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
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.
View this trial on ClinicalTrials.gov
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