Kidney Cancer Clinical Trial

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

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).

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Full 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.

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Eligibility Criteria

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.

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

413

Study ID:

NCT03592472

Recruitment Status:

Recruiting

Sponsor:

Xynomic Pharmaceuticals, Inc.

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There are 37 Locations for this study

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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 , 10014, China More Info
Bixia Tang, MD, PhD
Contact
13810211044
[email protected]
Zhongshan Hospital Affiliated to Fudan University
Shanghai , 20003, China More Info
Xiaoyi Hu, MD, PhD
Contact
13917166233
[email protected]
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
Milano , 20141, Italy
Istituto Nazionale dei Tumori-Fondazione Pascale- SC Oncologia Medica
Napoli , 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 , '0016, Italy
National Cancer Center - Center For Prostate Cancer
Goyang-si , 10408, Korea, Republic of
CHA Bundang Medical Center, CHA University
Seongnam-si , 13496, Korea, Republic of
Severance Hospital, Yonsei University Health System - Medical Oncology
Seoul , 03722, Korea, Republic of
Asan Medical Center - University of Ulsan College of Medicin
Seoul , 05505, Korea, Republic of
Samsung Medical Center - Hematology-Oncology
Seoul , 06351, Korea, Republic of
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny
Brzozow , 36-20, Poland
Szpitale Pomorskie Sp. z o.o. Oddział Onkologii i Radioterapii
Gdynia , 81-51, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. Oddział Onkologii Klinicznej z Pododdziałem Dziennym
Krakow , 31-82, Poland
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
Poznan , 60-84, Poland
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

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

413

Study ID:

NCT03592472

Recruitment Status:

Recruiting

Sponsor:


Xynomic Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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