Open-Label, Randomised Parallel-Group Study

NCT00728533 | Withdrawn Phase 3 DMC

• 2 other identifiers: FE200486 CS262007-006055-39
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer requiring Androgen Ablation Therapy

Outcome Measures

Primary Outcomes (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 Outcomes (3)

• To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment.

  3-month

• To evaluate pharmacokinetic response.

  3-month

• To compare safety and tolerability profiles of different degarelix three-month dosing regimens.

  3-month

Study Arms (2)

1

EXPERIMENTAL

* 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

2

EXPERIMENTAL

* 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

Interventions

Degarelix DRUG

Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: August 6, 2008
• Last Updated: March 18, 2011

Record last verified: 2011-03