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

Orion Pharma

Status and phase

Completed

Phase 2

Phase 1

Conditions

Prostate Cancer

Treatments

Drug: ODM-204

Drug: Prednisone

Study type

Interventional

Funder types

Industry

Identifiers

NCT02344017

3116001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

23 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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