A Phase 1/2 Open-label Study of Orally Administered EPI-506
Research type
Research Study
Full title
A Phase 1/2 Open-label Study to Assess the Safety,Pharmacokinetics, and Anti-tumor Activity of Oral EPI-506 in Patients with Metastatic Castration-resistant Prostate Cancer
IRAS ID
200721
Contact name
Gerhardt Attard
Contact email
Sponsor organisation
Essa Pharmaceutical Corp.
Eudract number
2015-004764-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 3 days
Research summary
This a Phase 1/2, open-label study to assess the safety, tolerability, and anti-tumor activity of oral EPI-506 in patients with metastatic prostate cancer resistant to androgen deprivation therapy and abiraterone and/or enzalutamide and are either not candidates for cytotoxic treatment or have previously received one line of chemotherapy. The study will consist of Part I-Dose Escalation and Part II-Dose Expansion. For Part I, six dose levels of EPI-506 will be studied: 80,160, 240, 320, 400, and 480 mg/day. Patients will be monitored for safety and clinical benefit. The recommended phase 2 dose will be selected after review of all safety and efficacy data from Part I. In Part II, patient populations of abiraterone resistance, enzalutamide resistance, and both abiraterone and enzalutamide resistance will be studied at the recommended phase 2 dose determined in Part I. Patients will continue taking EPI-506 until protocol defined discontinuation criteria are met.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
16/LO/0958
Date of REC Opinion
20 Jul 2016
REC opinion
Further Information Favourable Opinion