NCT03150056

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

A Phase IB Open-label, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK525762 in Combination With Androgen Deprivation Therapy and Other Agents in Subjects With Castrate-resistant Prostate Cancer (CRPC)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Solid Tumours

Interventions

Type	Name	Description
DRUG	GSK525762	GSK525762 will be administered.
DRUG	Abiraterone	Abiraterone will be administered.
DRUG	Enzalutamide	Enzalutamide will be administered.
DRUG	Prednisone	Prednisone will be administered as a concomitant medication in combination with abiraterone

Timeline

• Start date: 2017-07-18
• Primary completion: 2020-07-31
• Completion: 2021-06-22
• First posted: 2017-05-11
• Last updated: 2022-08-10
• Results posted: 2021-08-26

Locations

20 sites across 4 countries: United States, Australia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study