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NCT03436485 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer
A Phase 1 study of Prostate Cancer Metastatic, sponsored by Orion Corporation, Orion Pharma.
- Active
- Registry status
- Phase 1
- Development phase
- 204
- Enrollment target
- 20
- Study locations
NCT03436485: Active Phase 1 study of Prostate Cancer Metastatic, sponsored by Orion Corporation, Orion Pharma.
NCT03436485 is a Phase 1 study of Prostate Cancer Metastatic that is active but no longer recruiting, run by Orion Corporation, Orion Pharma. The registered enrollment target is 204 participants, roughly in line with the 216-participant average among 17 other Prostate Cancer Metastatic trials with a reported enrollment target. The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03436485, a Phase 1 study of Prostate Cancer Metastatic, is active but no longer recruiting, sponsored by Orion Corporation, Orion Pharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 204 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Highest dose level at which under 33% of patients in a cohort experience DLT
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG ODM-208
Study Locations (20)
Other
- Helsinki University Central Hospital - Helsinki
- Tampere University Hospital - Tampere
- Institute Bergonié - Bordeaux
- Centre Léon Bérard - Lyon
- Institute Paoli-Calmettes - Marseille
- Institut de cancérologie Strasbourg Europe - Strasbourg
- Hopital Foch - Suresnes
- Institut Gustave Roussy - Villejuif
- The Rutherford Cancer Centre, North East - Bedlington
- Velindre Cancer Centre - Cardiff
- The Beatson West of Scotland Cancer Centre - Glasgow
- The Rutherford Cancer Centre, North West - Liverpool
- Royal Marsden Hospital - London
- Charing Cross Hospital - London
- The Christie NHS Foundation Trust - Manchester
- Royal Preston Hospital - Preston
Maryland
- University of Maryland Marlene and Stewart Greenebaum Cancer Center - Baltimore
Minnesota
- Masonic Cancer Center, University of Minnesota - Minneapolis
Nebraska
- Nebraska Cancer Specialists - Omaha
New York
- University at Buffalo, Kaleida Health Great Lakes Cancer Care Collaborative - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2018-03-19 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 1 |
What the registry record for NCT03436485 still lists
NCT03436485 is an interventional study that assigns participants to a tested intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 216-participant average among 17 other Prostate Cancer Metastatic trials with a reported enrollment target.
The record links to 1 condition, with Prostate Cancer Metastatic appearing as the primary indexed condition, and to 2 interventions - of which Midazolam is the first listed.
NCT03436485 names 20 study sites across 5 states, led by Other, Maryland, Minnesota.
Frequently Asked Questions
What is clinical trial NCT03436485 about?
NCT03436485 is a clinical study titled "Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer". 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.
What is the current status of trial NCT03436485?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 204 participants. The study started on 2018-03-19. Estimated completion is 2026-07-31.
What conditions does trial NCT03436485 study?
This clinical trial studies the following conditions: Prostate Cancer Metastatic.
What interventions are being tested in trial NCT03436485?
The interventions under investigation include: Midazolam (DRUG), ODM-208 (DRUG).
Who is sponsoring clinical trial NCT03436485?
This trial is sponsored by Orion Corporation, Orion Pharma, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03436485 being conducted?
This trial has 20 study locations across Maryland, Minnesota, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer Metastatic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03436485's enrollment target sits among peer trials
204 3rd of 17 higher than 15 of 17 other Prostate Cancer Metastatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer Metastatic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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