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

Orion Corporation, Orion Pharma76 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

ODM-201DRUG

ODM-201 administered orally daily

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

The Urology Center of Colorado

Wheat Ridge, Colorado, United States

Eastern CT Hematology and Oncology Associates

Norwich, Connecticut, United States

Outcomes

Primary Outcomes

Number of Participants With Adverse Events

Adverse events from start of ODM-201 treatment (in ARADES 3104001 study) until end of study visit (in ARADES-EXT 3104002 study). Median duration on study treatment was 11,0 months.

Time frame: From first dose of study treatment up to 4 weeks after last dose of study treatment

Data from ClinicalTrials.gov

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