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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Degarelix
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ayr Hospital
  • Bristol Royal Infirmary
  • Southmead Hospital
  • St. Richards Hospital
  • Glan Clwyd Hospital
  • Ninewells Hospital
  • Southern General Hospital
  • Leicester General Hospital
  • Chelsea and Westminster Hospital
  • Kings College Hospital
  • St. Bartholemews Hospital
  • Derriford Hospital
  • Lister Hospital
  • Stirling Royal Infirmary
  • Morriston Hospital
  • Pindersfields General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Degarelix 80/80 + 40

Degarelix 40/40 + 40

Degarelix 80 + 20

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Testosterone <0.5 Nanogram/Milliliter

Secondary Outcome Measures

Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24
Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between 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.
Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen
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
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
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
Percentage changes in vital signs (systolic and diastolic blood pressure and pulse) and body weight at the end of trial as compared to baseline.

Full Information

First Posted
January 7, 2009
Last Updated
May 18, 2011
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00819247
Brief Title
The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
May 2002 (Actual)
Study Completion Date
August 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Degarelix 80/80 + 40
Arm Type
Experimental
Arm Description
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.
Arm Title
Degarelix 40/40 + 40
Arm Type
Experimental
Arm Description
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.
Arm Title
Degarelix 80 + 20
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
FE 200486
Intervention Description
Given as a subcutaneous injection.
Primary Outcome Measure Information:
Title
Number of Participants With Testosterone <0.5 Nanogram/Milliliter
Time Frame
Weeks 1,2,4,8,12,16,20,24
Secondary Outcome Measure Information:
Title
Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24
Time Frame
Weeks 4-24
Title
Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24
Description
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.
Time Frame
Weeks 4-24
Title
Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen
Description
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.
Time Frame
Six months
Title
Number of Participants With Normal Prostate-specific Antigen Levels During the Study
Description
The number of participants whose prostate-specific antigen levels at weeks 12 and 24 were <= 4 nanogram/millliliter (normal level).
Time Frame
Weeks 12, 24
Title
The Number of Participants With Abnormal Liver Function Tests
Description
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.
Time Frame
Six months
Title
Percentage Change in Vital Signs and Body Weight
Description
Percentage changes in vital signs (systolic and diastolic blood pressure and pulse) and body weight at the end of trial as compared to baseline.
Time Frame
Baseline and Six months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Ayr Hospital
City
Ayr
Country
United Kingdom
Facility Name
Bristol Royal Infirmary
City
Bristol
Country
United Kingdom
Facility Name
Southmead Hospital
City
Bristol
Country
United Kingdom
Facility Name
St. Richards Hospital
City
Chichester
Country
United Kingdom
Facility Name
Glan Clwyd Hospital
City
Denbighshire
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
Country
United Kingdom
Facility Name
Southern General Hospital
City
Glasgow
Country
United Kingdom
Facility Name
Leicester General Hospital
City
Leicester
Country
United Kingdom
Facility Name
Chelsea and Westminster Hospital
City
London
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
Country
United Kingdom
Facility Name
St. Bartholemews Hospital
City
London
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
Country
United Kingdom
Facility Name
Lister Hospital
City
Stevenage
Country
United Kingdom
Facility Name
Stirling Royal Infirmary
City
Stirling
Country
United Kingdom
Facility Name
Morriston Hospital
City
Swansea
Country
United Kingdom
Facility Name
Pindersfields General Hospital
City
Wakefield
Country
United Kingdom

12. IPD Sharing Statement

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

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