Clinical trial · Interventional
Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001
Safety and Tolerability of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Extension Study to Study 3104001
NCT01429064CI-TRIAL-00026050completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with castrate resistant prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ODM-201 | Drug | Darolutamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ODM-201
- interventionNames
- Drug: ODM-201
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events
- timeFrame
- From first dose of study treatment up to 4 weeks after last dose of study treatment
- description
- Adverse events from start of ODM-201 treatment (in ARADES 3104001 study) until end of study visit (in ARADES-EXT 3104002 study). Median duration on study treatment was 11,0 months.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDShore ND, Tammela TL, Massard C, Bono P, Aspegren J, Mustonen M, Fizazi K. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naive and CYP17 Inhibitor-naive Patients: Follow-up from the ARADES and ARAFOR Trials. Eur Urol Focus. 2018 Jul;4(4):547-553. doi: 10.1016/j.euf.2017.01.015. Epub 2017 Feb 14. PMID 28753851
- DERIVEDFizazi K, Massard C, Bono P, Kataja V, James N, Tammela TL, Joensuu H, Aspegren J, Mustonen M. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Castration-resistant, CYP17 Inhibitor-naive Prostate Cancer: Results from Extended Follow-up of the ARADES Trial. Eur Urol Focus. 2017 Dec;3(6):606-614. doi: 10.1016/j.euf.2017.01.010. Epub 2017 Feb 27. PMID 28753849
- DERIVEDFizazi K, Massard C, Bono P, Jones R, Kataja V, James N, Garcia JA, Protheroe A, Tammela TL, Elliott T, Mattila L, Aspegren J, Vuorela A, Langmuir P, Mustonen M; ARADES study group. Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial. Lancet Oncol. 2014 Aug;15(9):975-85. doi: 10.1016/S1470-2045(14)70240-2. Epub 2014 Jun 25. PMID 24974051