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

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Collaborator: Endo Pharmaceuticals

Criteria

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.