Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in patients with metastatic castration-resistant prostate cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orion Corporation, Orion Pharma

Criteria

Main Inclusion Criteria:

• Written informed consent (IC) obtained.

• Male aged ≥ 18 years.

• Histologically confirmed adenocarcinoma of the prostate.

• Castration resistant prostate cancer with serum testosterone < 50 ng/dl.

• Metastatic disease.

• Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy.

• Received at least one prior line of novel hormonal androgen receptor (AR) targeted therapy (e.g. abiraterone, enzalutamide).

• ECOG performance status 0-1.

• Adequate marrow, liver and kidney function.

• Able to swallow study treatment.

• Part 1: Treatment with at least 1 line of chemotherapy or ineligibility for chemotherapy. Part 2: Treatment with at least 1 line of taxane-based chemotherapy in castration-sensitive prostate cancer (CSPC) or in CRPC.

• Part 2: Identified activating mutation in the LBD of AR in plasma ctDNA confirmed by the central testing.

Main Exclusion Criteria:

• History of pituitary or adrenal dysfunction.

• Known brain metastases or active leptomeningeal disease.

• Active infection or other medical condition that would make corticosteroid contraindicated.

• Poorly controlled diabetes.

• Hypotension or uncontrolled hypertension.

• Clinically significantly abnormal serum potassium or sodium level.

• Active or unstable cardio/cerebro-vascular disease including thromboembolic events.

• Prolonged QTcF interval.