🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT03592472
Recruiting Phase 3

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

NCT03592472 · tracked via the Priya Life Science China tracker
Sponsor
Xynomic Pharmaceuticals, Inc.
Phase
Phase 3
Started
2018-07-17
Last updated
2025-04-13

Condition(s) studied

Renal Cell Carcinoma

Investigational drug(s) / intervention(s)

PazopanibAbexinostatPlacebo

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (38)

FacilityCityRegionStatus
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

📄 Votrient (pazopanib) drug profile →

More Xynomic Pharmaceuticals, Inc. trials in China

Other trials for the same condition

Official registry record

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 China