Open-Label, Randomised Parallel-Group Study

This study has been withdrawn prior to enrollment.
(Terminated due to awaiting data from Phase II study.)
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00728533
First received: January 18, 2008
Last updated: March 17, 2011
Last verified: March 2011

January 18, 2008
March 17, 2011
Not Provided
Not Provided
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00728533 on ClinicalTrials.gov Archive Site
  • To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment. [ Time Frame: 3-month ] [ Designated as safety issue: Yes ]
  • To evaluate pharmacokinetic response. [ Time Frame: 3-month ] [ Designated as safety issue: Yes ]
  • To compare safety and tolerability profiles of different degarelix three-month dosing regimens. [ Time Frame: 3-month ] [ Designated as safety issue: Yes ]
Same as current
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Open-Label, Randomised Parallel-Group Study
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: Degarelix
Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.
  • Experimental: 1
    • 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
    Intervention: Drug: Degarelix
  • Experimental: 2
    • 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: Drug: Degarelix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
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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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00728533
FE200486 CS26, 2007-006055-39
Yes
Clinical Development Support, Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP