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Degarelix 3-month dosing in prostate cancer
NCT00468286Phase 2
Key facts
- Status
- Completed
- Start
- May 2007
- Primary completion
- Aug 2008
- Countries
- 5
- Sponsor
- Ferring Pharmaceuticals
- Modality
- Peptides, Small Molecules
- Drugs
- degarelix
- Conditions
- prostate cancer (PCa)
01
Overview
Phase 2, randomised, open-label trial of degarelix in prostate cancer (PCa) (2 arms), sponsored by Ferring Pharmaceuticals. Primary endpoint: Probability of Testosterone at Castration Level (≤0.5 ng/mL). Started May 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Degarelix 240/360 mg
Initial dose 240 mg SC on Day 0, then 360 mg SC every 3 months (Months 1, 4, 7, 10)
Degarelix 240/480 mg
Initial dose 240 mg SC on Day 0, then 480 mg SC every 3 months (Months 1, 4, 7, 10)
03
Who it enrols
Adult males with histologically proven prostate cancer requiring androgen ablation therapy, with baseline testosterone > 2.2 ng/mL and PSA >= 2 ng/mL.
04
Endpoints
Primary
Probability of Testosterone at Castration Level (≤0.5 ng/mL)
Secondary
Serum Levels of Testosterone Over Time
Probability of no PSA Failure
Serum Levels of PSA Over Time
Serum Levels of Follicle Stimulating Hormone (FSH) Over Time
Serum Levels of Luteinizing Hormone (LH) Over Time
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Liver Function Tests
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