SAFETY AND TOLERABILITY OF ODM-201 IN PATIENTS WITH PROSTATE CANCER: EXTENSION STUDY TO STUDY 3104001

• Conditions: Progressive castration resistant prostate cancer (MedDRA: hormone-refractory prostate cancer); MedDRA version: 16.1Level: PTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022803-24-FI
• Lead Sponsor: Orion Corporation Orion Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-15
• Last Update Posted: 8 February 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 130

Inclusion Criteria

1.Written informed consent (IC) obtained.
2.Patients who successfully completed 12 weeks of treatment according to study protocol 3104001, without any serious drug-related AEs or DLT.
3.Patient is expected to benefit from participation in the study in the opinion of the investigator.
4.Patients with any response or stable disease in study 3104001 at week 12. 5.Sexually active patients must agree to use condoms as an effective barrier method during the study treatment and for 3 months after the end of the treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

1.New serious concurrent medical condition or psychiatric illness.
2.Any condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures. 3.The patient is not able to swallow the study treatment capsules.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified