The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00819247
First received: January 7, 2009
Last updated: May 18, 2011
Last verified: May 2011

January 7, 2009
May 18, 2011
March 2001
May 2002   (final data collection date for primary outcome measure)
Number of Participants With Testosterone <0.5 Nanogram/Milliliter [ Time Frame: Weeks 1,2,4,8,12,16,20,24 ] [ Designated as safety issue: No ]
Selection of a dosing regimen that will result in at least 70% patients with testosterone < 0.5 ng/ml after 1 week of initial dosing and at least 90% of patients with testosterone < 0.5 ng/ml in specific weeks thereafter. [ Time Frame: Six months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00819247 on ClinicalTrials.gov Archive Site
  • Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24 [ Time Frame: Weeks 4-24 ] [ Designated as safety issue: No ]
  • Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24 [ Time Frame: Weeks 4-24 ] [ Designated as safety issue: No ]
    Participants with one testoterone value > 1.0 nanogram/millliliter or two consecutive values between 0.5-1.0 nanogram/milliliter were withdrawn from the study due to insufficient response.
  • Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Participants who met at least one of the three criteria for inadequate response on prostate-specific antigen levels (PA). (1) >=25 percent and/or 50 nanogram/milliliter compared to baseline (2) reduction of <=50% compared to baseline at week 12 (3) increase of >=10 nanogram/milliliter compared to nadir from week 4.
  • Number of Participants With Normal Prostate-specific Antigen Levels During the Study [ Time Frame: Weeks 12, 24 ] [ Designated as safety issue: No ]
    The number of participants whose prostate-specific antigen levels at weeks 12 and 24 were <= 4 nanogram/millliliter (normal level).
  • The Number of Participants With Abnormal Liver Function Tests [ Time Frame: Six months ] [ Designated as safety issue: No ]
    The number of participants who had abnormal [defined as above upper limit of normal range (ULN)] alanine aminotransferase (ALT), participants with ALT increases > 3x ULN, and participants with ALT increases > 3x ULN with concurrent increases in bilirubin > 1.5 ULN.
  • Percentage Change in Vital Signs and Body Weight [ Time Frame: Baseline and Six months ] [ Designated as safety issue: No ]
    Percentage changes in vital signs (systolic and diastolic blood pressure and pulse) and body weight at the end of trial as compared to baseline.
  • Proportion of patients with testosterone < 0.5 ng/ml at all visits. [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Reduction of prostate specific antigen (PSA) compared to the value at the beginning of the trial. [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Evaluate the time course of testosterone, 5-α-dihydrotestosterone (DTH), luteinizing hormone (LH), follicle stimulating hormone (FSH) and PSA. [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Investigate the population pharmacokinetic and pharmacodynamic profile for testosterone and DTH. [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Evaluate the three dosing regimens with respect to safety and tolerability. [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
  • Estimate the proportion of patients meeting the withdrawal criteria for trial therapy with respect to testosterone and PSA. [ Time Frame: Six months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer
A Six Month, Multi-centre, Open-labelled, 1:1:1 Randomised, Parallel Group Study Investigating the Efficacy and Safety of Three Dose Regimens of FE 200486 in Prostate Cancer Patients

The purpose of this trial was to select a dose of degarelix (FE 200486). Three groups of patients were treated for six months on different doses. The patients had blood samples taken and measured for Testosterone in order to determine the most efficient dose to provide fast and sustained castration. The patients came to the clinic for 16 visits and dependent on the blood sample results they were invited to return for additional blood samples on a two weekly basis.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: Degarelix
Given as a subcutaneous injection.
Other Name: FE 200486
  • Experimental: Degarelix 80/80 + 40
    Loading doses of Degarelix 80 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140.
    Intervention: Drug: Degarelix
  • Experimental: Degarelix 40/40 + 40
    Loading doses of Degarelix 40 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140.
    Intervention: Drug: Degarelix
  • Experimental: Degarelix 80 + 20
    Loading dose of Degarelix 80 mg (20 mg/mL) on Day 0. Maintenance doses of 20 mg (10 mg/mL) given on days 28, 56, 84, 112 and 140.
    Intervention: Drug: Degarelix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
August 2002
May 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed informed consent before any trial related activity
  • Proven prostate cancer with a need for endocrine treatment
  • Testosterone level within the normal range for the age

Exclusion Criteria:

  • Previous or current hormonal treatment of prostate cancer
  • Candidate for 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
  • 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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00819247
FE200486 CS02
No
Clinical Development Support, Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP