Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients - Full Text View

Sponsored by:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00818623

Purpose

The purpose of this trial is to find an optimal dose for a new trial drug (FE200486) in the treatment of prostate cancer. Furthermore the safety will be studied and information on how the body handles the drug will be investigated. Patients participating will be treated with FE200486 on one occasion. Thereafter they will come in for visits following a specific schedule until blood samples shows that there is no further effect. The blood samples that will be analysed are for testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, sex hormone binding globulin and PSA. To measure the levels of the new drug in the body and the antibodies for the drug, samples for FE200486 and anti-FE200486 will also be analysed.

Condition	Intervention	Phase
Prostate Cancer	Drug: FE 200486	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Degarelix

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	An Open-Label, Multi-Center, Parallel and Sequential, Ascending Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486 in Prostate Cancer Patients

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

Evaluate the testosterone suppression. [ Time Frame: Two - six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the pharmacological effect on blood levels for 5-α-dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, and prostate specific antigen. [ Time Frame: Two - six months ] [ Designated as safety issue: No ]
Investigate population pharmacokinetics and pharmacodynamic relationship of ascending doses for description of the testosterone suppression. [ Time Frame: Two - six months ] [ Designated as safety issue: No ]
Evaluate the safety and tolerability of ascending single doses. [ Time Frame: Two - six months ] [ Designated as safety issue: Yes ]
Investigate the level of antibody formation. [ Time Frame: Two - six months ] [ Designated as safety issue: No ]
Investigate population pharmacokinetics. [ Time Frame: Two - six months ] [ Designated as safety issue: No ]

Enrollment:	180
Study Start Date:	November 2002
Study Completion Date:	November 2004
Primary Completion Date:	October 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: 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:

Written informed consent obtained before any trial related procedures
Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy
ECOG score to be equal to or above 2
Testosterone level within age-specific normal range
PSA value equal to or above 2 ng/ml
Life expectancy of at least 6 months

Exclusion Criteria:

Previous or current hormonal treatment of prostate cancer
Recent or current treatment with any drugs modifying the testosterone level
Candidate for curative treatment such as 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
Signs of liver impairment shown as elevated serum ALT or serum bilirubin
Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
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: NCT00818623

Locations

Denmark
Rigshospitalet
Copenhagen, Denmark
KAS Herlev
Herlev, Denmark
KAS Glostrup
Glostrup, Denmark
Finland
P-K Keskussairaala
Joensuu, Finland
OYS
Oulu, Finland
Marian Sairaala
Helsinki, Finland
TAYS
Tampere, Finland
Vuorikadun lääkäriasema
Kuopio, Finland
Kirugikeskus
Seinäjoki, Finland
Hungary
Jahn Ferenc Dél Pesti Hospital, Urology
Budapest, Hungary
Péterfy Hospital, Urology
Budapest, Hungary
Bács-Kiskun County Hospital, Urology
Kecskemét, Hungary
Hospital of Local Gov. Szeged, Urology
Szeged, Hungary
MÁV Hospital, Urology
Szolnok, Hungary
Bajcsy-Zsilinszky Hospital, Urology
Budapest, Hungary
Norway
Sentralsykehuset i Rogland
Stavanger, Norway
Romania
Dr. Th Burghele Hospital
Bucharest, Romania
CF2 Hospital - Bucharest, Urology
Bucharest, Romania
Fundeni Hospital - Bucharest, Urology
Bucharest, Romania
County Hospital - Timisoara, Urology
Timisoara, Romania
Russian Federation
City Hospital #15, Urology Department
St. Petersburg, Russian Federation
City Hospital #26, Urology Department
St. Petersburg, Russian Federation
City Hospital #1, State Med Univ/Urology
Moscow, Russian Federation
Moscow City Hospital #60, Urology
Moscow, Russian Federation
Institute of Urology of MoH
Moscow, Russian Federation
Sweden
Universitetssjukehuset, MAS
Malmö, Sweden
University Hospital, Örebro
Örebro, Sweden
Helsingborgs Lasaret
Helsingborg, Sweden
Akademiska Sjukhuset Uppsala
Uppsala, Sweden
Sahlgrenska Universitetssjukehuset
Göteborg, Sweden

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 CS07
Study First Received:	January 7, 2009
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00818623
Health Authority:	Denmark: Danish Medicines Agency; Denmark: Ethics Committee; Finland: National Agency for Medicines; Finland: Ethics Committee; Norway: Norwegian Medicines Agency; Norway: The National Committees for Research Ethics in Norway; Sweden: Medical Products Agency; Sweden: Swedish National Council on Medical Ethics; Romania: National Medicines Agency; Romania: Ministry of Public Health; Hungary: National Institute of Pharmacy; Russia: FSI Scientific Center of Expertise of Medical Application; Russia: Ministry of Health and Social Development of the Russian Federation; Russia: 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