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Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00117949
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : June 5, 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 11, 2005
Results First Submitted Date  ICMJE January 22, 2009
Results First Posted Date  ICMJE June 5, 2009
Last Update Posted Date May 23, 2011
Study Start Date  ICMJE April 2002
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2011)
  • Time to Meet Insufficient Testosterone Response [ Time Frame: 3 months ]
    Figures in the table are Kaplan-Meier estimates of the time to meeting insufficient testosterone response. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.
  • Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days [ Time Frame: 28 days ]
    The number of participants suppressed for at least 28 days was defined as the estimated "survival probability" at time=Day 28.
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2005)
To investigate the pharmacological effects of ascending single doses of FE200486 administered subcutaneously to prostate cancer patients in terms of testosterone suppression.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2011)
  • Time to Testosterone Castration (Testosterone ≤0.5 ng/mL). [ Time Frame: 1, 3, 7, 14, 21, 28, 42 days ]
    Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL. The figures in the table present the number of participants who were castrated after 1, 3, 7, 14, 21, 28, and 42 days.
  • Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days [ Time Frame: 3 months ]
    Sufficient testosterone suppression was defined as not meeting an insufficient testosterone response criterion. Insufficient testosterone response was defined as testosterone >1.0 ng/mL at one visit or testosterone 0.5-1.0 at two consecutive visits.
  • Time to 50% Reduction in Prostate-specific Antigen Levels [ Time Frame: 3 months ]
    The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 50% reduction in PSA level was reached.
  • Time to 90% Reduction in Prostate-specific Antigen Levels [ Time Frame: 3 months ]
    The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the median number of days from dosing to the first visit where a 90% reduction in PSA level was reached.
  • Liver Function Tests [ Time Frame: 3 months ]
    The number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferas 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2005)
  • To investigate the population pharmacokinetic and pharmacodynamic relationship of escalating single doses of FE200486, and thus describe the single dose concentration-response curve for testosterone suppression.
  • To evaluate the safety and tolerability of ascending single doses of FE200486
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486
Official Title  ICMJE An Open-Label, Multi-Center, Ascending, Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486
Brief Summary Population pharmacokinetic and pharmacodynamic data from Study FE200486 CS06 and FE200486 CS02 provided further knowledge of the optimal dose regimens for FE200486 (degarelix). Both studies were to guide dose selection for phase III. In addition, safety and tolerance data were generated.
Detailed Description Not Provided
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 Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2009)
82
Original Enrollment  ICMJE
 (submitted: June 30, 2005)
83
Actual Study Completion Date  ICMJE January 2004
Actual Primary Completion Date January 2004   (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.)
  • Is a male patient with histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment is indicated, except for neoadjuvant hormonal therapy. For patients, prostate-specific antigen (PSA) increases on two consecutive determinations at least 2 weeks apart prior to Visit 1 must be documented.
  • Is at least 18 years.
  • Has an ECOG score of 2.
  • Has a baseline testosterone level within the age specific normal range as measured by the central laboratory.
  • Has a PSA value of 2 ng/mL as measured by the central laboratory.
  • Has a life expectancy of at least 6 months.

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be entered into the study:

  • Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, estrogens, PC-Spec) except for neoadjuvant hormonal therapy of < 6 months duration and completed > 6 months prior to Visit 1.
  • Requires hormonal therapy for neoadjuvant purposes.
  • Is recently (within the last 12 weeks preceding Visit 1) or presently treated 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 must be within normal limits).
  • Has a mental incapacity or language barrier precluding adequate understanding or co-operation.
  • Has received an investigational drug within the last 12 weeks preceding Visit 1.
  • Has previously participated in this study.
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 NCT00117949
Other Study ID Numbers  ICMJE FE200486 CS06
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