NCT02344017

Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	ODM-204	co-administered with prednisone, orally daily
DRUG	Prednisone	ODM-204 is co-administered with oral prednisone

Timeline

• Start date: 2015-02-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2015-01-22
• Last updated: 2019-12-19

Locations

4 sites across 4 countries: Finland, France, Latvia, United Kingdom