drugset / Trial / NCT03150056
Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy in Participants With Castrate-resistant Prostate Cancer
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
Outcome
Outcome not reported
Stopped: “This study has been terminated due to meeting protocol defined futility.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | — | — |
| Subject | Enzalutamide | Other / unclassified | — | — |
| Subject | Molibresib | Small molecule | — | — |
| Background | Prednisone | Other / unclassified | — | — |