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
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Enrollment: 278
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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@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).
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@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).
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268892

Locations
Belgium
UZ Gasthuisberg Leuven
Leuven, Belgium
Finland
Helsinki University Hospital, Maria Hospital, Building 11
Helsinki, Finland
Central Hospital, North Karelian
Joensuu, Finland
Oulu University Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland
France
Fédération d'Urologie et Néphrologie, BP69 Hôpital Pasteur
Nice, France
Germany
Gemeinschaftspraxis Dres Effert und Benedic
Aachen, Germany
Montenegro
Clinical Center Novi Sad, Clinic of Urology
Novi Sad, Montenegro
Netherlands
Academic Medical Center, Urology
Amsterdam, Netherlands
St. Elisabeth Hospital
Tilburg, Netherlands
Romania
"Centrul Medical Privat" Prof. Dr. Ioiart Ioan"
Arad, Romania
Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department
Bucharest, Romania
University CF Hospital No. 2
Bucharest, Romania
Russian Federation
Andros Clinic
St. Petersburg, Russian Federation
Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department
St. Petersburg, Russian Federation
City Hospital #15
St. Petersburg, Russian Federation
City Hospital #26
St. Petersburg, Russian Federation
Pavlov State Medical University, Urology Department
St. Petersburg, Russian Federation
Serbia
Clinical Center of Serbia, Institute of Urology and Nephrology
Belgrade, Serbia
United Kingdom
Mount Vernon Cancer Centre, Marie Cuire Research Wing
Northwood, Middlesex, United Kingdom
Castle Hill Hospital
Hull, North Humberside, United Kingdom
Ward 13, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary, Majors Loans
Falkirk, United Kingdom
Level 7, Urology Research Unit, Derriford Hospital
Plymouth, United Kingdom
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00268892     History of Changes
Other Study ID Numbers: FE200486 CS15A
Study First Received: December 21, 2005
Results First Received: November 17, 2010
Last Updated: December 8, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Independent Ethics Committee
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: Institutional Review Board
France: Ministry of Health
France: National Consultative Ethics Committee for Health and Life Sciences
Romania: Ministry of Public Health
Romania: National Authority for Scientific Research
Romania: National Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Germany: Ministry of Health
Germany: Ethics Commission
Finland: Ethics Committee
Finland: Finnish Medicines Agency
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Serbia: Ethics Committee

Keywords provided by Ferring Pharmaceuticals:
Prostate Cancer
Androgen ablation therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014