A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC)

Official Title

A Phase 1b Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone or Apalutamide in mCRPC (ARES: Androgen Receptor Eradication Study)

Summary:

The purpose of this study is to determine safety, including dose limiting toxicities, and the recommended phase 2 dose (RP2D) of EPI-7386 in separate combinations with (a) abiraterone acetate plus prednisone or prednisolone (AAP) and (b) apalutamide (dose-finding) and to determine the antitumour activity of EPI-7386 in separate combinations with (a) AAP and (b) apalutamide (dose-expansion).

Trial Description

Primary Outcome:

  • Number of Participants with Adverse Events (AEs)
  • Number of Participants with AEs by Severity
  • Number of Participants with Dose-limiting Toxicities (DLT)
  • Composite Response Rate
Secondary Outcome:
  • Maximum Observed Serum Concentration (Cmax) of EPI-7386 and Abiraterone
  • Time to Reach Maximum Observed Serum Concentration (Tmax) of EPI-7386 and Abiraterone
  • Area Under the Curve From Time Zero to tau (AUC[0-tau]) of EPI-7386 and Abiraterone
  • Minimum Observed Serum Concentration (Cmin) of EPI-7386 and Abiraterone
  • Observed Accumulation Index Based on Cmax (ARCmax) of EPI-7386 and Abiraterone
  • Accumulation Ratio for AUCtau (AR AUCtau) of EPI-7386 and Abiraterone
  • Maximum Observed Serum Concentration (Cmax) of EPI-7386 and Apalutamide
  • Time to Reach Maximum Observed Serum Concentration (Tmax) of EPI-7386 and apalutamide
  • Area Under the Curve From Time Zero to tau (AUC[0-tau]) of EPI-7386 and Apalutamide
  • Minimum Observed Serum Concentration (Cmin) of EPI-7386 and Apalutamide
  • Observed Accumulation Index Based on Cmax (ARCmax) of EPI-7386 and Apalutamide
  • Accumulation Ratio for AUCtau (AR AUCtau) of EPI-7386 and Apalutamide
  • Serum Prostate-Specific Antigen (PSA)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society