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

NCT03436485 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 3124001
• Study Type: interventional
• Target: 204
• Locations: 4 countries
• Sites: 20

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.

Conditions

Prostate Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD)

  Highest dose level at which under 33% of patients in a cohort experience DLT

  Within first 28 days of treatment

Study Arms (3)

ODM-208 Part 1 Dose escalation

EXPERIMENTAL

Drug: ODM-208

ODM-208 Part 2 Dose expansion

EXPERIMENTAL

Drug: ODM-208

ODM-208 Part 2 Drug drug interaction

EXPERIMENTAL

Drug: ODM-208; Drug: Midazolam

Interventions

ODM-208 DRUG

co-administered with glucocorticoid and fludrocortisone, orally daily

ODM-208 Part 1 Dose escalation; ODM-208 Part 2 Dose expansion; ODM-208 Part 2 Drug drug interaction

Midazolam DRUG

orally

ODM-208 Part 2 Drug drug interaction

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (20)

University of Maryland Marlene and Stewart Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68114, United States

Location

University at Buffalo, Kaleida Health Great Lakes Cancer Care Collaborative

Buffalo, New York, 14203, United States

Location

Helsinki University Central Hospital

Helsinki, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Institute Bergonié

Bordeaux, France

Location

Centre Léon Bérard

Lyon, France

Location

Institute Paoli-Calmettes

Marseille, France

Location

Institut de cancérologie Strasbourg Europe

Strasbourg, France

Location

Hopital Foch

Suresnes, 92150, France

Location

Institut Gustave Roussy

Villejuif, France

Location

The Rutherford Cancer Centre, North East

Bedlington, United Kingdom

Location

Velindre Cancer Centre

Cardiff, CF14 2TL, United Kingdom

Location

The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

The Rutherford Cancer Centre, North West

Liverpool, United Kingdom

Location

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

Charing Cross Hospital

London, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, United Kingdom

Location

Royal Preston Hospital

Preston, PR2 9HT, United Kingdom

Location

Related Publications (1)

• Fizazi K, Bernard-Tessier A, Roubaud G, Utriainen T, Barthelemy P, Flechon A, van der Voet J, Gravis G, Ratta R, Jones R, Parikh O, Tanner M, Antonarakis ES, Baldini C, Peters N, Garratt C, Ikonen T, Pohjanjousi P, Joensuu H, Cook N. Targeted Inhibition of CYP11A1 in Castration-Resistant Prostate Cancer. NEJM Evid. 2024 Jan;3(1):EVIDoa2300171. doi: 10.1056/EVIDoa2300171. Epub 2023 Dec 26.

  PMID: 38320513 DERIVED

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Karim Fizazi

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 19, 2018
• Study Start: March 19, 2018
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

GB (8); FI (2); US (4); FR (6)