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Completed

NCT Number: NCT00818623

Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients

The purpose of this trial was to find an optimal dose for a new trial drug - degarelix (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was studied. Patients participating were treated with FE200486 on one occasion. Thereafter they came in for visits following a specific schedule until blood samples showed that there was no further effect.

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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 2

Primary location

Rigshospitalet, Copenhagen, Denmark

Loading trial locations.

About this study

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent obtained before any trial related procedures
  • Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy
  • ECOG score to be equal to or above 2
  • Testosterone level within age-specific normal range
  • PSA value equal to or above 2 ng/ml
  • Life expectancy of at least 6 months

Exclusion criteria

  • Previous or current hormonal treatment of prostate cancer
  • Recent or current treatment with any drugs modifying the testosterone level
  • Candidate for curative treatment such as prostatectomy or radiotherapy
  • History of severe asthma, anaphylactic reactions or Quincke's Oedema
  • Hypersensitivity towards any component of FE200486
  • Cancer disease within the last ten years except for prostate cancer and some skin cancers
  • Signs of liver impairment shown as elevated serum ALT or serum bilirubin
  • Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
  • Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
  • Mental incapacity or language barrier
  • Having received an investigational product within the last 12 weeks preceding the trial
  • Previous participation in this trial

Treatment and study plan

degarelix

Drug

Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection

Other names: FE200486

Primary outcomes

  1. Time From Dosing Until Testosterone Levels >0.5 ng/mL

    Time frame: 3 months

    Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value >0.5 ng/mL at Day 28 onwards.

Secondary outcomes

  1. Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days

    Time frame: Two - six months

    The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 28 days.

  2. Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days

    Time frame: 3 months

    The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 84 days.

  3. Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)

    Time frame: 3 months

    Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL.

  4. Time to 50% Reduction in Prostate-specific Antigen Levels

    Time frame: 3 months

    The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 50% reduction in PSA level was reached.

  5. Time to 90% Reduction in Prostate-specific Antigen Levels

    Time frame: 3 months

    The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 90% reduction in PSA level was reached.

  6. Evaluation of Liver Function Tests

    Time frame: 3 months

    The figures presents the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.

  7. Participants With Markedly Abnormal Change in Vital Signs and Body Weight

    Time frame: 3 months

    Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

An Open-Label, Multi-Center, Parallel and Sequential, Ascending Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486 in Prostate Cancer Patients

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Jan 8, 2009
Registry last updated
Nov 30, 2023

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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