Clinical trial · Interventional
Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer
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
NCT01317641CI-TRIAL-00026679completedPhase 1 / Phase 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, tolerability and pharmacokinetics 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 (4)
- type
- EXPERIMENTAL
- label
- ODM-201 Phase I
- interventionNames
- Drug: ODM-201
- type
- EXPERIMENTAL
- label
- ODM-201 Phase II Dose 1
- interventionNames
- Drug: ODM-201
- type
- EXPERIMENTAL
- label
- ODM-201 Phase II Dose 2
- interventionNames
- Drug: ODM-201
- type
- EXPERIMENTAL
- label
- ODM-201 Phase II Dose 3
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Histologically confirmed adenocarcinoma of prostate * Ongoing androgen deprivation therapy with a LHRH analogue or antagonist or bilateral orchiectomy * Progressive metastatic disease * Adequate bone marrow, hepatic, and renal function Exclusion Criteria: * Known metastases in the brain * History of other malignancy within the previous 5 years * Known gastrointestinal disease or procedure that affects the absorption * Not able to swallow the study drug
References
Publications (1)
- 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