A Phase IB Study of GSK525762 plus Abiraterone/Prednisone and/or Enzalutamide to Treat Advanced Prostate Cancer

Full Title

2015N238310: 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)

Purpose

The purpose of this study is to find the highest dose of the new drug GSK525762 that can be given safely with enzalutamide or with abiraterone and prednisone in men with metastatic castration-resistant prostate cancer (advanced cancer which has continued to grow at low testosterone levels). GSK525762 is designed to treat cancer by inhibiting a family of proteins called BET proteins. Lab studies suggest that combining GSK525762 with these drugs may stop cancer cells from growing.

GSK525762 is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic castration-resistant prostate cancer that has continued to grow despite abiraterone/prednisone and/or enzalutamide.
  • Patients must have had the last dose of abiraterone/prednisone and/or enzalutamide within 30 days of entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Wassim Abida at 646-422-4633.

Protocol

17-461

Phase

I

Investigator

Co-Investigators