Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer
NCT ID: NCT03436485
Last Updated: 2025-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
204 participants
INTERVENTIONAL
2018-03-19
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ODM-208 Part 1 Dose escalation
ODM-208
co-administered with glucocorticoid and fludrocortisone, orally daily
ODM-208 Part 2 Dose expansion
ODM-208
co-administered with glucocorticoid and fludrocortisone, orally daily
ODM-208 Part 2 Drug drug interaction
ODM-208
co-administered with glucocorticoid and fludrocortisone, orally daily
Midazolam
orally
Interventions
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ODM-208
co-administered with glucocorticoid and fludrocortisone, orally daily
Midazolam
orally
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
MALE
No
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Karim Fizazi
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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University of Maryland Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
University at Buffalo, Kaleida Health Great Lakes Cancer Care Collaborative
Buffalo, New York, United States
Helsinki University Central Hospital
Helsinki, , Finland
Tampere University Hospital
Tampere, , Finland
Institute Bergonié
Bordeaux, , France
Centre Léon Bérard
Lyon, , France
Institute Paoli-Calmettes
Marseille, , France
Institut de cancérologie Strasbourg Europe
Strasbourg, , France
Hopital Foch
Suresnes, , France
Institut Gustave Roussy
Villejuif, , France
The Rutherford Cancer Centre, North East
Bedlington, , United Kingdom
Velindre Cancer Centre
Cardiff, , United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
The Rutherford Cancer Centre, North West
Liverpool, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Countries
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References
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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.
Other Identifiers
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3124001
Identifier Type: -
Identifier Source: org_study_id
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