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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Degarelix
Degarelix
Degarelix
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Androgen ablation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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 Exclusion Criterion: - Has been withdrawn from the main study.

Sites / Locations

  • UZ Gasthuisberg Leuven
  • Helsinki University Hospital, Maria Hospital, Building 11
  • Central Hospital, North Karelian
  • Oulu University Hospital
  • Tampere University Hospital
  • Fédération d'Urologie et Néphrologie, BP69 Hôpital Pasteur
  • Gemeinschaftspraxis Dres Effert und Benedic
  • Clinical Center Novi Sad, Clinic of Urology
  • Academic Medical Center, Urology
  • St. Elisabeth Hospital
  • "Centrul Medical Privat" Prof. Dr. Ioiart Ioan"
  • Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department
  • University CF Hospital No. 2
  • Andros Clinic
  • City Hospital #15
  • City Hospital #26
  • Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department
  • Pavlov State Medical University, Urology Department
  • Clinical Center of Serbia, Institute of Urology and Nephrology
  • Mount Vernon Cancer Centre, Marie Cuire Research Wing
  • Castle Hill Hospital
  • Ward 13, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary, Majors Loans
  • Level 7, Urology Research Unit, Derriford Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Degarelix 240/240@40(1-3-6-9)

Degarelix 240/240@60(1-3-6-9)

Degarelix 240/240@60(1-4-7-10)

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2005
Last Updated
December 8, 2010
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00268892
Brief Title
Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Androgen ablation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Degarelix 240/240@40(1-3-6-9)
Arm Type
Experimental
Arm Description
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).
Arm Title
Degarelix 240/240@60(1-3-6-9)
Arm Type
Experimental
Arm Description
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).
Arm Title
Degarelix 240/240@60(1-4-7-10)
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
FE200486
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
FE200486
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
FE200486
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Description
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.
Time Frame
Baseline and up to 4.5 years
Title
Liver Function Tests
Description
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.
Time Frame
4.5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
UZ Gasthuisberg Leuven
City
Leuven
Country
Belgium
Facility Name
Helsinki University Hospital, Maria Hospital, Building 11
City
Helsinki
Country
Finland
Facility Name
Central Hospital, North Karelian
City
Joensuu
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Fédération d'Urologie et Néphrologie, BP69 Hôpital Pasteur
City
Nice
Country
France
Facility Name
Gemeinschaftspraxis Dres Effert und Benedic
City
Aachen
Country
Germany
Facility Name
Clinical Center Novi Sad, Clinic of Urology
City
Novi Sad
Country
Montenegro
Facility Name
Academic Medical Center, Urology
City
Amsterdam
Country
Netherlands
Facility Name
St. Elisabeth Hospital
City
Tilburg
Country
Netherlands
Facility Name
"Centrul Medical Privat" Prof. Dr. Ioiart Ioan"
City
Arad
Country
Romania
Facility Name
Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department
City
Bucharest
Country
Romania
Facility Name
University CF Hospital No. 2
City
Bucharest
Country
Romania
Facility Name
Andros Clinic
City
St. Petersburg
Country
Russian Federation
Facility Name
City Hospital #15
City
St. Petersburg
Country
Russian Federation
Facility Name
City Hospital #26
City
St. Petersburg
Country
Russian Federation
Facility Name
Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department
City
St. Petersburg
Country
Russian Federation
Facility Name
Pavlov State Medical University, Urology Department
City
St. Petersburg
Country
Russian Federation
Facility Name
Clinical Center of Serbia, Institute of Urology and Nephrology
City
Belgrade
Country
Serbia
Facility Name
Mount Vernon Cancer Centre, Marie Cuire Research Wing
City
Northwood
State/Province
Middlesex
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Hull
State/Province
North Humberside
Country
United Kingdom
Facility Name
Ward 13, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary, Majors Loans
City
Falkirk
Country
United Kingdom
Facility Name
Level 7, Urology Research Unit, Derriford Hospital
City
Plymouth
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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