Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
May 18, 2011 updated by: Ferring Pharmaceuticals
An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention (FDA regulated intervention is therefore ticked "YES").
The data include participants from both the main study (FE200486 CS07; NCT00818623) and the extension study FE200486 CS07A.
Study Type
Interventional
Enrollment (Actual)
131
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Males aged 18 or over
- Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy)
- Has completed Study FE200486 CS07
- Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Degarelix 120 mg (20 mg/mL)
|
Degarelix 120 mg (20 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 120 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 160 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 200 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 200 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 240 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 240 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 320 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
|
|
Experimental: Degarelix 120 mg (40 mg/mL)
|
Degarelix 120 mg (20 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 120 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 160 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 200 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 200 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 240 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 240 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 320 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
|
|
Experimental: Degarelix 160 mg (40 mg/mL)
|
Degarelix 120 mg (20 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 120 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 160 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 200 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 200 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 240 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 240 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 320 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
|
|
Experimental: Degarelix 200 mg (40 mg/mL)
|
Degarelix 120 mg (20 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 120 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 160 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 200 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 200 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 240 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 240 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 320 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
|
|
Experimental: Degarelix 200 mg (60 mg/mL)
|
Degarelix 120 mg (20 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 120 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 160 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 200 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 200 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 240 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 240 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 320 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
|
|
Experimental: Degarelix 240 mg (40 mg/mL)
|
Degarelix 120 mg (20 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 120 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 160 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 200 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 200 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 240 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 240 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 320 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
|
|
Experimental: Degarelix 240 mg (60 mg/mL)
|
Degarelix 120 mg (20 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 120 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 160 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 200 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 200 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 240 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 240 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 320 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
|
|
Experimental: Degarelix 320 mg (60 mg/mL)
|
Degarelix 120 mg (20 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 120 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 160 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 200 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 200 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 240 mg (40 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 240 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
Degarelix 320 mg (60 mg/mL).
Participants received same dose as in main study (FE200486 CS07; NCT00818623).
Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 years
|
|
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 patients in each group with normal baseline and markedly abnormal value post-baseline.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Primary Completion (Actual)
March 1, 2006
Study Completion (Actual)
March 1, 2006
Study Registration Dates
First Submitted
September 20, 2005
First Submitted That Met QC Criteria
September 20, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
May 20, 2011
Last Update Submitted That Met QC Criteria
May 18, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FE200486 CS07A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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