drugset / Trial / NCT01784757

Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer

NCT01784757

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

EvaluationDrugModalityDoseRoute
Subject Darolutamide Other / unclassified 1200 mg Oral
Subject Darolutamide Other / unclassified 1400 mg Oral
Subject Darolutamide Other / unclassified 1800 mg Oral

Indications