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OpenTrials
Completed

NCT Number: NCT02468284

Pharmacokinetics of Degarelix in Chinese Patients With Prostate Cancer

The purpose of this trial is to look at how much a new trial drug get into body, such as when the drug concentration in your body reaches peak and how high the peak value is.

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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

Peking University Third Hospital (there may be other sites in this country)

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), for which endocrine therapy (except for neoadjuvant hormonal therapy) is indicated
  • Has a Prostate-specific Antigen (PSA) level ≥2.0 ng/mL at Screening
  • Has a screening serum testosterone level >150 ng/dL
  • Has an Eastern Cooperative Oncology Group (ECOG) score of ≤2

Exclusion criteria

  • Has had previous or is currently under hormonal management of prostate cancer. However, hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to the Screening Visit
  • Is currently treated with a 5-alpha reductase inhibitor
  • Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
  • Is in need of neoadjuvant hormonal therapy
  • Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy

Treatment and study plan

degarelix

Drug

Other names: Firmagon

Primary outcomes

  1. Maximum plasma concentration observed (Cmax)

    Time frame: Day 0 - 196

  2. Time of Cmax after subcutaneous administration (Tmax)

    Time frame: Day 0 - 196

  3. Maximum plasma concentration observed (Cmax)

    Time frame: Day 0 - 28

  4. Maximum plasma concentration observed (Cmax)

    Time frame: Day 168 - 196

  5. Time of Cmax after subcutaneous administration (Tmax)

    Time frame: Day 0 - 28

  6. Time of Cmax after subcutaneous administration (Tmax)

    Time frame: Day 168 - 196

  7. Area under the plasma concentration-time curve during a drug dosing interval (AUC)

    Time frame: Day 0 - 28

  8. Area under the plasma concentration-time curve during a drug dosing interval (AUC)

    Time frame: Day 168 - 196

Secondary outcomes

  1. Plasma trough levels of degarelix

    Time frame: At Days 28, 56, 168 and 196

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

An Open-label, Multi-Centre Trial Investigating Pharmacokinetics of Degarelix After a Starting Dose of 240 mg (40 mg/mL) Followed by Six Maintenance Doses of 80 mg (20 mg/mL) in Chinese Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 10, 2015
Registry last updated
Oct 26, 2017

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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