AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 3Ages 18 Years - anyAllXynomic Pharmaceuticals, Inc.
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: To be enrolled in the study, patients will be required to meet all of the following criteria: * Patients aged โ‰ฅ 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 โ‰ฅ 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 โ‰ฅ 160 or diastolic blood pressure โ‰ฅ 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.
๐Ÿ’Š

What it tests

  • Pazopanib
  • Abexinostat
  • Placebo
๐Ÿ“

Where

38 sites
University Of UA Cancer Center(UACC)/DH-SJHMC
Phoenix, United States
University of California Davis Comprehensive Cancer Center
Sacramento, United States
UCSF Helen Diller Family Comphrensive Cancer Center - Hemato
San Francisco, United States
Norton Cancer Institute, Norton Healthcare Pavilion
Louisville, United States
Ochsner Clinic Foundation
New Orleans, United States
GU Research Network/Urology Cancer Center
Omaha, United States
Nebraska Cancer Specialists
Omaha, United States
Northwell Health/Monter Cancer Center
Lake Success, United States

โ€ฆand 30 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy