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

This study has been terminated.
(After 190 weeks [7 patients left] it was terminated for administrative reasons)
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00117312
First received: June 30, 2005
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Liver Function Tests [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 37
Study Start Date: October 2002
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Degarelix 40 mg
Degarelix 40 mg (10 mg/mL)
Drug: Degarelix
One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.
Other Name: FE200486
Experimental: Degarelix 80 mg
Degarelix 80 mg (20 mg/mL)
Drug: Degarelix
One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.
Other Name: FE200486
Experimental: Degarelix 120 mg
Degarelix 120 mg (30 mg/mL)
Drug: Degarelix
One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.
Other Name: FE200486
Experimental: Degarelix 160 mg
Degarelix 160 mg (40 mg/mL)
Drug: Degarelix
One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.
Other Name: FE200486

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117312

Locations
United States, California
Advanced Urology Medical Center
Anaheim, California, United States, 92801
South Orange County Medical Research Center
Laguna Woods,, California, United States, 92653
San Bernardino Urological Associates Medical Group
San Bernardino, California, United States, 92404
Western Clinical Research
Torrance, California, United States, 90505
United States, Colorado
Urology Associate PC`
Denver, Colorado, United States, 80210
United States, Florida
SW Florida Urological Associates
Fort Myers, Florida, United States, 33907
Pinellas Urology, Inc.
St. Petersburg, Florida, United States, 33710
United States, Maryland
Drs. Werner, Murdock & Francis, PA
Greenbelt, Maryland, United States, 20770
United States, Nevada
Nevada Urology Associates
Reno, Nevada, United States, 89511
United States, Oklahoma
Urology Specialists of Oklahoma, Inc.
Tulsa, Oklahoma, United States, 74104
United States, Texas
Urology Clinics of NorthTexas, PA
Dallas, Texas, United States, 75231
Urology San Antonio Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00117312     History of Changes
Other Study ID Numbers: FE200486 CS06A
Study First Received: June 30, 2005
Results First Received: January 22, 2009
Last Updated: May 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:
Prostate Cancer
Androgen ablation therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 26, 2014