging during Screening is not required unless clinically indicated. * Has an additional malignancy requiring treatment within the past 3 years. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ, and non-muscle invasive urothelial carcinoma. * Poorly controlled hypertension, defined as systolic blood pressure ≥ 160 or diastolic blood pressure ≥ 100 mmHg. Use of anti-hypertensives and rescreening is permitted. * A new pulmonary embolism or deep venous thrombosis diagnosed within 3 months prior to randomization. * Has a QTcF interval \> 480 msec. * New York Heart Association Class III or IV congestive heart failure. * Use of prohibited medication within 7 days or 5 half-lives, whichever is shorter, prior to first dose of study drug.

Locations (38)

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

Phoenix, Arizona, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

UCSF Helen Diller Family Comphrensive Cancer Center - Hemato

San Francisco, California, United States

Norton Cancer Institute, Norton Healthcare Pavilion

Louisville, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

GU Research Network/Urology Cancer Center

Omaha, Nebraska, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Northwell Health/Monter Cancer Center

Lake Success, New York, United States

Mainstreet Physicans Care

Rochester, New York, United States

Precision Cancer Research/Dayton Physicians Network - Treatment

Kettering, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

St. Luke's Hospital

Easton, Pennsylvania, United States

HOPE Cancer Center of East Texas

Tyler, Texas, United States

Medical Oncology Associates, PS (dba Summit Cancer Centers)

Spokane, Washington, United States

Beijing Cancer Hospital

Beijing, China

Zhongshan Hospital Affiliated to Fudan University

Shanghai, China

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

Candiolo, Italy

A.O. Cannizzaro_UOS Oncologia Medica

Catania, Italy

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

Meldola (FC), Italy

Istituto Europeo di Oncologia_Unità Oncologia Medica Urogenitale e Cervico Facciale

Milan, Italy

Istituto Nazionale dei Tumori-Fondazione Pascale- SC Oncologia Medica

Naples, Italy

Azienda Ospedaliero-Universitaria Maggiore della Carità Novara_SC Oncologia Medica

Novara, Italy

Istituti Clinici Scientifici Maugeri Spa-SB_ UO Oncologia Medica

Pavia, Italy

Azienda Ospedaliero Universitaria Pisana_ UO Oncologia Medica Universitaria

Pisa, Italy

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

Roma, Italy

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny

Brzozów, Poland

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

Gdynia, Poland

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

Krakow, Poland

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

Poznan, Poland

National Cancer Center - Center For Prostate Cancer

Goyang-si, South Korea

CHA Bundang Medical Center, CHA University

Seongnam-si, South Korea

Severance Hospital, Yonsei University Health System - Medical Oncology

Seoul, South Korea

Asan Medical Center - University of Ulsan College of Medicin

Seoul, South Korea

Samsung Medical Center - Hematology-Oncology

Seoul, South Korea

H.G.U. de Elche

Elche, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

H.U. Virgen de la Victoria

Málaga, Spain

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (38)