Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117286
• Other study ID #: FE200486 CS14A
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 30, 2005
• Last updated: September 29, 2010
• Start date: March 2005
• Est. completion date: November 2009

Study information

• Verified date: September 2010
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This was an extension study for the study FE200486 CS14 (NCT00116779). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.

The study was terminated when all ongoing participants had been treated for at least 5 years.

Description:

Participants who completed the main FE200486 CS14 study initially continued with the same dose in the FE200486 CS14A extension study. A protocol amendment changed the dosage to 160 mg (40 mg/mL) for all study participants.

The data include data from the participants who participated in both the main study (FE200486 CS14; NCT00116779) and the extension study FE200486 CS14A.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has given written consent prior to any study-related activity being performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.

• Has completed study FE200486 CS14 through visit 22.

Exclusion Criterion:

• Has been withdrawn from the FE200486 CS14 study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.

Locations

Country	Name	City	State
Canada	The Male and Female Health and Research Centers	Barrie	Ontario
Canada	Brantford Urology Research	Brantford	Ontario
Canada	Burlington Professional Care	Burlington	Ontario
Canada	The Female/Male Health Centres	Oakville	Ontario
Canada	Can-Med Clinical Research, Inc.	Victoria	British Columbia
United States	Advanced Urology Medical Center	Anaheim	California
United States	South Florida Medical Research	Aventura	Florida
United States	Urology Associate PC`	Denver	Colorado
United States	SW Florida Urological Associates	Fort Myers	Florida
United States	Northeast Indiana Research, LLC	Fort Wayne	Indiana
United States	The Urology Center	Greensboro	North Carolina
United States	Urology Centers of Alabama	Homewood	Alabama
United States	Lawrenceville Urology	Lawrenceville	New Jersey
United States	University Urological Research Institute	Providence	Rhode Island
United States	Virginia Urology Center	Richmond	Virginia
United States	Urology San Antonio Research	San Antonio	Texas
United States	Investigational site	Seattle	Washington
United States	Regional Urology	Shreveport	Louisiana
United States	University of Vermont, Dept of Surgery	South Burlington	Vermont
United States	State College Urologic Association	State College	Pennsylvania
United States	West Coast Clinical Research	Tarzana	California
United States	Western Clinical Research	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants With Markedly Abnormal Change in Vital Signs and Body Weight	This outcome measure 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 participants in each group with normal baseline and markedly abnormal value post-baseline.	5 years	No
Primary	Liver Function Tests	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.	5 years	No