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Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients

NCT ID: NCT00818623

Last Updated: 2023-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2004-10-31

Brief Summary

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The purpose of this trial was to find an optimal dose for a new trial drug - degarelix (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was studied. Patients participating were treated with FE200486 on one occasion. Thereafter they came in for visits following a specific schedule until blood samples showed that there was no further effect.

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Degarelix 120 mg (20 mg/mL)

Degarelix 120 mg (20 mg/mL)

Group Type EXPERIMENTAL

Degarelix

Intervention Type DRUG

Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection

Degarelix 120 mg (40 mg/mL)

Degarelix 120 mg (40 mg/mL)

Group Type EXPERIMENTAL

Degarelix

Intervention Type DRUG

Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection

Degarelix 160 mg (40 mg/mL)

Degarelix 160 mg (40 mg/mL)

Group Type EXPERIMENTAL

Degarelix

Intervention Type DRUG

Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection

Degarelix 200 mg (40 mg/mL)

Degarelix 200 mg (40 mg/mL)

Group Type EXPERIMENTAL

Degarelix

Intervention Type DRUG

Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection

Degarelix 200 mg (60 mg/mL)

Degarelix 200 mg (60 mg/mL)

Group Type EXPERIMENTAL

Degarelix

Intervention Type DRUG

Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection

Degarelix 240 mg (40 mg/mL)

Degarelix 240 mg (40 mg/mL)

Group Type EXPERIMENTAL

Degarelix

Intervention Type DRUG

Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection

Degarelix 240 mg (60 mg/mL)

Degarelix 240 mg (60 mg/mL)

Group Type EXPERIMENTAL

Degarelix

Intervention Type DRUG

Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection

Degarelix 320 mg (60 mg/mL)

Degarelix 320 mg (60 mg/mL)

Group Type EXPERIMENTAL

Degarelix

Intervention Type DRUG

Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection

Interventions

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Degarelix

Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection

Intervention Type DRUG

Degarelix

Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection

Intervention Type DRUG

Degarelix

Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection

Intervention Type DRUG

Degarelix

Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection

Intervention Type DRUG

Degarelix

Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection

Intervention Type DRUG

Degarelix

Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection

Intervention Type DRUG

Degarelix

Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection

Intervention Type DRUG

Degarelix

Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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FE200486 FE200486 FE200486 FE200486 FE200486 FE200486 FE200486 FE200486

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Ferring Pharmaceuticals

Principal Investigators

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Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

KAS Glostrup

Glostrup Municipality, , Denmark

Site Status

KAS Herlev

Herlev, , Denmark

Site Status

Marian Sairaala

Helsinki, , Finland

Site Status

P-K Keskussairaala

Joensuu, , Finland

Site Status

Vuorikadun lääkäriasema

Kuopio, , Finland

Site Status

OYS

Oulu, , Finland

Site Status

Kirugikeskus

Seinäjoki, , Finland

Site Status

TAYS

Tampere, , Finland

Site Status

Bajcsy-Zsilinszky Hospital, Urology

Budapest, , Hungary

Site Status

Jahn Ferenc Dél Pesti Hospital, Urology

Budapest, , Hungary

Site Status

Péterfy Hospital, Urology

Budapest, , Hungary

Site Status

Bács-Kiskun County Hospital, Urology

Kecskemét, , Hungary

Site Status

Hospital of Local Gov. Szeged, Urology

Szeged, , Hungary

Site Status

MÁV Hospital, Urology

Szolnok, , Hungary

Site Status

Sentralsykehuset i Rogland

Stavanger, , Norway

Site Status

CF2 Hospital - Bucharest, Urology

Bucharest, , Romania

Site Status

Dr. Th Burghele Hospital

Bucharest, , Romania

Site Status

Fundeni Hospital - Bucharest, Urology

Bucharest, , Romania

Site Status

County Hospital - Timisoara, Urology

Timișoara, , Romania

Site Status

City Hospital #1, State Med Univ/Urology

Moscow, , Russia

Site Status

Institute of Urology of MoH

Moscow, , Russia

Site Status

Moscow City Hospital #60, Urology

Moscow, , Russia

Site Status

City Hospital #15, Urology Department

Saint Petersburg, , Russia

Site Status

City Hospital #26, Urology Department

Saint Petersburg, , Russia

Site Status

Sahlgrenska Universitetssjukehuset

Gothenburg, , Sweden

Site Status

Helsingborgs Lasaret

Helsingborg, , Sweden

Site Status

Universitetssjukehuset, MAS

Malmo, , Sweden

Site Status

University Hospital, Örebro

Örebro, , Sweden

Site Status

Akademiska Sjukhuset Uppsala

Uppsala, , Sweden

Site Status

Countries

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Denmark Finland Hungary Norway Romania Russia Sweden

Other Identifiers

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FE200486 CS07

Identifier Type: -

Identifier Source: org_study_id