Oral EPI-7386 in Patients With Castration-Resistant Prostate Cancer
EPI-7386-CS-001 (primary)
NCI-2020-11720
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 this is the first study of EPI-7386 in humans, there is no information about how it
affects people or what dose should be used. Therefore, the main purpose of this study is to
assess the safety (side effects) of EPI-7386 and to find a dose that can be given without
unacceptable side effects.
There are other important things that will be evaluated during the study:
- How the amount of EPI-7386 in the blood changes over time.
- The effect of EPI-7386 on prostate cancer.
- The effect of EPI-7386 on certain substances in the body.
- The possibility that EPI-7386 can interact with other drugs.
The study will be conducted in 2 parts:
- Part A: To evaluate the safety and tolerability of EPI-7386 as a single agent via 2
Phases:
- Phase 1a: Dose Escalation (mCRPC)
- Phase 1b: Dose Expansion (mCRPC)
- Part B: To evaluate 2 parallel enrolling cohorts (Cohort 1 and Cohort 2) of EPI-7386 in
combination of apalutamide acetate + prednisone (AAP) or apalutamide (APA):
- Cohort 1: Combination with AAP in mHSPC or mCRPC patients
- Cohort 2: Will evaluate the anti-tumor activity of EPI-7386 for a limited window of
time (12 weeks EPI-7386 monotherapy prior to the start of combination therapy with
APA) in nmCRPC patients unperturbed by previous 2nd generation anti-androgen
therapies or chemotheraphy.
Eligibility
- 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) Inclusion Criteria: 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) Inclusion Criteria:
- 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-a 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.
Treatment Sites in Georgia
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