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
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 1.0 nanogram/millliliter or two consecutive values between 0.5-1.0 nanogram/milliliter were withdrawn from the study due to insufficient response.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.


Enrollment: 129
Study Start Date: March 2001
Study Completion Date: August 2002
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Degarelix
Given as a subcutaneous injection.
Other Name: FE 200486
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.
Drug: Degarelix
Given as a subcutaneous injection.
Other Name: FE 200486
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.
Drug: Degarelix
Given as a subcutaneous injection.
Other Name: FE 200486

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819247

Locations
United Kingdom
Ayr Hospital
Ayr, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
Southmead Hospital
Bristol, United Kingdom
St. Richards Hospital
Chichester, United Kingdom
Glan Clwyd Hospital
Denbighshire, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Southern General Hospital
Glasgow, United Kingdom
Leicester General Hospital
Leicester, United Kingdom
St. Bartholemews Hospital
London, United Kingdom
Kings College Hospital
London, United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Lister Hospital
Stevenage, United Kingdom
Stirling Royal Infirmary
Stirling, United Kingdom
Morriston Hospital
Swansea, United Kingdom
Pindersfields General Hospital
Wakefield, United Kingdom
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00819247     History of Changes
Other Study ID Numbers: FE200486 CS02
Study First Received: January 7, 2009
Results First Received: January 22, 2009
Last Updated: May 18, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014