Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer
This study has been completed.
Sponsor:
Ferring Pharmaceuticals
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00268892
First received: December 21, 2005
Last updated: December 8, 2010
Last verified: December 2010
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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
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: Directorate general for the protection of Public health: Medicines 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 May 16, 2013