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

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00268892
First received: December 21, 2005
Last updated: December 8, 2010
Last verified: December 2010

December 21, 2005
December 8, 2010
January 2006
September 2009   (final data collection date for primary outcome measure)
  • Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [ Time Frame: Baseline and up to 4.5 years ] [ Designated as safety issue: No ]
    This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.
  • Liver Function Tests [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
    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.
  • • Changes in clinical safety parameters (adverse events including death from any cause, local tolerability, physical examination, vital signs, ECG and body weight)
  • • Clinically significant changes in laboratory safety parameters (biochemistry and haematology)
Complete list of historical versions of study NCT00268892 on ClinicalTrials.gov Archive Site
Not Provided
  • • Time to testosterone serum level above 0.5 ng/mL
  • • Time to disease progression (death from any cause, introduction of additional therapy-related to the prostate cancer or PSA progression)
  • • Testosterone and PSA response over the entire treatment period.
Not Provided
Not Provided
 
Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer
An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Different Three-Month Degarelix Dosing Regimens in Patients With Prostate Cancer

The purpose of this extension study was to collect long-term safety and tolerability information to support a marketing authorisation application for a three-month dosage regimen of degarelix.

The data include data from the participants who participated in both the main study FE200486 CS15 (NCT00113753) and the extension study FE200486 CS15A.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: Degarelix

Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).

Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.

Other Name: FE200486
  • Experimental: Degarelix 240/240@40(1-3-6-9)
    Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
    Intervention: Drug: Degarelix
  • Experimental: Degarelix 240/240@60(1-3-6-9)
    Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
    Intervention: Drug: Degarelix
  • Experimental: Degarelix 240/240@60(1-4-7-10)
    Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
    Intervention: Drug: Degarelix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
278
December 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criterion:

- Has been withdrawn from the main study.

Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Finland,   France,   Germany,   Montenegro,   Netherlands,   Romania,   Russian Federation,   Serbia,   United Kingdom
 
NCT00268892
FE200486 CS15A
No
Clinical Development Support, Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP