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An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

The data include participants from both the main study (FE200486 CS06; NCT00117949) and the
extension study FE200486 CS06A.

Inclusion Criteria:

Each patient must meet the following inclusion criteria before entry into the study:

- Has given written consent before any study related activity is performed. A study
related activity is defined as any procedure that would not have been performed
during the normal management of the patient.

- Has had sufficient testosterone suppression (as defined in the withdrawal criteria of
FE200486 CS06) for at least 28 days.

Exclusion Criteria:

Any patient meeting any of the following exclusion criteria will not be entered into the

- Has been withdrawn from Study FE200486 CS06 due to an adverse event, failure to
achieve at least 28 days of testosterone suppression, insufficient prostate-specific
antigen (PSA) suppression as defined in Study FE200486 CS06 in the absence of
concomitant rise in testosterone level or non-compliance with protocol required

- Requires hormonal therapy for neoadjuvant purposes.

- Requires treatment with any other drug modifying the testosterone level or function.

- Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or
radiotherapy, within 6 months after Visit 1.

- Has a history of severe asthma requiring daily treatment with inhalation steroids,
angioedema or anaphylactic reactions.

- Has hypersensitivity towards any component of the investigational product.

- Has had a cancer disease within the last 10 years except for prostate cancer, and
surgically removed basocellular or squamous cell carcinoma of the skin.

- Has a clinically significant neurologic, gastrointestinal, renal, hepatic,
cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological,
dermatological or infectious disorder or any other condition, including excessive
alcohol or drug abuse, which may interfere with trial participation or which may
affect the conclusion of the study, as judged by the investigator.

- Any clinically significant laboratory abnormalities which, in the judgment of the
investigator, would interfere with the patient's participation in this study or
evaluation of study results (liver transaminases and bilirubin must be within normal

- Has a mental incapacity or language barrier precluding adequate understanding or

Type of Study:


Study Design:

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

Outcome Measure:

Liver Function Tests

Outcome Description:

The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals


United States: Food and Drug Administration

Study ID:

FE200486 CS06A



Start Date:

October 2002

Completion Date:

November 2005

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Androgen ablation therapy
  • Prostatic Neoplasms



Advanced Urology Medical Center Anaheim, California  92801
Urology San Antonio Research San Antonio, Texas  78229
Pinellas Urology, Inc. St. Petersburg, Florida  33710
South Orange County Medical Research Center Laguna Hills, California  92653
Nevada Urology Associates Reno, Nevada  89511
Western Clinical Research Torrance, California  90505
San Bernardino Urological Associates Medical Group San Bernardino, California  92404
SW Florida Urological Associates Fort Myers, Florida  33907
Urology Associate PC` Denver, Colorado  80210
Drs. Werner, Murdock & Francis, PA Greenbelt, Maryland  20770
Urology Specialists of Oklahoma, Inc. Tulsa, Oklahoma  74104
Urology Clinics of NorthTexas, PA Dallas, Texas  75231