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NCT Number: NCT01784757

Bioavailability Study of ODM-201 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

P. Stradina Clinical University Hospital

Riga, Latvia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ODM-201 Tablet A

Drug

Tablet A formulation of ODM-201

ODM-201 Tablet B

Drug

Tablet B formulation of ODM-201

ODM-201 capsule formulation

Drug

Capsule formulation of ODM-201

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Collaborators

  • Endo USA Inc., a Keenova Therapeutics Company

Registry information

Official study 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

Acronym: ARAFOR

Important dates

Study start
2013
Primary completion
2013
Study completion
2020
First posted
Feb 6, 2013
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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