Phase 3 Study of Pazopanib With or Without Abexinostat for Advanced or Metastatic Renal Cell Carcinoma

What this Trial Is About

Researchers are evaluating the combination of pazopanib with or without abexinostat in patients who have locally advanced unresectable or metastatic renal cell carcinoma RCC. This Phase 3, randomized, double-blind, placebo-controlled study aims to compare the effects of pazopanib plus abexinostat versus pazopanib plus placebo. The study focuses on progression-free survival and other outcomes to understand the potential benefits and risks of adding abexinostat to pazopanib treatment for this condition. Participants will be randomly assigned in a 21 ratio to receive either pazopanib plus abexinostat or pazopanib plus a placebo. Pazopanib is taken daily by mouth throughout each 28-day treatment cycle, while abexinostat or its matching placebo is taken twice daily on specific days within each cycle. If disease progression occurs, patients initially receiving placebo may switch to the combination of pazopanib plus abexinostat. Treatment continues until disease progression, unacceptable side effects, withdrawal, or study closure. Participants will undergo screening within 28 days before starting treatment to confirm eligibility. They will be monitored regularly during treatment cycles with assessments including imaging scans and evaluations of side effects using standard criteria. Outcome measures include progression-free survival, overall survival, response rates, duration of response, and changes in quality of life scores. Follow-up will continue for up to approximately four years, with ongoing safety and efficacy evaluations throughout the study period.

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