Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001

Orion Pharma

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: ODM-201

Study type: Interventional

Funder types: Industry

Identifiers

NCT01429064

3104002

Details and patient eligibility

About

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

Enrollment: 76 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• Successful completion of study protocol 3104001
• Response or stable disease in study 3104001 at week 12

Exclusion criteria

• New serious concurrent medical condition
• Not able to swallow the study drug

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

ODM-201

Experimental group

Treatment:

Drug: ODM-201