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Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC): Open, Non-Randomised, Uncontrolled, Multicentre, Dose Escalation, First-in-man Study With a Dose Expansion
The purpose of this first-in-man study is to evaluate safety, tolerability and pharmacokinetics of ODM-204 in patients with metastatic castration-resistant prostate cancer.
The safety profile of ODM-204 will be explored together with the pharmacokinetics, pharmacodynamics and tumour response to treatment with ODM-204 to recommend the dosing regimen for further clinical studies. The pharmacokinetic properties of ODM-204 will be evaluated after single and multiple dose administrations at different dose levels.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Helsinki University Central Hospital
Helsinki, Finland
Institut Gustave Roussy
Villejuif, France
P. Stradins Clinical University Hospital
Riga, Latvia
Velindre Cancer Centre
Cardiff, United Kingdom
Start Date
February 1, 2015
Primary Completion Date
January 1, 2019
Completion Date
January 1, 2019
Last Updated
December 19, 2019
23
ACTUAL participants
ODM-204
DRUG
Prednisone
DRUG
Lead Sponsor
Orion Corporation, Orion Pharma
NCT05691465
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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