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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This study has been withdrawn prior to enrollment.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
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Drug: Degarelix
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Drug Information available for: Degarelix
U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

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. [ Time Frame: 3-month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Arms Assigned Interventions
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
 Drug: Degarelix
Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.
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.
 Drug: Degarelix
Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728533

Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00728533     History of Changes
Other Study ID Numbers: FE200486 CS26, 2007-006055-39
Study First Received: January 18, 2008
Last Updated: March 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:
Prostate Cancer requiring Androgen Ablation Therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013