Back to resultsBioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer (ARAFOR)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
Latvia
Study Type
Interventional
Intervention
ODM-201 Tablet A
ODM-201 Tablet B
ODM-201 capsule formulation
Sponsored by
About this trial
This is an interventional basic science trial for Prostate Cancer
Eligibility Criteria
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.
Sites / Locations
- P. Stradina Clinical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ODM-201 Tablet A
ODM-201 Tablet B
Arm Description
ODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
ODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
Outcomes
Primary Outcome Measures
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.
Cmax of ODM-201
The plasma peak concentration.
Secondary Outcome Measures
tmax of ODM-201
The time to reach peak concentration.
Terminal elimination rate constant of ODM-201
The terminal elimination rate constant from log-linear portion of a concentration-time curve.
Terminal elimination half-life of ODM-201
The terminal elimination half-life that will be calculated with the equation ln2/terminal elimination rate constant.
Full Information
NCT ID
NCT01784757
First Posted
February 4, 2013
Last Updated
March 16, 2021
Sponsor
Orion Corporation, Orion Pharma
Collaborators
Endo Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01784757
Brief Title
Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
Acronym
ARAFOR
Official Title
A Bioavailability Study of ODM-201 Formulations With a Safety and Tolerability Extension Component in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orion Corporation, Orion Pharma
Collaborators
Endo Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ODM-201 Tablet A
Arm Type
Experimental
Arm Description
ODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
Arm Title
ODM-201 Tablet B
Arm Type
Experimental
Arm Description
ODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
Intervention Type
Drug
Intervention Name(s)
ODM-201 Tablet A
Intervention Description
Tablet A formulation of ODM-201
Intervention Type
Drug
Intervention Name(s)
ODM-201 Tablet B
Intervention Description
Tablet B formulation of ODM-201
Intervention Type
Drug
Intervention Name(s)
ODM-201 capsule formulation
Intervention Description
Capsule formulation of ODM-201
Primary Outcome Measure Information:
Title
Area under the curve (AUC) of ODM-201
Description
The area under the concentration-time curve from time zero to the last sample with the quantifiable concentration calculated with linear trapezoidal rule.
Time Frame
0-48 hrs
Title
Cmax of ODM-201
Description
The plasma peak concentration.
Time Frame
0-48 hrs
Secondary Outcome Measure Information:
Title
tmax of ODM-201
Description
The time to reach peak concentration.
Time Frame
0-48 hrs
Title
Terminal elimination rate constant of ODM-201
Description
The terminal elimination rate constant from log-linear portion of a concentration-time curve.
Time Frame
0-48 hrs
Title
Terminal elimination half-life of ODM-201
Description
The terminal elimination half-life that will be calculated with the equation ln2/terminal elimination rate constant.
Time Frame
0-48 hrs
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim Fizazi, MD PhD
Organizational Affiliation
Institut Gustave Roussy, University of Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
P. Stradina Clinical University Hospital
City
Riga
Country
Latvia
12. IPD Sharing Statement
Citations:
PubMed Identifier
28753851
Citation
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.
Results Reference
derived
Learn more about this trial
Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
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