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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00268892
Recruitment Status : Completed
First Posted : December 23, 2005
Results First Posted : December 6, 2010
Last Update Posted : December 24, 2010
Sponsor:
Information provided by:
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE December 21, 2005
First Posted Date  ICMJE December 23, 2005
Results First Submitted Date  ICMJE November 17, 2010
Results First Posted Date  ICMJE December 6, 2010
Last Update Posted Date December 24, 2010
Study Start Date  ICMJE January 2006
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2010)
  • Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [ Time Frame: Baseline and up to 4.5 years ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2005)
  • • 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)
Change History Complete list of historical versions of study NCT00268892 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2005)
  • • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description The data include data from the participants who participated in both the main study FE200486 CS15 (NCT00113753) and the extension study FE200486 CS15A.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2009)
278
Original Enrollment  ICMJE
 (submitted: December 21, 2005)
150
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Finland,   France,   Germany,   Montenegro,   Netherlands,   Romania,   Russian Federation,   Serbia,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00268892
Other Study ID Numbers  ICMJE FE200486 CS15A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinical Development Support, Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Development Support Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date December 2010

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