Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer
- Conditions
- Prostate Cancer Metastatic
- Interventions
- Registration Number
- NCT03436485
- Lead Sponsor
- Orion Corporation, Orion Pharma
- 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
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 204
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Trial Locations
- 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