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Open-Label, Randomised Parallel-Group Study

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00728533
Collaborator
(none)
0
Enrollment
2
Arms

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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.

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. 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. [3-month]

Secondary Outcome Measures

  1. To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment. [3-month]

  2. To evaluate pharmacokinetic response. [3-month]

  3. To compare safety and tolerability profiles of different degarelix three-month dosing regimens. [3-month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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
Secondary endpoints:
  • Probability of testosterone at castrate level (=0.5 ng/mL) from Day 56 through Day

  • 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

Locations

No locations specified.

Sponsors and Collaborators

  • Ferring Pharmaceuticals

Investigators

  • Study Director: Clinical Development Support, Ferring Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00728533
Other Study ID Numbers:
  • FE200486 CS26
  • 2007-006055-39
First Posted:
Aug 6, 2008
Last Update Posted:
Mar 18, 2011
Last Verified:
Mar 1, 2011
Keywords provided by , ,
Prostate Cancer requiring Androgen Ablation Therapy
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Mar 18, 2011