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

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ClinicalTrials.gov Identifier: NCT01784757
Recruitment Status : Active, not recruiting
First Posted : February 6, 2013
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

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 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
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




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.



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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.

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
Latvia
P. Stradina Clinical University Hospital
Riga, Latvia
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Endo Pharmaceuticals
Investigators
Principal Investigator: Karim Fizazi, MD PhD Institut Gustave Roussy, University of Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01784757     History of Changes
Other Study ID Numbers: 3104003
2012-002279-32 ( EudraCT Number )
First Posted: February 6, 2013    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases