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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00117312
• Other study ID #: FE200486 CS06A
• Status: Terminated
• Phase: Phase 2
• First received: June 30, 2005
• Last updated: May 18, 2011
• Start date: October 2002
• Est. completion date: November 2005

Study information

• Verified date: May 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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• Has been withdrawn from Study FE200486 CS06 due to an adverse event, failure to achieve at least 28 days of testosterone suppression, insufficient prostate-specific antigen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

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.
• Degarelix
One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.
• Degarelix
One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.
• Degarelix
One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver Function Tests	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.	3 years	No
Primary	Participants With Markedly Abnormal Change in Vital Signs and Body Weight	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.	3 years	No