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

Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC): Open, Non-Randomised, Uncontrolled, Multicentre, Dose Escalation, First-in-man Study With a Dose Expansion

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.

The safety profile of ODM-204 will be explored together with the pharmacokinetics, pharmacodynamics and tumour response to treatment with ODM-204 to recommend the dosing regimen for further clinical studies. The pharmacokinetic properties of ODM-204 will be evaluated after single and multiple dose administrations at different dose levels.

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