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

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ClinicalTrials.gov Identifier: NCT00117312
Recruitment Status : Terminated (After 190 weeks [7 patients left] it was terminated for administrative reasons)
First Posted : July 6, 2005
Results First Posted : March 20, 2009
Last Update Posted : May 23, 2011
Sponsor:
Information provided by:
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 30, 2005
First Posted Date  ICMJE July 6, 2005
Results First Submitted Date  ICMJE January 22, 2009
Results First Posted Date  ICMJE March 20, 2009
Last Update Posted Date May 23, 2011
Study Start Date  ICMJE October 2002
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2011)
  • Liver Function Tests [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2005)
To investigate the long-term safety and tolerability after repeat doses of FE200486 in prostate cancer patients
Change History Complete list of historical versions of study NCT00117312 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2005)
To investigate the long-term response with respect to testosterone suppression after repeat doses of FE200486 in prostate cancer patients
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Official Title  ICMJE An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Degarelix
    One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.
    Other Name: FE200486
  • Drug: Degarelix
    One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.
    Other Name: FE200486
  • Drug: Degarelix
    One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.
    Other Name: FE200486
  • Drug: Degarelix
    One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.
    Other Name: FE200486
Study Arms  ICMJE
  • Experimental: Degarelix 40 mg
    Degarelix 40 mg (10 mg/mL)
    Intervention: Drug: Degarelix
  • Experimental: Degarelix 80 mg
    Degarelix 80 mg (20 mg/mL)
    Intervention: Drug: Degarelix
  • Experimental: Degarelix 120 mg
    Degarelix 120 mg (30 mg/mL)
    Intervention: Drug: Degarelix
  • Experimental: Degarelix 160 mg
    Degarelix 160 mg (40 mg/mL)
    Intervention: Drug: Degarelix
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 30, 2005)
37
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00117312
Other Study ID Numbers  ICMJE FE200486 CS06A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinical Development Support, Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Development Support Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP