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Completed

NCT Number: NCT02344017

Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer

The purpose of this first-in-man study is to evaluate safety, tolerability and pharmacokinetics of ODM-204 in patients with metastatic castration-resistant prostate cancer.

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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 / Phase 2

Primary location

Helsinki University Central Hospital, Helsinki, Finland

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About this study

The safety profile of ODM-204 will be explored together with the pharmacokinetics, pharmacodynamics and tumour response to treatment with ODM-204 to recommend the dosing regimen for further clinical studies. The pharmacokinetic properties of ODM-204 will be evaluated after single and multiple dose administrations at different dose levels.

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.
  • Male aged ≥ 18 years.
  • Histologically or cytologically confirmed adenocarcinoma of prostate.
  • Ongoing GnRH agonist or antagonist therapy, or after bilateral orchiectomy.
  • Progressive metastatic disease
  • Adequate bone marrow, hepatic, and renal function
  • Acceptable and regular bowel movements without any GI disorder or procedure which may interfere with absorption of study treatment
  • Ability to swallow study treatments

Exclusion criteria

  • History of pituitary or adrenal dysfunction.
  • Known brain metastases.
  • Active infection or other medical condition that would make prednisone (corticosteroid) contraindicated.
  • Uncontrolled hypertension
  • Clinically significant heart disease
  • Prolonged QTc interval

Treatment and study plan

ODM-204

Drug

co-administered with prednisone, orally daily

Prednisone

Drug

ODM-204 is co-administered with oral prednisone

Primary outcomes

  1. Safety and tolerability assessed by incidence of adverse events

    Time frame: Until disease progression, an expected average of 6 months

  2. Safety and tolerability assessed by vitals signs and 12-lead ECG

    Time frame: Until disease progression, an expected average of 6 months

  3. Safety and tolerability assessed by laboratory assessments

    Time frame: Until disease progression, an expected average of 6 months

Secondary outcomes

  1. Pharmacokinetic profile assessed by plasma peak concentration (Cmax)

    Time frame: 0 - week 12

  2. Pharmacokinetic profile assessed by area under the concentration-time curve (AUC)

    Time frame: 0 - week 12

  3. Pharmacokinetic profile assessed by time to reach peak concentration (tmax)

    Time frame: 0 - week 12

  4. Preliminary antitumour activity assessed by prostate specific antigen (PSA) response

    Time frame: Until disease progression, an expected average of 6 months

  5. Preliminary antitumour activity assessed by response in soft and bone tissues

    Time frame: Until disease progression, an expected average of 6 months

  6. Pharmacodynamic profile assessed by hormone and circulating tumour cell measurements

    Time frame: 0 - week 12

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC): Open, Non-Randomised, Uncontrolled, Multicentre, Dose Escalation, First-in-man Study With a Dose Expansion

Acronym: DUALIDES

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 22, 2015
Registry last updated
Dec 19, 2019

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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