search
Back to results

Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients

Primary Purpose

Prostate Cancer

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

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Androgen ablation therapy

Eligibility Criteria

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

Inclusion Criteria: Has completed study treatment in study FE200486 CS02. Has completed visit 16 in study FE200486 CS02. Has not met any withdrawal criteria up to and including visit 15 in FE200486 CS02

Sites / Locations

    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

    In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.

    In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.

    In the main study (FE200486 CS02; NCT00819247) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.

    Outcomes

    Primary Outcome Measures

    Liver Function Tests
    The figures present 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.
    Participants With Markedly Abnormal Change in Vital Signs and Body Weight
    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 patients in each group with normal baseline and markedly abnormal value post-baseline.

    Secondary Outcome Measures

    Serum Levels of Testosterone After 1, 2, and 3 Years

    Full Information

    First Posted
    October 26, 2005
    Last Updated
    May 18, 2011
    Sponsor
    Ferring Pharmaceuticals
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00245466
    Brief Title
    Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients
    Official Title
    An Open-Label, Multi-Centre, Extension Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Terminated
    Why Stopped
    The maintenance doses were too low to maintain testosterone suppression
    Study Start Date
    October 2001 (undefined)
    Primary Completion Date
    March 2006 (Actual)
    Study Completion Date
    March 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Ferring Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To investigate the long-term safety and tolerability of repeated doses of degarelix to prostate cancer patients
    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 (FDA regulated intervention is therefore ticked "YES"). The data include participants from both the main study (FE200486 CS02; NCT00819247) and the extension study FE200486 CS02A.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    Prostate Cancer, Androgen ablation therapy

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Degarelix 80/80 + 40
    Arm Type
    Experimental
    Arm Description
    In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
    Arm Title
    Degarelix 40/40 + 40
    Arm Type
    Experimental
    Arm Description
    In the main study (FE200486 CS02; NCT00819247) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
    Arm Title
    Degarelix 80 + 20
    Arm Type
    Experimental
    Arm Description
    In the main study (FE200486 CS02; NCT00819247) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Degarelix
    Other Intervention Name(s)
    FE200486
    Intervention Description
    Given as a subcutaneous injection once every 4 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Degarelix
    Other Intervention Name(s)
    FE200486
    Intervention Description
    Given as a subcutaneous injection once every 4 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Degarelix
    Other Intervention Name(s)
    FE200486
    Intervention Description
    Given as a subcutaneous injection once every 4 weeks.
    Primary Outcome Measure Information:
    Title
    Liver Function Tests
    Description
    The figures present 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.
    Time Frame
    3 years
    Title
    Participants With Markedly Abnormal Change in Vital Signs and Body Weight
    Description
    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 patients in each group with normal baseline and markedly abnormal value post-baseline.
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Serum Levels of Testosterone After 1, 2, and 3 Years
    Time Frame
    3 years

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Has completed study treatment in study FE200486 CS02. Has completed visit 16 in study FE200486 CS02. Has not met any withdrawal criteria up to and including visit 15 in FE200486 CS02
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Development Support
    Organizational Affiliation
    Ferring Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients

    We'll reach out to this number within 24 hrs