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

March 16, 2021 updated by: Orion Corporation, Orion Pharma

A Bioavailability Study of ODM-201 Formulations With a Safety and Tolerability Extension Component in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Latvia
      • Riga, Latvia
        • P. Stradina Clinical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 capsule formulation
Capsule formulation of ODM-201
Drug: ODM-201 Tablet B
Tablet B formulation of ODM-201

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-48 hrs
Cmax of ODM-201
Time Frame: 0-48 hrs
The plasma peak concentration.
0-48 hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tmax of ODM-201
Time Frame: 0-48 hrs
The time to reach peak concentration.
0-48 hrs
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.
0-48 hrs
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.
0-48 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orion Corporation, Orion Pharma

Collaborators

Endo Pharmaceuticals

Investigators

  • Principal Investigator: Karim Fizazi, MD PhD, Institut Gustave Roussy, University of Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

February 4, 2013

First Posted (Estimate)

February 6, 2013

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3104003
  • 2012-002279-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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