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

January 2, 2013 updated by: Ferring Pharmaceuticals

A Phase IIIb, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients With Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium
        • Institut Jules Bordet
      • Turnhout, Belgium
        • St. Elisabethziekenhuis
  • France
      • Besancon, France
        • Hôpital Jean Minjoz
      • Bordeaux Cedex, France
        • Institut Bergonie
      • Caen, France
        • Centre François Baclesse
      • Creteil, France
        • CHU Henri Mondor
      • Lille, France
        • Centre Oscar Lambret
      • Lyon, France
        • Centre Leon Berard
      • Marseille, Cedex, France
        • Hôpital de la Timone
      • Montpellier, France
        • CRLC Val d' Aurelle - Oncology Radiotherapy
      • Paris, France
        • Hopital Tenon
      • Paris, France
        • Hôpital Saint Louis - Radiotherapy Departement
      • Perigueux, France
        • Clinique Francheville
      • Poitiers, France
        • CHU La Milétrie - Oncology Radiotherapy
      • Saint Herblain Cedex, France
        • Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau
      • Saint Priest en Jarez, France
        • Institut de Cancerologie de La Loire
      • St Brieuc Cedex, France
        • Clinique Saint Brieuc
      • Strassbourg, France
        • Centre Paul Strauss
      • Toulon, France
        • Centre de radiologie Saint Louis
      • Toulouse, France
        • Clinique du Parc
      • Villejuif, France
        • IGR
  • Italy
      • Ancona, Italy
        • Azienda Ospedaliero Universitaria Ospedali Riuniti
      • Bologna, Italy
        • Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna
      • Firenze, Italy
        • Clinica Urologica 1 Universita Firenze
      • Milano, Italy
        • Fondazione IRCCS Istituto Nazionale Tumori
      • Milano, Italy
        • Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
      • Napoli, Italy
        • Azienda Ospedaliera Universitaria Federico Ii
      • Palermo, Italy
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo
      • Perugia, Italy
        • Clinica Urologica - Azienda Ospedaliera di Perugia
      • Roma, Italy
        • Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma
      • San Giovanni Rotondo, Italy
        • S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza
      • Torino, Italy
        • Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette
  • Portugal
      • Amadora, Portugal
        • Hospital Fernando da Fonseca
      • Coimbra, Portugal
        • Hospitais Universidade Coimbra
      • Lisboa, Portugal
        • Centro Hospitalar Lisboa Norte, Hospital Santa Maria
      • Porto, Portugal
        • Hospital S.JOÃO
  • Spain
      • Alcalá de Henares-Madrid, Spain
        • Hospital Universitario Príncipe de Asturias
      • Alcorcon, Spain
        • Fundacion Hospital Alcorcon
      • Barcelona, Spain
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain
        • Hospital Universitari Vall d´Hebrón
      • Barcelona, Spain
        • Fundacion Puigvert
      • Bilbao, Spain
        • Hospital de Basurto
      • Madrid, Spain
        • Hospital Doce de Octubre
      • Madrid, Spain
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain
        • Hospital Clinico Universitario S. Carlos
      • Majadahonda, Spain
        • Hospital Universitario Puerta de Hierro
      • Manacor, Spain
        • Hospital Manacor
      • Oviedo, Spain
        • Hospital Universitario Central de Asturias
      • Santiago de Compostela, Spain
        • Hospital Santiago de Compostela
      • Sevilla, Spain
        • Hospital Virgen Macarena
      • Valencia, Spain
        • Fundacion IVO
      • Vigo, Spain
        • Hospital Xeral de Vigo
  • Sweden
      • Göteborg, Sweden
        • Investigational Site
      • Göteborg, Sweden
        • SU/Sahlgrenska
      • Helsingborg, Sweden
        • Helsingborgs lasarett
      • Malmö, Sweden
        • Universitetssjukhuset MAS
      • Södertälje, Sweden
        • Södertälje Sjukhus
      • Uppsala, Sweden
        • Uppsala/Akademiska sjukhuset
  • Turkey
      • Ankara, Turkey
        • Ankara University Faculty of Medicine - Sıhhıye
      • Istanbul, Turkey
        • Cerrahpasa Faculty of Medicine - Kocamustafapasa
      • Istanbul, Turkey
        • Istanbul University Faculty of Medicine - ÇAPA
      • Istanbul, Turkey
        • Marmara University Faculty of Medicine - Altunizade

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Degarelix
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.
Drug: Degarelix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Time Frame: Up to 22.5 months
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.
Up to 22.5 months
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Time Frame: Up to 22.5 months
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.
Up to 22.5 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Levels of Prostate Specific Antigen (PSA)Over Time
Time Frame: from baseline to 72 weeks
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)
from baseline to 72 weeks
Serum Levels of Testosterone Over Time
Time Frame: from baseline to week 72
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)
from baseline to week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 18, 2009

First Submitted That Met QC Criteria

August 26, 2009

First Posted (Estimate)

August 27, 2009

Study Record Updates

Last Update Posted (Estimate)

January 3, 2013

Last Update Submitted That Met QC Criteria

January 2, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE200486 CS34
  • EudraCT No: 2008-006827-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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