Status:
TERMINATED
A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC)
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Prostatic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 pre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05295927
Start Date
March 23 2022
End Date
September 30 2022
Last Update
February 3 2025
Active Locations (4)
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1
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
2
GU Research Network
Omaha, Nebraska, United States, 68130
3
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
4
Prostate Cancer Centre
Calgary, Alberta, Canada, T2V 1P9