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Protocol # 20-435

Status

Recruiting

Description

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. The study will be conducted in 2 parts: - Part 1a: To evaluate the safety and tolerability of EPI-7386 - Part 1b: To evaluate 2 cohorts (Cohort A and Cohort B) enrolling in parallel - Part 1b Cohort A: Will further evaluate the safety and tolerability of EPI-7386 in a patient population that has not been previously treated with chemotherapy. - Part 1b Cohort B: Will evaluate the anti-tumor activity of EPI-7386 for a limited window of time (up to 12 weeks prior to the start of standard of care therapy) in nmCRPC patients unperturbed by previous 2nd generation anti-androgen therapies or chemotheraphy.

Condition

  • Prostate Cancer

Interventions

  • EPI-7386 (QD)
  • EPI-7386 (BID)

Phase

Phase 1

Study Type

Interventional

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 Cohort A is the proportion of patients with a decline from baseline in PSA blood concentrations of ≥50% and ≥90% at any time point during daily dosing with EPI-7386.
  • The primary efficacy variable for Part 1b Cohort B is the proportion of patients with a decline from baseline in PSA blood concentrations of ≥50% and ≥90% at any time point during daily dosing with EPI-7386 up to Week 12.

Enrollment

74

Study Start Date

June 23, 2020

Eligibility

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

Sponsors

ESSA Pharmaceuticals

Source

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 Castration-Resistant Prostate Cancer

Clinicaltrials.gov Identifier

NCT04421222

     

Source: Clinicaltrials.gov. 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.