An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Ferring Pharmaceuticals
- Enrollment
- 131
- Primary Endpoint
- Liver Function Tests
Study Overview
Brief Summary
An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Detailed Description
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention (FDA regulated intervention is therefore ticked "YES").
The data include participants from both the main study (FE200486 CS07; NCT00818623) and the extension study FE200486 CS07A.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males aged 18 or over
- •Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)
- •Has completed Study FE200486 CS07
- •Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07
Exclusion Criteria
- Not provided
Arms & Interventions
Degarelix 120 mg (20 mg/mL)
Degarelix 120 mg (20 mg/mL)
Intervention: Degarelix (Drug)
Degarelix 120 mg (40 mg/mL)
Degarelix 120 mg (40 mg/mL)
Intervention: Degarelix (Drug)
Degarelix 160 mg (40 mg/mL)
Degarelix 160 mg (40 mg/mL)
Intervention: Degarelix (Drug)
Degarelix 200 mg (40 mg/mL)
Degarelix 200 mg (40 mg/mL)
Intervention: Degarelix (Drug)
Degarelix 200 mg (60 mg/mL)
Degarelix 200 mg (60 mg/mL)
Intervention: Degarelix (Drug)
Degarelix 240 mg (40 mg/mL)
Degarelix 240 mg (40 mg/mL)
Intervention: Degarelix (Drug)
Degarelix 240 mg (60 mg/mL)
Degarelix 240 mg (60 mg/mL)
Intervention: Degarelix (Drug)
Degarelix 320 mg (60 mg/mL)
Degarelix 320 mg (60 mg/mL)
Intervention: Degarelix (Drug)
Outcomes
Primary Outcomes
Liver Function Tests
Time Frame: 3 years
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN.
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Time Frame: 3 years
Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.
Secondary Outcomes
No secondary outcomes reported