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

ESSA Pharma

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Genital Neoplasms, Male; Prostatic Neoplasms; Prostatic Diseases; Genital Diseases, Male

Treatments: Drug: EPI-506

Study type: Interventional

Funder types: Industry

Identifiers

NCT02606123

EPI-506-CS-0001

Details and patient eligibility

About

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-tumor 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.

Enrollment: 28 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adenocarcinoma of the Prostate
• Metastatic Disease with at least one lesion on bone scan and/or soft tissue on CT/MRI
• Demonstrated progression on abiraterone and/or enzalutamide
• Demonstrated PSA progression within 12 weeks of study participation
• Castrate testosterone levels at screening with continued Luteinizing hormone-releasing hormone (LHRH) therapy
• Eastern Cooperative Oncology Group (ECOG) score between 0-1
• Asymptomatic or mildly symptomatic

Exclusion criteria

• Candidates for cytotoxic chemotherapy
• Received more than one line of chemotherapy
• Received more than one treatment course of enzalutamide or abiraterone
• Inadequate washout of prohibited hormonally active agents or other prior treatments for prostate cancer (PCa)
• Known intra-cerebral disease or brain mets
• Spinal cord compression within 6 months
• Prior treatment with investigative androgen receptor (AR) agents

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

EPI-506

Experimental group

Description:

Part I: Ascending doses of EPI-506 administered orally to define the maximum tolerated dose.

Treatment:

Drug: EPI-506