At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 136 enrolled
Drug / intervention
ODM-201drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Pharmacokinetics of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Multiple Dose Escalation Study With a Randomised Phase II Expansion Component
In Brief
A Phase 2 clinical trial evaluating ODM-201 for Prostate Cancer. Completed, enrolled 136 participants across 23 sites in 6 countries.
Detailed Summary
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesCzechia, Estonia, Finland, France, United Kingdom, United States
CollaboratorsEndo Pharmaceuticals
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
First PostedMar 2011
Primary CompletionJul 2013
TodayJul 2026
First PostedMar 17, 2011
Enrollment StartMar 1, 2011
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.3 years ago
Interventions
ODM-201drug
ODM-201 administered orally daily