Open-Label, Randomised Parallel-Group Study
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Degarelix
Degarelix
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer requiring Androgen Ablation Therapy
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.
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
NCT ID
NCT00728533
First Posted
January 18, 2008
Last Updated
March 17, 2011
Sponsor
Ferring Pharmaceuticals
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
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Primary Completion Date
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Study Completion Date
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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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