Trial intelligence / Profile preview

Degarelix dosing regimens in prostate cancer

NCT00819156Phase 2

Key facts

Status: Completed
Start: Feb 2004
Primary completion: Jun 2005
Countries: 8
Sponsor: Ferring Pharmaceuticals
Modality: Peptides, Small Molecules

Drugs: degarelix
Conditions: prostate cancer (PCa)

Overview

Phase 2, randomised, open-label trial of degarelix in prostate cancer (PCa) (6 arms), sponsored by Ferring Pharmaceuticals. Primary endpoint: Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364. Started Feb 2004; status: completed.

Design

6 arms

Study design: RandomizedOpen-label

Degarelix 200/80
200 mg loading, 80 mg maintenance
Degarelix 200/120
200 mg loading, 120 mg maintenance
Degarelix 200/160
200 mg loading, 160 mg maintenance
Degarelix 240/80
240 mg loading, 80 mg maintenance
Degarelix 240/120
240 mg loading, 120 mg maintenance
Degarelix 240/160
240 mg loading, 160 mg maintenance

Who it enrols

Patients with proven prostate cancer in need of endocrine treatment, PSA >= 2 ng/ml, and ECOG >= 2.

Endpoints

Primary

Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 36412 months

Secondary

Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28Day 28 - 364
Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28Day 28
Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3Day 3
Days to 50 Percent Reduction in Prostate-Specific AntigenDay 0 to Day 364
Days to 90 Percent Reduction in Prostate-Specific AntigenDay 0 to Day 364
Days to Prostate-Specific Antigen ProgressionDay 0 to Day 364
Median Serum Testosterone LevelsDay 364
Median Prostate-specific Antigen LevelsDay 364

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