A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-23

Study Completion Date

2022-09-30

Brief Summary

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The purpose of this study is to determine safety, including dose limiting toxicities, and the recommended phase 2 dose (RP2D) of EPI-7386 in separate combinations with (a) abiraterone acetate plus prednisone or prednisolone (AAP) and (b) apalutamide (dose-finding) and to determine the antitumor activity of EPI-7386 in separate combinations with (a) AAP and (b) apalutamide (dose-expansion).

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Detailed Description

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Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: EPI-7386 + Abiraterone Acetate Plus Prednisone (AAP)

Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive EPI-7386 + AAP to determine the recommended phase 2 dose (RP2D) dose of EPI-7386 in combination with AAP in dose finding portion of the study. In dose expansion portion of the study, participants will receive EPI-7386 RP2D in combination with AAP.

Group Type EXPERIMENTAL

EPI-7386

Intervention Type DRUG

EPI-7386 will be administered orally once daily.

Abiraterone Acetate

Intervention Type DRUG

Abiraterone Acetate will be administered orally once daily.

Prednisone or Prednisolone

Intervention Type DRUG

Prednisone or Prednisolone will be administered orally twice daily.

Group B: EPI-3786 + Apalutamide

Participants with mCRPC will receive EPI-7386 + apalutamide to determine RP2D dose of EPI-7386 in combination with apalutamide in dose finding portion of the study. In dose expansion portion of the study, participants will receive EPI-7386 RP2D in combination with apalutamide.

Group Type EXPERIMENTAL

EPI-7386

Intervention Type DRUG

EPI-7386 will be administered orally once daily.

Apalutamide

Intervention Type DRUG

Apalutamide will be administered orally once daily.

Interventions

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EPI-7386

EPI-7386 will be administered orally once daily.

Intervention Type DRUG

Abiraterone Acetate

Abiraterone Acetate will be administered orally once daily.

Intervention Type DRUG

Prednisone or Prednisolone

Prednisone or Prednisolone will be administered orally twice daily.

Intervention Type DRUG

Apalutamide

Apalutamide will be administered orally once daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed prostate adenocarcinoma
* Must be able to continue Gonadotropin-releasing hormone agonist (GnRHa) during the study if not surgically castrate
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1, or 2
* Must be able to swallow oral medicines
* Contraceptive use by men (and female partners of men enrolled in the study who are of childbearing potential or are pregnant) (birth control) use should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
* Willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria

* Known central nervous system (CNS) metastases
* Non-metastatic castration-resistant prostate cancer (CRPC) (biochemical or locoregional disease only) is excluded from trial participation
* Evidence of predominant neuroendocrine/small cell carcinoma features in archival or baseline tumor biopsy specimen(s)
* Symptomatic or impending spinal cord compression, except if participant has received definitive treatment and demonstrates evidence of clinically stable disease
* Known disorder affecting gastrointestinal absorption

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No