RECRUITING

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

Conditions

Renal Cell Carcinoma Progression-free survival Abexinostat Pazopanib RECIST Cancer therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2018-07-17

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03592472

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Sophia Paspal, Ph.D.

CONTACT

6104055974

sophia.paspal@xynomicpharma.com

Rahul Aggarwal, M.D.

CONTACT

rahul.aggarwal@ucsf.edu

Principal Investigator

Pamela Munster, M.D.

STUDY_CHAIR

University of California, San Francisco

Rahul Aggarwal, M.D.

STUDY_CHAIR

University of California, San Francisco

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Xynomic Pharmaceuticals, Inc.

Pamela Munster, M.D., STUDY_CHAIR, University of California, San Francisco
Rahul Aggarwal, M.D., STUDY_CHAIR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-07-17

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2018-07-17

Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

Renal Cell Carcinoma
Progression-free survival
Abexinostat
Pazopanib
RECIST
Cancer therapy

Additional Relevant MeSH Terms

Renal Cell Carcinoma