Status:
TERMINATED
Oral EPI-7386 in Patients with Castration-Resistant Prostate Cancer
Lead Sponsor:
ESSA Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
This is a phase I, clinical research study of EPI-7386, an investigational drug being studied as a treatment for patients with prostate cancer. All patients in the study will receive EPI-7386. Since ...
Eligibility Criteria
Inclusion
- Part A/Phase 1a (Dose Escalation)
- Male 18 years of age or older.
- Histologically, pathologically, or cytologically confirmed prostate cancer without small cell features.
- Evidence of castration-resistant prostate cancer (CRPC).
- Presence of metastatic disease at study entry documented by 1 or more bone lesions on bone scan or by soft tissue disease observed by CT/MRI.
- Limited further treatment options available known to confer clinical benefit in this disease setting from the perspective of the treating physician. Specifically, patients must have progressed on at least 2, but not more than 3, prior approved systemic therapies for mCRPC which include at least one, but not more than 2, second generation anti-androgen drug.
- Patients may have received prior docetaxel for mCSPC or mCRPC but must not have had disease progression during, or within 6 months of completing chemotherapy. Only one line of prior chemotherapy is allowed.
- Evidence of progressive disease defined as 1 or more Prostate Cancer Working Group 3 (PCWG3) criteria.
- The patient must have recovered from toxicities related to any prior treatments.
- Castrate at screening.
- Patients receiving bisphosphonates or other approved bone-targeting therapy must be on a stable dose for at least 4 weeks prior to the start of study drug.
- Demonstrate adequate organ function.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Part A/Phase 1b (Dose Expansion)
- The inclusion criteria for this cohort are the same as for Phase 1a with the exception of: limit of prior therapies to 2 and prior chemotherapy is not allowed for this cohort of patients.
- Part B/Cohort 1 (EPI-7386 in combination with AAP)
- Patients are eligible to enroll in this cohort if they meet the clinical criteria for receiving AAP as standard of care treatment as per label (i.e., high-risk mHSPC or mCRPC).
- All other inclusion criteria listed for Part A/Phase 1a apply except for those that do not apply to mHSPC or mCRPC patients (i.e. evidence of CRPC and limited treatment options for mCRPC).
- Part B/Cohort 2 (Window of Opportunity with clinical endpoints followed by combination with Apalutamide)
- Male 18 years of age or older.
- Histologically, pathologically, or cytologically confirmed prostate cancer without small cell features.
- Evidence of castration-resistant prostate cancer (CRPC).
- Patients who received a first generation anti-androgen as part of an initial combined androgen blockade therapy or as second-line hormonal therapy must show continuing disease (PSA) progression off the anti-androgen for at least 4 weeks prior to enrollment.
- At least 4 weeks must have elapsed from the use of 5-α reductase inhibitors, estrogens, and any other anti-cancer therapy prior to enrollment.
- At least 4 weeks must have elapsed from major surgery or radiation therapy prior to enrollment.
- The patient must have recovered from toxicities related to any prior treatments.
- Castrate at screening.
- Demonstrate adequate organ function.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Part A Phase 1a and Phase 1b
Exclusion
- Biologic anti-cancer therapy or a cytotoxic chemotherapy within 4 weeks prior to the start of study drug.
- Use of hormonal agents with anti-tumor activity against prostate cancer within 4 weeks prior to the start of study drug.
- Any lutamides or abiraterone within 14 days or 5 half-lives, whichever is longer prior to start of study drug.
- Use of radium-223 dichloride or other radioligand/radiopharmaceutical within 28 days prior to the start of study drug.
- Received limited-field palliative bone radiotherapy \>5 fractions and/or any radiotherapy within 2 weeks prior to the start of study drug.
- Received a blood transfusion within 28 days of screening.
- Received prior chemotherapy (for Part 1b Cohort A only).
- Known intra-cerebral disease or brain metastasis unless adequately treated and stable for the last 4 weeks before enrollment.
- Spinal cord compression.
- Diagnosis of another invasive malignancy within the previous 3 years other than curatively treated non-melanomatous skin cancer or superficial urothelial carcinoma.
- Gastrointestinal disorder affecting absorption.
- Significant cardiovascular disease.
- Concurrent disease or any clinically significant abnormality.
- Use of strong inducers of CYP3A within 14 days of the first dose of study drug.
- Part A Phase 1b (Dose Expansion)
Key Trial Info
Start Date :
June 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2024
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04421222
Start Date
June 23 2020
End Date
December 3 2024
Last Update
February 28 2025
Active Locations (9)
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1
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States, 34952
2
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
4
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110