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

NCT ID: NCT00117312

Last Updated: 2011-05-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2005-11-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Degarelix 40 mg

Degarelix 40 mg (10 mg/mL)

Group Type: EXPERIMENTAL

Degarelix

Intervention Type: DRUG

One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.

Degarelix 80 mg

Degarelix 80 mg (20 mg/mL)

Group Type: EXPERIMENTAL

Degarelix

Intervention Type: DRUG

One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.

Degarelix 120 mg

Degarelix 120 mg (30 mg/mL)

Group Type: EXPERIMENTAL

Degarelix

Intervention Type: DRUG

One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.

Degarelix 160 mg

Degarelix 160 mg (40 mg/mL)

Group Type: EXPERIMENTAL

Degarelix

Intervention Type: DRUG

One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.

Interventions

Degarelix

One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.

Intervention Type: DRUG

Degarelix

One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.

Intervention Type: DRUG

Degarelix

One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.

Intervention Type: DRUG

Degarelix

One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.

Intervention Type: DRUG

Other Intervention Names

FE200486; FE200486; FE200486; FE200486

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Ferring Pharmaceuticals

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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

Countries

United States

Other Identifiers

FE200486 CS06A

Identifier Type: -

Identifier Source: org_study_id