EPI-7386 with Enzalutamide for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Moffitt Cancer Center, Tampa, FLProstate CancerEPI-7386 with Enzalutamide - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing a new combination drug to see if it is safe and effective in treating prostate cancer that has spread.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Study Objectives

5 Primary · 0 Secondary · Reporting Duration: Baseline to End of Cycle 1 (each cycle is 28 days)

Day 30
Phase 1: Changes in ECOG performance status
Phase 1: Incidence of laboratory abnormalities as a measure of safety and tolerability of EPI-7386
Phase 1: Incidence of treatment emergent adverse events
Day 28
Phase 1: Incidence of Dose Limiting Toxicities
Baseline to Week 12
Phase 2: Proportion of subjects with a prostate-specific antigen decline of >50% (PSA50) at Week 12

Trial Safety

Trial Design

7 Treatment Groups

Phase 2 Enzalutamide single agent
1 of 7
Phase 1 Dose Expansion
1 of 7
Phase 2 Enzalutamide + EPI-7386 (Randomized 2:1)
1 of 7
Phase 1 Cohort 2
1 of 7
Phase 1 Cohort 1
1 of 7
Phase 1 Cohort 4
1 of 7
Phase 1 Cohort 3
1 of 7

Active Control

Experimental Treatment

150 Total Participants · 7 Treatment Groups

Primary Treatment: EPI-7386 with Enzalutamide · No Placebo Group · Phase 1 & 2

Phase 1 Dose Expansion
Drug
Experimental Group · 1 Intervention: EPI-7386 with Enzalutamide · Intervention Types: Drug
Phase 2 Enzalutamide + EPI-7386 (Randomized 2:1)
Drug
Experimental Group · 1 Intervention: EPI-7386 with Enzalutamide · Intervention Types: Drug
Phase 1 Cohort 2
Drug
Experimental Group · 1 Intervention: EPI-7386 with Enzalutamide · Intervention Types: Drug
Phase 1 Cohort 1
Drug
Experimental Group · 1 Intervention: EPI-7386 with Enzalutamide · Intervention Types: Drug
Phase 1 Cohort 4
Drug
Experimental Group · 1 Intervention: EPI-7386 with Enzalutamide · Intervention Types: Drug
Phase 1 Cohort 3
Drug
Experimental Group · 1 Intervention: EPI-7386 with Enzalutamide · Intervention Types: Drug
Phase 2 Enzalutamide single agent
Drug
ActiveComparator Group · 1 Intervention: Enzalutamide · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to end of cycle 1 (each cycle is 28 days)

Who is running the clinical trial?

ESSA PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
102 Total Patients Enrolled
1 Trials studying Prostate Cancer
74 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 11 Total Inclusion Criteria

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Frequently Asked Questions

Are participants being enrolled in this experiment right now?

"That is correct. The clinicaltrials.gov website lists this trial as "recruiting." It was originally posted on December 21st, 2021 and updated June 30th, 2022. They are looking for 150 people to participate at 7 different locations." - Anonymous Online Contributor

Unverified Answer

What is the total number of research facilities conducting this experiment?

"Presently, there are 7 sites that are enrolling patients for this clinical trial with additional locations in Buffalo, Madison and Port Saint Lucie. If you elect to participate in this study, please choose the site closest to your residence to minimize travel." - Anonymous Online Contributor

Unverified Answer

How many people are total are included in this experiment?

"The sponsor, ESSA Pharmaceuticals, needs to recruit 150 participants that meet the eligibility requirements in order to commence this study. The trial will be conducted at various sites - two locations being Roswell Park Comprehensive Cancer Center (Buffalo, New York) and University of Wisconsin (Madison, Wisconsin)." - Anonymous Online Contributor

Unverified Answer

Are there any other similar medical studies that have used EPI-7386 in combination with Enzalutamide?

"103 different clinical trials are being conducted for EPI-7386 with Enzalutamide. 30 of those currently active studies are in Phase 3. Most research concerning EPI-7386 is based out of Germantown, Tennessee; however, 5748 locations worldwide are running these types of trials." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.