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EPI-7386 + Enzalutamide for Prostate Cancer

Phase 2

Waitlist Available

Led By Christopher Wee, MD

Research Sponsored by Pedro Barata, MD, MSc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 weeks, 11 weeks, and 20 weeks after beginning treatment

Awards & highlights

Study Summary

"This trial aims to see how well EPI-7386 works with Enzalutamide in patients with prostate cancer. They want to see if this combination can shrink the tumors and how the body

Who is the study for?

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.Check my eligibility

What is being tested?

The study tests the effectiveness of a new drug combination: EPI-7386 with Enzalutamide, in addition to standard Androgen Deprivation Therapy, against prostate cancer. It aims to assess tumor response and understand how the body processes these drugs.See study design

What are the potential side effects?

Possible side effects include fatigue, hot flashes, reduced sexual desire or activity, nausea, diarrhea or constipation, joint or muscle pain, swelling in arms or legs due to fluid retention.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 weeks, 11 weeks, and 20 weeks after beginning treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 weeks, 11 weeks, and 20 weeks after beginning treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, 11 weeks, and 20 weeks after beginning treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Biochemical response rate

ORR (confirmed)

PSA progesterone-free survival (PFS)

+1 more

Secondary outcome measures

AUC0-24

Changes in Eastern Cooperative Oncology Group (ECOG) performance status

Clearance after extravascular administration

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: EPI-7386 + EnzalutamideExperimental Treatment3 Interventions

EPI-7386 at 600 mg twice daily orally with standard of care Enzalutamide at 160 mg, once daily, orally for 36 months of treatment (11 cycles).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~2760

Androgen Deprivation Therapy (ADT)

2005

Completed Phase 3

~530

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Pedro Barata, MD, MScLead Sponsor

ESSA Pharma Inc.UNKNOWN

Christopher Wee, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there ongoing efforts to enlist individuals for participation in this current research study?

"According to clinicaltrials.gov, this particular investigation is not actively seeking volunteers. The trial's posting date was 8/1/2024 and the last modification occurred on 3/8/2024. While recruitment for this study has ceased, there are currently 2338 other trials in need of participants."

Answered by AI

Has the combination of EPI-7386 and Enzalutamide received approval from the FDA?

"Based on our evaluation at Power, the safety rating for EPI-7386 + Enzalutamide is a 2 as per Phase 2 trial standards. While there is data indicating some level of safety, no evidence supporting efficacy has been documented yet."

Answered by AI

What are the main goals and purposes of this clinical investigation?

"The primary objective of this investigation, assessed during a Post-intervention at Week 4 assessment period, is to determine the Biochemical response rate. Secondary endpoints include evaluating the Rate of abnormalities in clinical laboratory parameters—defined as any deviations from normal values which will be documented based on type, frequency, severity, timing, seriousness and their relationship to the study intervention; Volume of distribution following extravascular drug administration represented by Vss/F; and AUC0-24 referring to the area under the plasma concentration-time curve up to 24 hours after dosing."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer

Pedro Barata, MD, MSc 2024. "Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06312670.