Safety and Anti-Tumour Study of Oral EPI-506 for Patients With Metastatic Castration-Resistant Prostate Cancer

Official Title

A Phase 1/2 Open-Label Study to Assess the Safety, Pharmacokinetics, and Anti-Tumour Activity of Oral EPI-506 in Patients With Metastatic Castration-Resistant Prostate Cancer

Summary:

The study will consist of 2 parts: Part I (Dose Escalation) and Part II (Dose Expansion). In Part I, patients will participate in single, multiple, and long-term dosing periods using EPI-506 to determine safety, pharmacokinetics, the maximum tolerated dose, and preliminary indications of anti-tumour activity. Part I is an open-label, adaptive 3 + 3 design, dose-escalation study. Approximately six dose levels of EPI-506 will be studied, beginning at 80 mg/day. Enrolled patients may be allowed to escalate to a subsequent dose cohort after their initial twelve weeks. Additional patients may be enrolled at any safe dose level prior to or concurrent with enrolling patients in Part II. In Part II, 3 patient populations; post-abiraterone metastatic castration-resistant prostate cancer (mCRPC) but enzalutamide-naïve, post-enzalutamide mCRPC but abiraterone-naïve, and post-abiraterone and enzalutamide mCRPC will be studied at the recommended Phase 2 dose (RP2D) determined in Part I over 12 weeks of daily dosing. Approximately 120 patients (40 in each cohort) will be enrolled.

Trial Description

Primary Outcome:

• Part I: Safety and tolerability assessed by vital signs, laboratory measurements, and frequency and severity of treatment-related adverse events
• Part II: Prostate-specific antigen (PSA) response rate

• Part I: Define the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)
• Part I: Pharmacokinetics (PK) profile of EPI-506
• Part I: Pharmacokinetics (PK) profile of EPI-002
• Part I: Food effect on PK
• Part I: PSA
• Part II: Safety and tolerability assessed by vital signs, laboratory measurements, and frequency and severity of treatment-related adverse events
• Part II: To evaluate the PK of EPI-506
• Part II: To evaluate the PK of EPI-002
• Part II: Time to PSA progression
• Part II: Radiographic progression
• Part II: Objective response

View this trial on ClinicalTrials.gov