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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268892
• Other study ID #: FE200486 CS15A
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 21, 2005
• Last updated: December 8, 2010
• Start date: January 2006
• Est. completion date: December 2009

Study information

• Verified date: December 2010
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaRussia: Ethics CommitteeRussia: FSI Scientific Center of Expertise of Medical ApplicationRussia: Ministry of Health of the Russian FederationRussia: Pharmacological Committee, Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)Netherlands: Independent Ethics CommitteeBelgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: Institutional Review BoardFrance: Ministry of HealthFrance: National Consultative Ethics Committee for Health and Life SciencesRomania: Ministry of Public HealthRomania: National Authority for Scientific ResearchRomania: National Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeGermany: Ministry of HealthGermany: Ethics CommissionFinland: Ethics CommitteeFinland: Finnish Medicines AgencySerbia and Montenegro: Agency for Drugs and Medicinal DevicesSerbia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: December 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 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.

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
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.
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	UZ Gasthuisberg Leuven	Leuven
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
France	Fédération d'Urologie et Néphrologie, BP69 Hôpital Pasteur	Nice
Germany	Gemeinschaftspraxis Dres Effert und Benedic	Aachen
Montenegro	Clinical Center Novi Sad, Clinic of Urology	Novi Sad
Netherlands	Academic Medical Center, Urology	Amsterdam
Netherlands	St. Elisabeth Hospital	Tilburg
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
Russian Federation	Andros Clinic	St. Petersburg
Russian Federation	City Hospital #15	St. Petersburg
Russian Federation	City Hospital #26	St. Petersburg
Russian Federation	Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department	St. Petersburg
Russian Federation	Pavlov State Medical University, Urology Department	St. Petersburg
Serbia	Clinical Center of Serbia, Institute of Urology and Nephrology	Belgrade
United Kingdom	Ward 13, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary, Majors Loans	Falkirk
United Kingdom	Castle Hill Hospital	Hull	North Humberside
United Kingdom	Mount Vernon Cancer Centre, Marie Cuire Research Wing	Northwood	Middlesex
United Kingdom	Level 7, Urology Research Unit, Derriford Hospital	Plymouth

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Finland,  France,  Germany,  Montenegro,  Netherlands,  Romania,  Russian Federation,  Serbia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight	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.	Baseline and up to 4.5 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.	4.5 years	No