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NCT03592472PHASE3Recruiting

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

Xynomic Pharmaceuticals, Inc.

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

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.

Interventions

DRUG

Pazopanib

DRUG

Abexinostat

OTHER

Placebo

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Conditions

Renal Cell Carcinoma

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