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. 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