Status:
TERMINATED
Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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 u...
Detailed Description
The data include participants from both the main study (FE200486 CS06; NCT00117949) and the extension study FE200486 CS06A.
Eligibility Criteria
Inclusion
- 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
- 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- Has been withdrawn from Study FE200486 CS06 due to an adverse event, failure to achieve at least 28 days of testosterone suppression, insufficient prostate-specific antigen (PSA)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.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00117312
Start Date
October 1 2002
End Date
November 1 2005
Last Update
May 23 2011
Active Locations (12)
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1
Advanced Urology Medical Center
Anaheim, California, United States, 92801
2
South Orange County Medical Research Center
Laguna Woods, California, United States, 92653
3
San Bernardino Urological Associates Medical Group
San Bernardino, California, United States, 92404
4
Western Clinical Research
Torrance, California, United States, 90505