EPI-7386 + Enzalutamide for Prostate Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to study the effects of EPI-7386 in combination with Enzalutamide on participants diagnosed with prostate cancer. The main goals of this study are to evaluate the antitumor activity of EPI-7386 in combination with enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC), and to evaluate the pharmacokinetics (PK) of EPI-7386 when dosed in combination with enzalutamide. Participants will will take the study drug, EPI-7360, twice a day by mouth and enzalutamide once a day by mouth, alongside clinic visits every two weeks.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use certain drugs that affect liver enzymes (CYP3A and CYP2C8) before starting the study. It's best to discuss your current medications with the study team to see if any adjustments are needed.
What data supports the effectiveness of the drug Enzalutamide for prostate cancer?
What safety information is available for the treatment EPI-7386 + Enzalutamide for prostate cancer?
What makes the drug EPI-7386 + Enzalutamide unique for prostate cancer?
The combination of EPI-7386 and Enzalutamide is unique because it targets the androgen receptor signaling pathway, which is crucial in the progression of castration-resistant prostate cancer (CRPC). Enzalutamide is an oral drug that blocks the androgen receptor's interaction with DNA, helping to slow down cancer growth and improve survival rates in patients who have already undergone chemotherapy.12389
Research Team
Pedro Barata, MD, MSc
Principal Investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Christopher Wee, MD
Principal Investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Eligibility Criteria
This trial is for individuals with newly diagnosed metastatic hormone-sensitive prostate cancer. Participants will take EPI-7386 and Enzalutamide orally, alongside standard Androgen Deprivation Therapy. They must be able to attend clinic visits every two weeks.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive EPI-7386 and Enzalutamide orally for 36 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Enzalutamide
- EPI-7386
Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pedro Barata, MD, MSc
Lead Sponsor
ESSA Pharma Inc.
Collaborator