A Bioavailability Study of ODM-201 Formulations With a Safety and Tolerability Extension Component in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
A Bioavailability Study of ODM-201 Formulations With a Safety and Tolerability Extension Component in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Outcome Measure:
Area under the curve (AUC) of ODM-201
Outcome Description:
The area under the concentration-time curve from time zero to the last sample with the quantifiable concentration calculated with linear trapezoidal rule.
Outcome Time Frame:
0-48 hrs
Safety Issue:
No
Principal Investigator
Karim Fizazi, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institut Gustave Roussy, University of Paris
Authority:
Finland: Finnish Medicines Agency
Study ID:
3104003
NCT ID:
NCT01784757
Start Date:
March 2013
Completion Date:
July 2014
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
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