Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer

• Status: Completed
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this first-in-man study is to evaluate safety, tolerability and pharmacokinetics of ODM-204 in patients with metastatic castration-resistant prostate cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Treatments: Prednisone

Criteria

Inclusion Criteria:

• Written informed consent (IC) obtained.

• Male aged ≥ 18 years.

• Histologically or cytologically confirmed adenocarcinoma of prostate.

• Ongoing GnRH agonist or antagonist therapy, or after bilateral orchiectomy.

• Progressive metastatic disease

• Adequate bone marrow, hepatic, and renal function

• Acceptable and regular bowel movements without any GI disorder or procedure which may interfere with absorption of study treatment

• Ability to swallow study treatments

Exclusion Criteria:

• History of pituitary or adrenal dysfunction.

• Known brain metastases.

• Active infection or other medical condition that would make prednisone (corticosteroid) contraindicated.

• Uncontrolled hypertension

• Clinically significant heart disease

• Prolonged QTc interval