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Protocol # 20-435




This is a phase I, clinical research study of EPI-7386, an investigational drug being studied as a treatment for patients with prostate cancer. All patients in the study will receive EPI-7386. Since this is the first study of EPI-7386 in humans, there is no information about how it affects people or what dose should be used. Therefore, the main purpose of this study is to assess the safety (side effects) of EPI-7386 and to find a dose that can be given without unacceptable side effects. There are other important things that will be evaluated during the study: - How the amount of EPI-7386 in the blood changes over time. - The effect of EPI-7386 on prostate cancer. - The effect of EPI-7386 on certain substances in the body. - The possibility that EPI-7386 can interact with other drugs.


  • Prostate Cancer


  • EPI-7386 (QD)
  • EPI-7386 (BID)


Phase 1

Study Type


Further Study Details

Primary Outcome:

  • The primary safety variable for Part 1a of the study is the incidence of protocol-defined DLT during the DLT assessment period (first 28 days of dosing).
  • The primary efficacy variable for Part 1b of the study is the proportion of patients with a decline from baseline in PSA blood concentrations of ≥50% at any time point during daily dosing with EPI-7386.



Study Start Date

June 23, 2020


  • Gender:     Male
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No


ESSA Pharmaceuticals


ESSA Pharmaceuticals

Official title

A Phase 1, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral EPI-7386 in Patients With Metastatic Castration-Resistant Prostate Cancer Identifier



Source: Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.