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Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Degarelix
Degarelix
Degarelix
Degarelix
Degarelix
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

Eligibility Criteria

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

Inclusion Criteria: Males aged 18 or over Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy) Has completed Study FE200486 CS07 Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Degarelix 120 mg (20 mg/mL)

    Degarelix 120 mg (40 mg/mL)

    Degarelix 160 mg (40 mg/mL)

    Degarelix 200 mg (40 mg/mL)

    Degarelix 200 mg (60 mg/mL)

    Degarelix 240 mg (40 mg/mL)

    Degarelix 240 mg (60 mg/mL)

    Degarelix 320 mg (60 mg/mL)

    Arm Description

    Degarelix 120 mg (20 mg/mL)

    Degarelix 120 mg (40 mg/mL)

    Degarelix 160 mg (40 mg/mL)

    Degarelix 200 mg (40 mg/mL)

    Degarelix 200 mg (60 mg/mL)

    Degarelix 240 mg (40 mg/mL)

    Degarelix 240 mg (60 mg/mL)

    Degarelix 320 mg (60 mg/mL)

    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

    Full Information

    First Posted
    September 20, 2005
    Last Updated
    May 18, 2011
    Sponsor
    Ferring Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00215657
    Brief Title
    Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
    Official Title
    An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Terminated
    Why Stopped
    The doses were not effective in maintaining testosterone suppression
    Study Start Date
    March 2003 (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
    An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in 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 CS07; NCT00818623) and the extension study FE200486 CS07A.

    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
    131 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Degarelix 120 mg (20 mg/mL)
    Arm Type
    Experimental
    Arm Description
    Degarelix 120 mg (20 mg/mL)
    Arm Title
    Degarelix 120 mg (40 mg/mL)
    Arm Type
    Experimental
    Arm Description
    Degarelix 120 mg (40 mg/mL)
    Arm Title
    Degarelix 160 mg (40 mg/mL)
    Arm Type
    Experimental
    Arm Description
    Degarelix 160 mg (40 mg/mL)
    Arm Title
    Degarelix 200 mg (40 mg/mL)
    Arm Type
    Experimental
    Arm Description
    Degarelix 200 mg (40 mg/mL)
    Arm Title
    Degarelix 200 mg (60 mg/mL)
    Arm Type
    Experimental
    Arm Description
    Degarelix 200 mg (60 mg/mL)
    Arm Title
    Degarelix 240 mg (40 mg/mL)
    Arm Type
    Experimental
    Arm Description
    Degarelix 240 mg (40 mg/mL)
    Arm Title
    Degarelix 240 mg (60 mg/mL)
    Arm Type
    Experimental
    Arm Description
    Degarelix 240 mg (60 mg/mL)
    Arm Title
    Degarelix 320 mg (60 mg/mL)
    Arm Type
    Experimental
    Arm Description
    Degarelix 320 mg (60 mg/mL)
    Intervention Type
    Drug
    Intervention Name(s)
    Degarelix
    Other Intervention Name(s)
    FE200486
    Intervention Description
    Degarelix 120 mg (20 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
    Intervention Type
    Drug
    Intervention Name(s)
    Degarelix
    Other Intervention Name(s)
    FE200486
    Intervention Description
    Degarelix 120 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
    Intervention Type
    Drug
    Intervention Name(s)
    Degarelix
    Other Intervention Name(s)
    FE200486
    Intervention Description
    Degarelix 160 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
    Intervention Type
    Drug
    Intervention Name(s)
    Degarelix
    Other Intervention Name(s)
    FE200486
    Intervention Description
    Degarelix 200 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
    Intervention Type
    Drug
    Intervention Name(s)
    Degarelix
    Other Intervention Name(s)
    FE200486
    Intervention Description
    Degarelix 200 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
    Intervention Type
    Drug
    Intervention Name(s)
    Degarelix
    Other Intervention Name(s)
    FE200486
    Intervention Description
    Degarelix 240 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
    Intervention Type
    Drug
    Intervention Name(s)
    Degarelix
    Other Intervention Name(s)
    FE200486
    Intervention Description
    Degarelix 240 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
    Intervention Type
    Drug
    Intervention Name(s)
    Degarelix
    Other Intervention Name(s)
    FE200486
    Intervention Description
    Degarelix 320 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
    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

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Males aged 18 or over Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy) Has completed Study FE200486 CS07 Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07
    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

    Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

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