drugset

drugset / Trial / NCT01317641

Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer

NCT01317641 ↗

Phase 1/2 Completed 136 enrolled Orion Corporation, Orion Pharma Endo USA Inc., a Keenova Therapeutics Company · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.

Timeline

Start: 2011-03
Primary completion: 2013-07
Completion: 2013-07

Publications

Fizazi 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darolutamide	Other / unclassified	200 mg	Oral
Subject	Darolutamide	Other / unclassified	400 mg	Oral
Subject	Darolutamide	Other / unclassified	600 mg	Oral
Subject	Darolutamide	Other / unclassified	1000 mg	Oral
Subject	Darolutamide	Other / unclassified	1400 mg	Oral
Subject	Darolutamide	Other / unclassified	1800 mg	Oral

Indications