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Open-Label, Randomised Parallel-Group Study

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
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 requiring Androgen Ablation Therapy

Eligibility Criteria

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

Inclusion Criteria:

  • Patients, aged 18 years or older, with a histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
  • Screening testosterone level above the lower limit of normal range, globally defined as > 2.2 ng/mL.
  • Screening PSA level of =2 ng/mL. ECOG score of =2.
  • Life expectancy of at least one year.

CRITERIA FOR EVALUATION:

Primary endpoint:

  • Probability of testosterone at castrate level (=0.5 ng/mL) from Day 28 through Day 364.

Secondary endpoints:

  • Probability of testosterone at castrate level (=0.5 ng/mL) from Day 56 through Day 364.
  • Serum levels of testosterone, LH, FSH, and PSA over time.
  • Time to PSA failure - defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
  • Plasma levels of degarelix over time.
  • Frequency and severity of adverse events.
  • Clinically significant changes in laboratory safety parameters.
  • Clinically significant changes in physical examinations, ECGs, vital signs, and body weight.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    1

    2

    Arm Description

    Starting dose of 240 mg (40 mg/mL) will be given on Day 0. Maintenance doses of 360 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months

    Starting dose of 240 mg (40 mg/mL) will be given on Day 0. Maintenance doses of 480 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months.

    Outcomes

    Primary Outcome Measures

    To demonstrate efficacy of degarelix in achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) during one year of treatment in prostate cancer patients.

    Secondary Outcome Measures

    To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment.
    To evaluate pharmacokinetic response.
    To compare safety and tolerability profiles of different degarelix three-month dosing regimens.

    Full Information

    First Posted
    January 18, 2008
    Last Updated
    March 17, 2011
    Sponsor
    Ferring Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00728533
    Brief Title
    Open-Label, Randomised Parallel-Group Study
    Official Title
    The Rationale of the Study is to Demonstrate That Degarelix Given at Three-month Dosing Intervals Will Produce and Maintain Androgen Deprivation in Prostate Cancer Patients Through Immediate and Prolonged Testosterone Suppression, and to Provide Confirmatory Evidence of the Safety of Degarelix.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2011
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Terminated due to awaiting data from Phase II study.
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Ferring Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    An Open-Label, Multi-Centre, Randomised Parallel-Group Study, Investigating Efficacy and Safety of Different Degarelix Three-Month Dosing Regimens in Patients with Prostate Cancer Requiring Androgen Ablation Therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    Prostate Cancer requiring Androgen Ablation Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Starting dose of 240 mg (40 mg/mL) will be given on Day 0. Maintenance doses of 360 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Starting dose of 240 mg (40 mg/mL) will be given on Day 0. Maintenance doses of 480 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months.
    Intervention Type
    Drug
    Intervention Name(s)
    Degarelix
    Intervention Description
    Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.
    Intervention Type
    Drug
    Intervention Name(s)
    Degarelix
    Intervention Description
    Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.
    Primary Outcome Measure Information:
    Title
    To demonstrate efficacy of degarelix in achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) during one year of treatment in prostate cancer patients.
    Time Frame
    3-month
    Secondary Outcome Measure Information:
    Title
    To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment.
    Time Frame
    3-month
    Title
    To evaluate pharmacokinetic response.
    Time Frame
    3-month
    Title
    To compare safety and tolerability profiles of different degarelix three-month dosing regimens.
    Time Frame
    3-month

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients, aged 18 years or older, with a histologically proven prostate cancer of all stages in whom endocrine treatment is indicated. Screening testosterone level above the lower limit of normal range, globally defined as > 2.2 ng/mL. Screening PSA level of =2 ng/mL. ECOG score of =2. Life expectancy of at least one year. CRITERIA FOR EVALUATION: Primary endpoint: Probability of testosterone at castrate level (=0.5 ng/mL) from Day 28 through Day 364. Secondary endpoints: Probability of testosterone at castrate level (=0.5 ng/mL) from Day 56 through Day 364. Serum levels of testosterone, LH, FSH, and PSA over time. Time to PSA failure - defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir. Plasma levels of degarelix over time. Frequency and severity of adverse events. Clinically significant changes in laboratory safety parameters. Clinically significant changes in physical examinations, ECGs, vital signs, and body weight.
    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

    Open-Label, Randomised Parallel-Group Study

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