drugset / Trial / NCT03150056

Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy in Participants With Castrate-resistant Prostate Cancer

NCT03150056

Phase 1 Terminated 73 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims to evaluate the combination of GSK525762 with other agents that have been shown to be effective in the treatment of CRPC or metastatic (m)CRPC. This study is designed to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) based on safety, tolerability, pharmacokinetic, and efficacy profiles of GSK525762 in combination with either abiraterone (Arm A) or enzalutamide (Arm B).

Timeline

Start
2017-07-18
Primary completion
2020-07-31
Completion
2021-06-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Abiraterone acetate Small molecule
Subject Enzalutamide Other / unclassified
Subject Molibresib Small molecule
Background Prednisone Other / unclassified

Indications