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NCT01317641 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer
A Phase 1 study, sponsored by Orion Corporation, Orion Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 136
- Enrollment target
NCT01317641: Completed Phase 1 study, sponsored by Orion Corporation, Orion Pharma.
NCT01317641 is a Phase 1 study that has completed, run by Orion Corporation, Orion Pharma. The registered enrollment target is 136 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (127% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01317641, a Phase 1 study, has completed, sponsored by Orion Corporation, Orion Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 136 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.
Primary Outcome
A DLT was any Grade 3 or more toxicity (by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE version 4.03\]) excluding less than Grade 4 neutropenia or thrombocytopenia, hematological toxicity lasting less than 7 days, and nausea, vomiting, diarrhea controlled with antiemetic and/or anti-diarrheal treatment.
Interventions
- DRUG ODM-201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-07 |
| Phase | Phase 1 |
What the finished NCT01317641 record still lists
NCT01317641 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (127% higher).
The record links to 0 conditions, and to 1 intervention - of which ODM-201 is the first listed.
NCT01317641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01317641 about?
NCT01317641 is a clinical study titled "Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer". The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.
What is the current status of trial NCT01317641?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 136 participants. The study started on 2011-03. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01317641?
The interventions under investigation include: ODM-201 (DRUG).
Who is sponsoring clinical trial NCT01317641?
This trial is sponsored by Orion Corporation, Orion Pharma, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01317641's enrollment target sits among peer trials
136 422nd of 2000 higher than 1,576 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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