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

Phase 2

Terminated

• Conditions: Prostate Cancer
• Interventions: Drug: Degarelix

• Registration Number: NCT00117312
• Lead Sponsor: Ferring Pharmaceuticals

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 until the study was discontinued.

Study FE200486 CS06A was to provide knowledge of the long-term safety and tolerability of FE200486.

Detailed Description

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

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-06
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Results First Submitted: 2009-01-22
• Results First Submitted QC: 2009-03-19
• Results First Posted: 2009-03-20
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-18
• Last Update Posted: 2011-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 37

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.

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Exclusion Criteria

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• Has been withdrawn from Study FE200486 CS06 due to an adverse event, failure to achieve at least 28 days of testosterone suppression, insufficient prostate-specific antigen (PSA)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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Degarelix 80 mg	Degarelix	Degarelix 80 mg (20 mg/mL)
Degarelix 40 mg	Degarelix	Degarelix 40 mg (10 mg/mL)
Degarelix 120 mg	Degarelix	Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg	Degarelix	Degarelix 160 mg (40 mg/mL)

Primary Outcome Measures

Name	Time	Method
Liver Function Tests	3 years	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.
Participants With Markedly Abnormal Change in Vital Signs and Body Weight	3 years	Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.

Trial Locations

Locations (12)

Urology San Antonio Research; 🇺🇸 San Antonio, Texas, United States

South Orange County Medical Research Center; 🇺🇸 Laguna Woods,, California, United States

Western Clinical Research; 🇺🇸 Torrance, California, United States

Advanced Urology Medical Center; 🇺🇸 Anaheim, California, United States

Drs. Werner, Murdock & Francis, PA; 🇺🇸 Greenbelt, Maryland, United States

Urology Specialists of Oklahoma, Inc.; 🇺🇸 Tulsa, Oklahoma, United States

SW Florida Urological Associates; 🇺🇸 Fort Myers, Florida, United States

San Bernardino Urological Associates Medical Group; 🇺🇸 San Bernardino, California, United States

Nevada Urology Associates; 🇺🇸 Reno, Nevada, United States

Pinellas Urology, Inc.; 🇺🇸 St. Petersburg, Florida, United States

Urology Clinics of NorthTexas, PA; 🇺🇸 Dallas, Texas, United States

Urology Associate PC'; 🇺🇸 Denver, Colorado, United States