Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
ARAFOR
A Bioavailability Study of ODM-201 Formulations With a Safety and Tolerability Extension Component in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
2 other identifiers
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 prostate-cancer
Started Mar 2013
Longer than P75 for phase_1 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2013
CompletedFirst Posted
Study publicly available on registry
February 6, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMarch 17, 2021
March 1, 2021
5 months
February 4, 2013
March 16, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Area under the curve (AUC) of ODM-201
The area under the concentration-time curve from time zero to the last sample with the quantifiable concentration calculated with linear trapezoidal rule.
0-48 hrs
Cmax of ODM-201
The plasma peak concentration.
0-48 hrs
Secondary Outcomes (3)
tmax of ODM-201
0-48 hrs
Terminal elimination rate constant of ODM-201
0-48 hrs
Terminal elimination half-life of ODM-201
0-48 hrs
Study Arms (2)
ODM-201 Tablet A
EXPERIMENTALODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
ODM-201 Tablet B
EXPERIMENTALODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Orion Corporation, Orion Pharmalead
- Endo Pharmaceuticalscollaborator
Study Sites (1)
P. Stradina Clinical University Hospital
Riga, Latvia
Related Publications (1)
Shore ND, Tammela TL, Massard C, Bono P, Aspegren J, Mustonen M, Fizazi K. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naive and CYP17 Inhibitor-naive Patients: Follow-up from the ARADES and ARAFOR Trials. Eur Urol Focus. 2018 Jul;4(4):547-553. doi: 10.1016/j.euf.2017.01.015. Epub 2017 Feb 14.
PMID: 28753851DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karim Fizazi, MD PhD
Institut Gustave Roussy, University of Paris
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2013
First Posted
February 6, 2013
Study Start
March 1, 2013
Primary Completion
August 1, 2013
Study Completion
December 1, 2020
Last Updated
March 17, 2021
Record last verified: 2021-03