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An Open-Label, Multi-Center, Parallel and Sequential, Ascending Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486 in Prostate Cancer Patients


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

An Open-Label, Multi-Center, Parallel and Sequential, Ascending Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486 in Prostate Cancer Patients


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time From Dosing Until Testosterone Levels >0.5 ng/mL

Outcome Description:

Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value >0.5 ng/mL at Day 28 onwards.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals

Authority:

Denmark: Danish Medicines Agency

Study ID:

FE200486 CS07

NCT ID:

NCT00818623

Start Date:

November 2002

Completion Date:

October 2004

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

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