Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT03592472

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

Led by Xynomic Pharmaceuticals, Inc. · Updated on 2025-04-13

413

Participants Needed

38

Research Sites

519 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 2018 years or older at study entry
  • Histologically confirmed renal cell carcinoma with clear cell component
  • Locally advanced unresectable or metastatic disease
  • Measurable disease as assessed by the investigator according to RECIST version 1.1
  • No prior treatment with VEGF tyrosine kinase inhibitors
  • Up to one prior line of cytokine or immune checkpoint inhibitor treatment allowed if progressive disease is confirmed
  • ECOG performance status of 0 or 1
  • Adequate baseline organ and hematologic function
  • At least 2 weeks since last systemic treatment or radiation before randomization
Not Eligible

You will not qualify if you...

  • Persistent clinically significant toxicities (Grade 2 2) from previous anticancer therapy (excluding alopecia and certain manageable lab abnormalities)
  • Untreated central nervous system metastases
  • Additional malignancy requiring treatment within the past 3 years, except non-melanoma skin cancer, carcinoma in situ, or non-muscle invasive urothelial carcinoma
  • Poorly controlled hypertension (systolic 2 160 or diastolic 2 100 mmHg)
  • New pulmonary embolism or deep venous thrombosis within 3 months before randomization
  • QTcF interval greater than 480 msec
  • New York Heart Association Class III or IV congestive heart failure
  • Use of prohibited medications within 7 days or 5 half-lives before first study drug dose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 38 locations

1

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

Phoenix, Arizona, United States, 85004

Withdrawn

2

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States, 95817

Withdrawn

3

UCSF Helen Diller Family Comphrensive Cancer Center - Hemato

San Francisco, California, United States, 94158

Withdrawn

4

Norton Cancer Institute, Norton Healthcare Pavilion

Louisville, Kentucky, United States, 40202

Completed

5

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

Completed

6

GU Research Network/Urology Cancer Center

Omaha, Nebraska, United States, 68130

Withdrawn

7

Nebraska Cancer Specialists

Omaha, Nebraska, United States, 68130

Completed

8

Northwell Health/Monter Cancer Center

Lake Success, New York, United States, 11042

Withdrawn

9

Mainstreet Physicans Care

Rochester, New York, United States, 14642

Completed

10

Precision Cancer Research/Dayton Physicians Network - Treatment

Kettering, Ohio, United States, 45409

Withdrawn

11

Oregon Health and Science University

Portland, Oregon, United States, 97239

Completed

12

St. Luke's Hospital

Easton, Pennsylvania, United States, 18045

Completed

13

HOPE Cancer Center of East Texas

Tyler, Texas, United States, 75701

Completed

14

Medical Oncology Associates, PS (dba Summit Cancer Centers)

Spokane, Washington, United States, 99208

Withdrawn

15

Beijing Cancer Hospital

Beijing, China, 100142

Actively Recruiting

16

Zhongshan Hospital Affiliated to Fudan University

Shanghai, China, 200032

Not Yet Recruiting

17

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

Candiolo, Italy, 10060

Withdrawn

18

A.O. Cannizzaro_UOS Oncologia Medica

Catania, Italy, 95126

Withdrawn

19

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

Meldola (FC), Italy, 47014

Withdrawn

20

Istituto Europeo di Oncologia_Unità Oncologia Medica Urogenitale e Cervico Facciale

Milan, Italy, 20141

Withdrawn

21

Istituto Nazionale dei Tumori-Fondazione Pascale- SC Oncologia Medica

Naples, Italy, 80131

Withdrawn

22

Azienda Ospedaliero-Universitaria Maggiore della Carità Novara_SC Oncologia Medica

Novara, Italy, 28100

Withdrawn

23

Istituti Clinici Scientifici Maugeri Spa-SB_ UO Oncologia Medica

Pavia, Italy, 27100

Withdrawn

24

Azienda Ospedaliero Universitaria Pisana_ UO Oncologia Medica Universitaria

Pisa, Italy, 56126

Withdrawn

25

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

Roma, Italy, '00168

Withdrawn

26

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny

Brzozów, Poland, 36-200

Withdrawn

27

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

Gdynia, Poland, 81-519

Withdrawn

28

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

Krakow, Poland, 31-826

Completed

29

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

Poznan, Poland, 60-848

Withdrawn

30

National Cancer Center - Center For Prostate Cancer

Goyang-si, South Korea, 10408

Completed

31

CHA Bundang Medical Center, CHA University

Seongnam-si, South Korea, 13496

Completed

32

Severance Hospital, Yonsei University Health System - Medical Oncology

Seoul, South Korea, 03722

Completed

33

Asan Medical Center - University of Ulsan College of Medicin

Seoul, South Korea, 05505

Completed

34

Samsung Medical Center - Hematology-Oncology

Seoul, South Korea, 06351

Withdrawn

35

H.G.U. de Elche

Elche, Spain, 03203

Withdrawn

36

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain, 28040

Withdrawn

37

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Completed

38

H.U. Virgen de la Victoria

Málaga, Spain, 29010

Withdrawn

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Research Team

S

Sophia Paspal, Ph.D.

CONTACT

R

Rahul Aggarwal, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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