Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

Phase 2

Terminated

• Conditions: Prostate Cancer
• Interventions: Drug: Degarelix

• Registration Number: NCT00215657
• Lead Sponsor: Ferring Pharmaceuticals

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 Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Results First Submitted: 2009-01-22
• Results First Submitted QC: 2009-04-24
• Results First Posted: 2009-06-12
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-18
• Last Update Posted: 2011-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 131

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Degarelix 160 mg (40 mg/mL)	Degarelix	Degarelix 160 mg (40 mg/mL)
Degarelix 120 mg (40 mg/mL)	Degarelix	Degarelix 120 mg (40 mg/mL)
Degarelix 200 mg (40 mg/mL)	Degarelix	Degarelix 200 mg (40 mg/mL)
Degarelix 120 mg (20 mg/mL)	Degarelix	Degarelix 120 mg (20 mg/mL)
Degarelix 200 mg (60 mg/mL)	Degarelix	Degarelix 200 mg (60 mg/mL)
Degarelix 240 mg (40 mg/mL)	Degarelix	Degarelix 240 mg (40 mg/mL)
Degarelix 240 mg (60 mg/mL)	Degarelix	Degarelix 240 mg (60 mg/mL)
Degarelix 320 mg (60 mg/mL)	Degarelix	Degarelix 320 mg (60 mg/mL)

Primary Outcome Measures

Name	Time	Method
Liver Function Tests	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	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.