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A Long Term Safety Study of Degarelix in Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
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 Safety parameters, ECG, blood and urine samples, general health state

Eligibility Criteria

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

Inclusion Criteria:

  • Completed any of the trials; FE 200486 CS27, CS28, CS30 or CS31

Exclusion Criteria:

  • Discontinued any of the trials: FE 200486 CS27, CS28, CS30 or CS31

Sites / Locations

  • Institut Jules Bordet
  • St. Elisabethziekenhuis
  • Hopital Jean Minjoz
  • Institut Bergonié
  • Centre Francois Baclesse
  • CHU Henri Mondor
  • Centre Oscar Lambret
  • Centre Leon Berard
  • Hopital de la Timone
  • CRLC Val d' Aurelle - Oncology Radiotherapy
  • Hôpital Saint Louis - Radiotherapy Departement
  • Hôpital Tenon
  • Clinique Francheville
  • CHU La Milétrie - Oncology Radiotherapy
  • Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau
  • Institut de Cancérologie de la Loire
  • Clinique Saint Brieuc
  • Centre Paul Strauss
  • Centre de radiologie Saint Louis
  • Clinique du Parc
  • IGR
  • Azienda Ospedaliero Universitaria Ospedali riuniti
  • Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna
  • Clinica Urologica 1 Universita Firenze
  • Fondazione IRCCS Istituto Nazionale Tumori
  • Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
  • Azienda Ospedaliera Universitaria Federico II
  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo
  • Clinica Urologica - Azienda Ospedaliera di Perugia
  • Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma
  • S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza
  • Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette
  • Hospital Fernando da Fonseca
  • Hospitais Universidade Coimbra
  • Centro Hospitalar Lisboa Norte, Hospital Santa Maria
  • Hospital S.João
  • Hospital Universitario Principe de Asturias
  • Fundacion Hospital Alcorcón
  • Fundación Puigvert
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitari Vall d´Hebron
  • Hospital de Basurto
  • Hospital Clinico Universitario S. Carlos
  • Hospital Doce de Octubre
  • Hospital universitario Ramón y Cajal
  • Hospital Universitario Puerta de Hierro
  • Hospital Manacor
  • Hospital Universitario Central de Asturias
  • Hospital Santiago de Compostela
  • Hospital Virgen Macarena
  • Fundación IVO
  • Hospital Xeral de Vigo
  • Investigational site
  • SU/Sahlgrenska
  • Helsingborgs Lasarett
  • Universitetssjukhuset MAS
  • Södertälje Sjukhus
  • Uppsala/Akademiska sjukhuset
  • Ankara University Faculty of Medicine - Sıhhıye
  • Cerrahpasa Faculty of Medicine - Kocamustafapasa
  • Istanbul University Faculty of Medicine - ÇAPA
  • Marmara University Faculty of Medicine - Altunizade

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Degarelix

Arm Description

The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.

Outcomes

Primary Outcome Measures

Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.

Secondary Outcome Measures

Full Information

First Posted
August 18, 2009
Last Updated
January 2, 2013
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00967018
Brief Title
A Long Term Safety Study of Degarelix in Patients With Prostate Cancer
Official Title
A Phase IIIb, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Safety parameters, ECG, blood and urine samples, general health state

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Degarelix
Arm Type
Experimental
Arm Description
The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
Intervention Type
Drug
Intervention Name(s)
Degarelix
Primary Outcome Measure Information:
Title
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Description
The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Time Frame
Up to 22.5 months
Title
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Description
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Time Frame
Up to 22.5 months
Other Pre-specified Outcome Measures:
Title
Serum Levels of Prostate Specific Antigen (PSA)Over Time
Description
PSA levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)
Time Frame
from baseline to 72 weeks
Title
Serum Levels of Testosterone Over Time
Description
Testosterone levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)
Time Frame
from baseline to week 72

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed any of the trials; FE 200486 CS27, CS28, CS30 or CS31 Exclusion Criteria: Discontinued any of the trials: FE 200486 CS27, CS28, CS30 or CS31
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
Institut Jules Bordet
City
Bruxelles
Country
Belgium
Facility Name
St. Elisabethziekenhuis
City
Turnhout
Country
Belgium
Facility Name
Hopital Jean Minjoz
City
Besancon
Country
France
Facility Name
Institut Bergonié
City
Bordeaux Cedex
Country
France
Facility Name
Centre Francois Baclesse
City
Caen
Country
France
Facility Name
CHU Henri Mondor
City
Creteil
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Facility Name
Centre Leon Berard
City
Lyon
Country
France
Facility Name
Hopital de la Timone
City
Marseille, Cedex
Country
France
Facility Name
CRLC Val d' Aurelle - Oncology Radiotherapy
City
Montpellier
Country
France
Facility Name
Hôpital Saint Louis - Radiotherapy Departement
City
Paris
Country
France
Facility Name
Hôpital Tenon
City
Paris
Country
France
Facility Name
Clinique Francheville
City
Perigueux
Country
France
Facility Name
CHU La Milétrie - Oncology Radiotherapy
City
Poitiers
Country
France
Facility Name
Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau
City
Saint Herblain Cedex
Country
France
Facility Name
Institut de Cancérologie de la Loire
City
Saint Priest en Jarez
Country
France
Facility Name
Clinique Saint Brieuc
City
St Brieuc Cedex
Country
France
Facility Name
Centre Paul Strauss
City
Strassbourg
Country
France
Facility Name
Centre de radiologie Saint Louis
City
Toulon
Country
France
Facility Name
Clinique du Parc
City
Toulouse
Country
France
Facility Name
IGR
City
Villejuif
Country
France
Facility Name
Azienda Ospedaliero Universitaria Ospedali riuniti
City
Ancona
Country
Italy
Facility Name
Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna
City
Bologna
Country
Italy
Facility Name
Clinica Urologica 1 Universita Firenze
City
Firenze
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale Tumori
City
Milano
Country
Italy
Facility Name
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo
City
Palermo
Country
Italy
Facility Name
Clinica Urologica - Azienda Ospedaliera di Perugia
City
Perugia
Country
Italy
Facility Name
Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma
City
Roma
Country
Italy
Facility Name
S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette
City
Torino
Country
Italy
Facility Name
Hospital Fernando da Fonseca
City
Amadora
Country
Portugal
Facility Name
Hospitais Universidade Coimbra
City
Coimbra
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Norte, Hospital Santa Maria
City
Lisboa
Country
Portugal
Facility Name
Hospital S.João
City
Porto
Country
Portugal
Facility Name
Hospital Universitario Principe de Asturias
City
Alcalá de Henares-Madrid
Country
Spain
Facility Name
Fundacion Hospital Alcorcón
City
Alcorcon
Country
Spain
Facility Name
Fundación Puigvert
City
Barcelona
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari Vall d´Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
Country
Spain
Facility Name
Hospital Clinico Universitario S. Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Doce de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital universitario Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
Country
Spain
Facility Name
Hospital Manacor
City
Manacor
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
Country
Spain
Facility Name
Hospital Santiago de Compostela
City
Santiago de Compostela
Country
Spain
Facility Name
Hospital Virgen Macarena
City
Sevilla
Country
Spain
Facility Name
Fundación IVO
City
Valencia
Country
Spain
Facility Name
Hospital Xeral de Vigo
City
Vigo
Country
Spain
Facility Name
Investigational site
City
Göteborg
Country
Sweden
Facility Name
SU/Sahlgrenska
City
Göteborg
Country
Sweden
Facility Name
Helsingborgs Lasarett
City
Helsingborg
Country
Sweden
Facility Name
Universitetssjukhuset MAS
City
Malmö
Country
Sweden
Facility Name
Södertälje Sjukhus
City
Södertälje
Country
Sweden
Facility Name
Uppsala/Akademiska sjukhuset
City
Uppsala
Country
Sweden
Facility Name
Ankara University Faculty of Medicine - Sıhhıye
City
Ankara
Country
Turkey
Facility Name
Cerrahpasa Faculty of Medicine - Kocamustafapasa
City
Istanbul
Country
Turkey
Facility Name
Istanbul University Faculty of Medicine - ÇAPA
City
Istanbul
Country
Turkey
Facility Name
Marmara University Faculty of Medicine - Altunizade
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

A Long Term Safety Study of Degarelix in Patients With Prostate Cancer

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