NCT00268892

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started Jan 2006

Geographic Reach
10 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 6, 2010

Completed
Last Updated

December 24, 2010

Status Verified

December 1, 2010

Enrollment Period

3.7 years

First QC Date

December 21, 2005

Results QC Date

November 17, 2010

Last Update Submit

December 8, 2010

Conditions

Prostate Cancer

Keywords

Prostate CancerAndrogen ablation therapy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

DegarelixDRUG

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.

Also known as: FE200486
Degarelix 240/240@40(1-3-6-9)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • \- Has been withdrawn from the main study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

UZ Gasthuisberg Leuven

Leuven, Belgium

Location

Helsinki University Hospital, Maria Hospital, Building 11

Helsinki, Finland

Location

Central Hospital, North Karelian

Joensuu, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Fédération d'Urologie et Néphrologie, BP69 Hôpital Pasteur

Nice, France

Location

Gemeinschaftspraxis Dres Effert und Benedic

Aachen, Germany

Location

Clinical Center Novi Sad, Clinic of Urology

Novi Sad, Montenegro

Location

Academic Medical Center, Urology

Amsterdam, Netherlands

Location

St. Elisabeth Hospital

Tilburg, Netherlands

Location

"Centrul Medical Privat" Prof. Dr. Ioiart Ioan"

Arad, Romania

Location

Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department

Bucharest, Romania

Location

University CF Hospital No. 2

Bucharest, Romania

Location

Andros Clinic

Saint Petersburg, Russia

Location

City Hospital #15

Saint Petersburg, Russia

Location

City Hospital #26

Saint Petersburg, Russia

Location

Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department

Saint Petersburg, Russia

Location

Pavlov State Medical University, Urology Department

Saint Petersburg, Russia

Location

Clinical Center of Serbia, Institute of Urology and Nephrology

Belgrade, Serbia

Location

Mount Vernon Cancer Centre, Marie Cuire Research Wing

Northwood, Middlesex, United Kingdom

Location

Castle Hill Hospital

Hull, North Humberside, United Kingdom

Location

Ward 13, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary, Majors Loans

Falkirk, United Kingdom

Location

Level 7, Urology Research Unit, Derriford Hospital

Plymouth, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Ferring Pharmaceuticals
Organization
Clinical Development Support
DK0-Disclosure@ferring.com

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 23, 2005

Study Start

January 1, 2006

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

December 24, 2010

Results First Posted

December 6, 2010

Record last verified: 2010-12

Locations

RU(5)GB(4)FR(1)FI(4)SE(1)BE(1)NL(2)DE(1)MO(1)RO(3)