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Androgen Receptor Antagonist
EPI-7386 + Enzalutamide for Prostate Cancer
Phase 1 & 2
Recruiting
Research Sponsored by ESSA Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evidence of castration-resistant prostate cancer (CRPC)
Males ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of cycle 1 (each cycle is 28 days)
Awards & highlights
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.
Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread, who haven't used second-generation anti-androgens or certain other treatments recently. They must have good performance status (able to carry out daily activities) and organ function, with low testosterone levels maintained by ongoing treatment.Check my eligibility
What is being tested?
The trial is testing a new drug combo for advanced prostate cancer. Phase 1 checks the safety of EPI-7386 with enzalutamide at different doses. Phase 2 compares two groups: one taking both drugs and another taking only enzalutamide, based on earlier results for effectiveness without worsening disease.See study design
What are the potential side effects?
Possible side effects include typical reactions from cancer medications such as fatigue, digestive issues, skin reactions, potential blood disorders, hormonal changes affecting mood or energy levels, and possibly seizures due to the nature of these drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is not responding to hormone therapy.
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I am a man aged 18 or older.
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I am fully active or can carry out light work.
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I have not taken second generation anti-androgens.
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My cancer has spread to my bones or other parts of my body, confirmed by scans.
Select...
My prostate cancer has been confirmed by a lab test.
Select...
I am on hormone therapy for cancer or have had surgery to remove my testicles.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to end of cycle 1 (each cycle is 28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of cycle 1 (each cycle is 28 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Changes in ECOG performance status
Phase 1: Incidence of Dose Limiting Toxicities
Phase 1: Incidence of laboratory abnormalities as a measure of safety and tolerability of EPI-7386
+2 moreTrial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2 Enzalutamide + EPI-7386 (Randomized 2:1)Experimental Treatment1 Intervention
RP2D mg EPI-7386 in combination of Enzalutamide RP2D mg
Group II: Phase 1 Cohort 4Experimental Treatment1 Intervention
RP2D mg EPI-7386 in combination of Enzalutamide160 mg
Group III: Phase 1 Cohort 3Experimental Treatment1 Intervention
600 mg BID EPI-7386 in combination of Enzalutamide120 mg
Group IV: Phase 1 Cohort 2Experimental Treatment1 Intervention
800 mg QD EPI-7386 in combination of Enzalutamide120 mg
Group V: Phase 1 Cohort 1Experimental Treatment1 Intervention
600 mg QD EPI-7386 in combination of Enzalutamide120 mg
Group VI: Phase 2 Enzalutamide single agentActive Control1 Intervention
Enzalutamide 160 mg
Find a Location
Who is running the clinical trial?
ESSA PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
127 Total Patients Enrolled
1 Trials studying Prostate Cancer
99 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious heart condition.I am not taking medication that is sensitive to certain liver enzymes.My prostate cancer is not responding to hormone therapy.I have spinal cord compression.I am a man aged 18 or older.I cannot be treated with enzalutamide.I have a rare hereditary fructose intolerance.I haven't had a serious cancer diagnosis in the last 3 years, except for certain skin cancers or superficial bladder cancer.I am fully active or can carry out light work.I have not taken second generation anti-androgens.My cancer has spread to my bones or other parts of my body, confirmed by scans.My prostate cancer has been confirmed by a lab test.I received a blood transfusion within the last 28 days.I have been on a stable dose of bone-targeting therapy for at least 28 days.My brain metastasis has been treated and stable for at least 28 days.I haven't had biologic cancer therapy in the last 28 days.I am on hormone therapy for cancer or have had surgery to remove my testicles.I am not taking medications that strongly affect liver enzyme CYP2C8.I am allergic to ingredients in EPI-7386 or enzalutamide.I am not taking medication that strongly affects liver enzymes.I haven't used hormonal agents for prostate cancer in the last 28 days.I had targeted bone radiotherapy or any radiotherapy within the last 2 weeks.I haven't used radium-223 or similar treatments in the last 28 days.I haven't used herbal products or alternative therapies that might affect PSA levels or act against prostate cancer in the last 28 days.I have stomach or intestine problems that affect how my body absorbs medicine.I do not have any other major health issues.My organs are functioning well.I haven't used any immune system boosters in the last week.I have a history of seizures or conditions that could lead to seizures.I haven't taken any cancer drugs or been in a trial for 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 Enzalutamide + EPI-7386 (Randomized 2:1)
- Group 2: Phase 2 Enzalutamide single agent
- Group 3: Phase 1 Cohort 2
- Group 4: Phase 1 Cohort 1
- Group 5: Phase 1 Cohort 4
- Group 6: Phase 1 Cohort 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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)."
Answered by AI
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."
Answered by AI
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