Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer (ARAFOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01784757
Recruitment Status : Completed
First Posted : February 6, 2013
Last Update Posted : March 17, 2021
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: ODM-201 Tablet A Drug: ODM-201 Tablet B Drug: ODM-201 capsule formulation Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : March 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: ODM-201 Tablet A
ODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
 Drug: ODM-201 Tablet A
Tablet A formulation of ODM-201

Drug: ODM-201 capsule formulation
Capsule formulation of ODM-201
Experimental: ODM-201 Tablet B
ODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
 Drug: ODM-201 Tablet B
Tablet B formulation of ODM-201

Drug: ODM-201 capsule formulation
Capsule formulation of ODM-201


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Area under the curve (AUC) of ODM-201 [ Time Frame: 0-48 hrs ]
    The area under the concentration-time curve from time zero to the last sample with the quantifiable concentration calculated with linear trapezoidal rule.

  2. Cmax of ODM-201 [ Time Frame: 0-48 hrs ]
    The plasma peak concentration.


Secondary Outcome Measures :
  1. tmax of ODM-201 [ Time Frame: 0-48 hrs ]
    The time to reach peak concentration.

  2. Terminal elimination rate constant of ODM-201 [ Time Frame: 0-48 hrs ]
    The terminal elimination rate constant from log-linear portion of a concentration-time curve.

  3. Terminal elimination half-life of ODM-201 [ Time Frame: 0-48 hrs ]
    The terminal elimination half-life that will be calculated with the equation ln2/terminal elimination rate constant.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784757


Locations
Layout table for location information
Latvia
P. Stradina Clinical University Hospital
Riga, Latvia
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Endo Pharmaceuticals
Investigators
Layout table for investigator information
Principal Investigator: Karim Fizazi, MD PhD Institut Gustave Roussy, University of Paris
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01784757    
Other Study ID Numbers: 3104003
2012-002279-32 ( EudraCT Number )
First Posted: February 6, 2013    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases