Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486
An Open-Label, Multi-Center, Ascending, Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486
1 other identifier
interventional
82
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 prostate-cancer
Started Apr 2002
Shorter than P25 for phase_2 prostate-cancer
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
July 11, 2005
CompletedResults Posted
Study results publicly available
June 5, 2009
CompletedMay 23, 2011
May 1, 2011
1.8 years
June 30, 2005
January 22, 2009
May 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time to Meet Insufficient Testosterone Response
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.
3 months
Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days
The number of participants suppressed for at least 28 days was defined as the estimated "survival probability" at time=Day 28.
28 days
Secondary Outcomes (5)
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL).
1, 3, 7, 14, 21, 28, 42 days
Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days
3 months
Time to 50% Reduction in Prostate-specific Antigen Levels
3 months
Time to 90% Reduction in Prostate-specific Antigen Levels
3 months
Liver Function Tests
3 months
Study Arms (4)
Degarelix 40 mg
EXPERIMENTALDegarelix 40 mg (10 mg/mL)
Degarelix 80 mg
EXPERIMENTALDegarelix 80 mg (20 mg/mL)
Degarelix 120 mg
EXPERIMENTALDegarelix 120 mg (30 mg/mL)
Degarelix 160 mg
EXPERIMENTALDegarelix 160 mg (40 mg/mL)
Interventions
One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Advanced Urology Medical Center
Anaheim, California, 92801, United States
South Orange County Medical Research Center
Laguna Woods, California, 92653, United States
San Bernardino Urological Associates Medical Group
San Bernardino, California, 92404, United States
Western Clinical Research
Torrance, California, 90505, United States
Urology Associate PC'
Denver, Colorado, 80210, United States
SW Florida Urological Associates
Fort Myers, Florida, 33907, United States
Pinellas Urology, Inc.
St. Petersburg, Florida, 33710, United States
Drs. Werner, Murdock & Francis, PA
Greenbelt, Maryland, 20770, United States
Nevada Urology Associates
Reno, Nevada, 89511, United States
Urology Specialists of Oklahoma, Inc.
Tulsa, Oklahoma, 74104, United States
Urology Clinics of NorthTexas, PA
Dallas, Texas, 75231, United States
Urology San Antonio Research
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Support
- Organization
- Ferring Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 11, 2005
Study Start
April 1, 2002
Primary Completion
January 1, 2004
Study Completion
January 1, 2004
Last Updated
May 23, 2011
Results First Posted
June 5, 2009
Record last verified: 2011-05