Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer

Orion Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: ODM-201

Study type: Interventional

Funder types: Industry

Identifiers

NCT01317641

3104001

Details and patient eligibility

About

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

Enrollment: 136 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• Histologically confirmed adenocarcinoma of prostate
• Ongoing androgen deprivation therapy with a LHRH analogue or antagonist or bilateral orchiectomy
• Progressive metastatic disease
• Adequate bone marrow, hepatic, and renal function

Exclusion criteria

• Known metastases in the brain
• History of other malignancy within the previous 5 years
• Known gastrointestinal disease or procedure that affects the absorption
• Not able to swallow the study drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 4 patient groups

ODM-201 Phase I

Experimental group

Treatment:

Drug: ODM-201

ODM-201 Phase II Dose 1

Experimental group

Treatment:

Drug: ODM-201

ODM-201 Phase II Dose 2

Experimental group

Treatment:

Drug: ODM-201

ODM-201 Phase II Dose 3

Experimental group

Treatment:

Drug: ODM-201