Phase 2
Completed N=76
Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001
Source: ClinicalTrials.gov NCT01429064 ↗Enrolled (actual)
76
Serious AEs
25.0%
Results posted
Dec 2016
Primary outcomePrimary: Number of Participants With Adverse Events — 19; 22; 19; 16 participants
Summary
The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with castrate resistant prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
19; 22; 19; 16 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent
- Successful completion of study protocol 3104001
- Response or stable disease in study 3104001 at week 12
Exclusion Criteria
- New serious concurrent medical condition
- Not able to swallow the study drug
Data sourced from ClinicalTrials.gov (NCT01429064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.