First-in-man study of ODM-204 in patients with CRPC: DUALIDES
Research type
Research Study
Full title
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.
IRAS ID
167335
Contact name
Rob Jones
Contact email
Sponsor organisation
Orion Corporation Orion Pharma
Eudract number
2014-003642-26
Duration of Study in the UK
2 years, 6 months, 16 days
Research summary
This clinical study investigates a new treatment for prostate cancer, the most common cancer in European men and a leading cause of cancer-related deaths. ODM-204 is a new product and will be administered (along with Prednison®) to humans for the first time in this study. The main purpose of the study is to find a dose of ODM-204 that has antitumor activity and is tolerable and safe in the treatment of prostate cancer in patients with castrate-resistant prostate cancer, (CRPC) and to define the dose(s) for the further clinical studies.
ODM-204 was shown to have significant anti-tumour activity in animal models of prostate cancer. The results suggest that ODM-204 may have therapeutic potential to be an effective treatment for men with CRPC.
This is an open, uncontrolled, non-randomised study and is planned to run in approximately 15 study hospitals in Europe. Approximately 50 patients with progressive metastatic CRPC are planned to be enrolled in the phase I dose escalation component of the study, and approximately 45 patients with progressive metastatic CRPC are planned to be enrolled in the phase II expansion component.
The study consists of a screening period of a maximum 14 days, a treatment period lasting until disease progression or an intolerable adverse event, and a post-treatment period of 28 days after the last dose of ODM-204.REC name
Wales REC 2
REC reference
15/WA/0010
Date of REC Opinion
20 Feb 2015
REC opinion
Further Information Favourable Opinion