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

Phase 1

Active, not recruiting

Brief 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.

Detailed Description: Safety and tolerability profile of ODM-208 will be explored

Recruitment & Eligibility

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.

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.

Arm && Interventions

Group	Intervention	Description
ODM-208 Part 1 Dose escalation	ODM-208	-
ODM-208 Part 2 Dose expansion	ODM-208	-
ODM-208 Part 2 Drug drug interaction	ODM-208	-
ODM-208 Part 2 Drug drug interaction	Midazolam	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD)	Within first 28 days of treatment	Highest dose level at which under 33% of patients in a cohort experience DLT

Secondary Outcome Measures

Name	Time	Method

Locations (20): University of Maryland Marlene and Stewart Greenebaum Cancer Center
🇺🇸
Baltimore, Maryland, United States
Masonic Cancer Center, University of Minnesota
🇺🇸
Minneapolis, Minnesota, United States
Tampere University Hospital
🇫🇮
Tampere, Finland
The Beatson West of Scotland Cancer Centre
🇬🇧
Glasgow, United Kingdom
Royal Marsden Hospital
🇬🇧
London, United Kingdom
Institute Bergonié
🇫🇷
Bordeaux, France
The Rutherford Cancer Centre, North West
🇬🇧
Liverpool, United Kingdom
Centre Léon Bérard
🇫🇷
Lyon, France
Institute Paoli-Calmettes
🇫🇷
Marseille, France
Institut de cancérologie Strasbourg Europe
🇫🇷
Strasbourg, France
Hopital Foch
🇫🇷
Suresnes, France
The Rutherford Cancer Centre, North East
🇬🇧
Bedlington, United Kingdom
Velindre Cancer Centre
🇬🇧
Cardiff, United Kingdom
Nebraska Cancer Specialists
🇺🇸
Omaha, Nebraska, United States
Helsinki University Central Hospital
🇫🇮
Helsinki, Finland
University at Buffalo, Kaleida Health Great Lakes Cancer Care Collaborative
🇺🇸
Buffalo, New York, United States
Royal Preston Hospital
🇬🇧
Preston, United Kingdom
The Christie NHS Foundation Trust
🇬🇧
Manchester, United Kingdom
Institut Gustave Roussy
🇫🇷
Villejuif, France
Charing Cross Hospital
🇬🇧
London, United Kingdom