The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer - Full Text View

Sponsored by:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00819247

Purpose

The purpose of this trial was to select a dose of degarelix (FE 200486). Three groups of patients were treated for six months on different doses. The patients had blood samples taken and measured for Testosterone in order to determine the most efficient dose to provide fast and sustained castration.

The patients came to the clinic for 16 visits and dependent on the blood sample results they were invited to return for additional blood samples on a two weekly basis.

Condition	Intervention	Phase
Prostate Cancer	Drug: Degarelix	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Degarelix

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Six Month, Multi-Centre, Open-Labelled, 1:1:1 Randomised, Parallel Group Study Investigating the Efficacy and Safety of Three Dose Regimens of FE 200486 in Prostate Cancer Patients

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

Number of Participants With Testosterone <0.5 Nanogram/Milliliter [ Time Frame: Weeks 1,2,4,8,12,16,20,24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24 [ Time Frame: Weeks 4-24 ] [ Designated as safety issue: No ]
Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24 [ Time Frame: Weeks 4-24 ] [ Designated as safety issue: No ]
Number of Participants Who Met the Withdrawl Criteria for Prostate-Specific Antigen [ Time Frame: Six months ] [ Designated as safety issue: No ]
Number of Participants With Normal Prostate-Specific Antigen Levels During the Study [ Time Frame: Weeks 12, 24 ] [ Designated as safety issue: No ]
The Number of Participants With Abnormal Liver Function Tests [ Time Frame: Six months ] [ Designated as safety issue: No ]
Percentage Change in Vital Signs and Body Weight [ Time Frame: Baseline and Six months ] [ Designated as safety issue: No ]

Enrollment:	129
Study Start Date:	March 2001
Study Completion Date:	August 2002
Primary Completion Date:	May 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Degarelix 80/80 + 40: Experimental Loading doses of Degarelix 80 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140.	Drug: Degarelix Given as a subcutaneous injection.
Degarelix 40/40 + 40: Experimental Loading doses of Degarelix 40 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140.	Drug: Degarelix Given as a subcutaneous injection.
Degarelix 80 + 20: Experimental Loading dose of Degarelix 80 mg (20 mg/mL) on Day 0. Maintenance doses of 20 mg (10 mg/mL) given on days 28, 56, 84, 112 and 140.	Drug: Degarelix Given as a subcutaneous injection.

Detailed Description:

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed informed consent before any trial related activity
Proven prostate cancer with a need for endocrine treatment
Testosterone level within the normal range for the age

Exclusion Criteria:

Previous or current hormonal treatment of prostate cancer
Candidate for prostatectomy or radiotherapy
History of severe asthma, anaphylactic reactions or Quincke's Oedema
Hypersensitivity towards any component of FE200486
Cancer disease within the last ten years except for prostate cancer and some skin cancers
Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
Mental incapacity or language barrier
Having received an investigational product within the last 12 weeks preceding the trial
Previous participation in this trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819247

Locations

United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Southmead Hospital
Bristol, United Kingdom
St. Richards Hospital
Chichester, United Kingdom
St. Bartholemews Hospital
London, United Kingdom
Lister Hospital
Stevenage, United Kingdom
Leicester General Hospital
Leicester, United Kingdom
Morriston Hospital
Swansea, United Kingdom
Pindersfields General Hospital
Wakefield, United Kingdom
Kings College Hospital
London, United Kingdom
Southern General Hospital
Glasgow, United Kingdom
Ayr Hospital
Ayr, United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom
Glan Clwyd Hospital
Denbighshire, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
Stirling Royal Infirmary
Stirling, United Kingdom
Ninewells Hospital
Dundee, United Kingdom

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

No publications provided

Responsible Party:	Ferring Pharmaceuticals ( Hjort, Director )
Study ID Numbers:	FE200486 CS02
Study First Received:	January 7, 2009
Results First Received:	January 22, 2009
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00819247 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009