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

November 8, 2023 updated by: Ferring Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Ayr, United Kingdom
        • Ayr Hospital
      • Bristol, United Kingdom
        • Southmead Hospital
      • Bristol, United Kingdom
        • Bristol Royal Infirmary
      • Chichester, United Kingdom
        • St. Richards Hospital
      • Denbighshire, United Kingdom
        • Glan Clwyd Hospital
      • Dundee, United Kingdom
        • Ninewells Hospital
      • Glasgow, United Kingdom
        • Southern General Hospital
      • Leicester, United Kingdom
        • Leicester General Hospital
      • London, United Kingdom
        • Kings College Hospital
      • London, United Kingdom
        • Chelsea and Westminster Hospital
      • London, United Kingdom
        • St. Bartholemews Hospital
      • Plymouth, United Kingdom
        • Derriford Hospital
      • Stevenage, United Kingdom
        • Lister Hospital
      • Stirling, United Kingdom
        • Stirling Royal Infirmary
      • Swansea, United Kingdom
        • Morriston Hospital
      • Wakefield, United Kingdom
        • Pindersfields General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • FE 200486

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Testosterone <0.5 Nanogram/Milliliter
Time Frame: Weeks 1,2,4,8,12,16,20,24
Weeks 1,2,4,8,12,16,20,24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24
Time Frame: Weeks 4-24
Weeks 4-24
Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24
Time Frame: Weeks 4-24
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.
Weeks 4-24
Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen
Time Frame: Six months
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.
Six months
Number of Participants With Normal Prostate-specific Antigen Levels During the Study
Time Frame: Weeks 12, 24
The number of participants whose prostate-specific antigen levels at weeks 12 and 24 were <= 4 nanogram/millliliter (normal level).
Weeks 12, 24
The Number of Participants With Abnormal Liver Function Tests
Time Frame: Six months
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.
Six months
Percentage Change in Vital Signs and Body Weight
Time Frame: Baseline and Six months
Percentage changes in vital signs (systolic and diastolic blood pressure and pulse) and body weight at the end of trial as compared to baseline.
Baseline and Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Investigators

  • Study Director: Clinical Development Support, Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Actual)

May 1, 2002

Study Completion (Actual)

August 1, 2002

Study Registration Dates

First Submitted

January 7, 2009

First Submitted That Met QC Criteria

January 7, 2009

First Posted (Estimated)

January 8, 2009

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE200486 CS02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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