Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

Stopped early · Phase 2

Conditions studied: Prostate Cancer

In brief

Participants responding well in Study FE200486 CS06 (NCT00117949) were given the opportunity to continue treatment with degarelix under a clinical study until FE200486 was available on the market or until the study was discontinued. Study FE200486 CS06A was to provide knowledge of the long-term safety and tolerability of FE200486.

Key facts

Study ID: NCT00117312
Run by: Ferring Pharmaceuticals
People needed: 37
Starts: 2002-10-01
Expected to finish: 2005-11-01
Last updated by the study team: 2011-05-23

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Any patient meeting any of the following exclusion criteria will not be entered into the study:
Has been withdrawn from Study FE200486 CS06 due to an adverse event, failure to achieve at least 28 days of testosterone suppression, insufficient prostate-specific antigen (PSA)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 procedures.
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 limits).
Has a mental incapacity or language barrier precluding adequate understanding or co-operation.

Where it is running

Advanced Urology Medical Center — Anaheim, California, United States
South Orange County Medical Research Center — Laguna Woods, California, United States
San Bernardino Urological Associates Medical Group — San Bernardino, California, United States
Western Clinical Research — Torrance, California, United States
Urology Associate PC' — Denver, Colorado, United States
SW Florida Urological Associates — Fort Myers, Florida, United States
Pinellas Urology, Inc. — St. Petersburg, Florida, United States
Drs. Werner, Murdock & Francis, PA — Greenbelt, Maryland, United States
Nevada Urology Associates — Reno, Nevada, United States
Urology Specialists of Oklahoma, Inc. — Tulsa, Oklahoma, United States
Urology Clinics of NorthTexas, PA — Dallas, Texas, United States
Urology San Antonio Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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