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 is to select a dose of a new trial drug (FE 200486). Three groups of patients will be treated for six months on different doses. The patients will have blood samples taken and measured for Testosterone in order to determine the most efficient dose to provide fast and sustained castration. The patients will come to the clinic for 16 visits and dependent on the blood sample results may be invited to return for additional blood samples on a two weekly basis.

Condition	Intervention	Phase
Prostate Cancer	Drug: FE 200486 Drug: FE200486	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:

Selection of a dosing regimen that will result in at least 70% patients with testosterone < 0.5 ng/ml after 1 week of initial dosing and at least 90% of patients with testosterone < 0.5 ng/ml in specific weeks thereafter. [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with testosterone < 0.5 ng/ml at all visits. [ Time Frame: Six months ] [ Designated as safety issue: No ]
Reduction of prostate specific antigen (PSA) compared to the value at the beginning of the trial. [ Time Frame: Six months ] [ Designated as safety issue: No ]
Evaluate the time course of testosterone, 5-α-dihydrotestosterone (DTH), luteinizing hormone (LH), follicle stimulating hormone (FSH) and PSA. [ Time Frame: Six months ] [ Designated as safety issue: No ]
Investigate the population pharmacokinetic and pharmacodynamic profile for testosterone and DTH. [ Time Frame: Six months ] [ Designated as safety issue: No ]
Evaluate the three dosing regimens with respect to safety and tolerability. [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
Estimate the proportion of patients meeting the withdrawal criteria for trial therapy with respect to testosterone and PSA. [ Time Frame: 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
1: Experimental	Drug: FE200486
2: Experimental	Drug: FE 200486
3: Experimental	Drug: FE 200486

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 preceeding 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

Responsible Party:	Ferring Pharmaceuticals ( Hjort, Director )
Study ID Numbers:	FE 200486 CS02
Study First Received:	January 7, 2009
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00819247
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

ClinicalTrials.gov processed this record on January 16, 2009