Clinical trial · Interventional
Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
A Bioavailability Study of ODM-201 Formulations With a Safety and Tolerability Extension Component in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
- 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)
A study to investigate which of two different tablet formulations of ODM-201 is best suited for use in the further development of the compound in the treatment of metastatic chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing the bioavailability study will be able to receive further treatment with the current capsule formulation of ODM-201 until progression of their disease with the safety and tolerability of ODM-201 being assessed throughout.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ODM-201 capsule formulation | Drug | — | UNRESOLVED |
| ODM-201 Tablet A | Drug | — | UNRESOLVED |
| ODM-201 Tablet B | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ODM-201 Tablet A
- description
- ODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
- interventionNames
- Drug: ODM-201 Tablet A
- Drug: ODM-201 capsule formulation
- type
- EXPERIMENTAL
- label
- ODM-201 Tablet B
- description
- ODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
- interventionNames
- Drug: ODM-201 Tablet B
- Drug: ODM-201 capsule formulation
Primary outcomes (2)
- measure
- Area under the curve (AUC) of ODM-201
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent (IC) obtained. * Histologically confirmed adenocarcinoma of prostate * Progressive metastatic disease * Ongoing androgen deprivation therapy with a luteinising hormone-releasing hormone (LHRH) analogue or antagonist or bilateral orchiectomy * Adequate bone marrow, hepatic and renal function * Able to swallow the ODM-201 whole as a capsule or tablet. Exclusion Criteria: * Previous chemotherapy for prostate cancer. * Known metastases in the brain. * History of other malignancy within the previous 5 years, except a basal cell carcinoma of skin. * Known gastrointestinal condition that can significantly affect the absorption of the study treatment.
References
Publications (1)
- 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