Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer (ARAFOR)

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: ODM-201 capsule formulation; Drug: ODM-201 Tablet B; Drug: ODM-201 Tablet A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01784757

3104003

2012-002279-32 (EudraCT Number)

Details and patient eligibility

About

A study to investigate which of two different tablet formulations of ODM-201 is best suited for use in the further development of the compound in the treatment of metastatic chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing the bioavailability study will be able to receive further treatment with the current capsule formulation of ODM-201 until progression of their disease with the safety and tolerability of ODM-201 being assessed throughout.

Enrollment: 30 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent (IC) obtained.
• Histologically confirmed adenocarcinoma of prostate
• Progressive metastatic disease
• Ongoing androgen deprivation therapy with a luteinising hormone-releasing hormone (LHRH) analogue or antagonist or bilateral orchiectomy
• Adequate bone marrow, hepatic and renal function
• Able to swallow the ODM-201 whole as a capsule or tablet.

Exclusion criteria

• Previous chemotherapy for prostate cancer.
• Known metastases in the brain.
• History of other malignancy within the previous 5 years, except a basal cell carcinoma of skin.
• Known gastrointestinal condition that can significantly affect the absorption of the study treatment.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

ODM-201 Tablet A

Experimental group

Description:

ODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order.

Treatment:

Drug: ODM-201 capsule formulation

Drug: ODM-201 Tablet A

ODM-201 Tablet B

Experimental group

Description:

ODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order.

Treatment:

Drug: ODM-201 capsule formulation

Drug: ODM-201 Tablet B