drugset / Trial / NCT01784757
Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
Phase 1
Completed
30 enrolled
Orion Corporation, Orion Pharma
Endo USA Inc., a Keenova Therapeutics Company · collab
RandomizedCrossoverOpen-labelBasic science
Summary
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.
Timeline
- Start
- 2013-03
- Primary completion
- 2013-08
- Completion
- 2020-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darolutamide | Other / unclassified | 1200 mg | Oral |
| Subject | Darolutamide | Other / unclassified | 1400 mg | Oral |
| Subject | Darolutamide | Other / unclassified | 1800 mg | Oral |