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Trial record 1 of 2 for:    degarelix AND CS06
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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
History of Changes
Results First Received: January 22, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: Degarelix

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants who responded to degarelix in FE200486 CS06 (NCT00117949) were eligible to enroll into this extension study with the intention of continuing treatment until degarelix became commercially available in the US or until the study was discontinued. Participants received the same dose of degarelix as they received in FE200486 CS06.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Degarelix 40 mg Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg Degarelix 160 mg (40 mg/mL)

Participant Flow:   Overall Study
    Degarelix 40 mg   Degarelix 80 mg   Degarelix 120 mg   Degarelix 160 mg
STARTED   10   24   24   24 
Started FE200486 CS06A   1   11   16   9 
COMPLETED   0   4 [1]   0   3 
NOT COMPLETED   10   20   24   21 
Testosterone >1.0 ng/mL                9                9                5                9 
Testosterone 0.5 - 1.0 ng/mL                1                0                3                2 
Prostate-specific antigen increase >=25%                0                1                5                3 
Not specified                0                1                3                1 
Patient choice                0                0                2                1 
Adverse Event                0                2                0                0 
Protocol Violation                0                1                3                0 
PSA decrease <=50%                0                2                2                4 
PSA increase >= 10ng/mL                0                1                1                0 
Hepatic abnormality                0                1                0                1 
Withdrawal by Subject                0                2                0                0 
[1] Defined as those patients ongoing when the extension study was terminated



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Degarelix 40 mg Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg Degarelix 160 mg (40 mg/mL)
Total Total of all reporting groups

Baseline Measures
   Degarelix 40 mg   Degarelix 80 mg   Degarelix 120 mg   Degarelix 160 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 10   24   24   24   82 
Age 
[Units: Participants]
 		         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   1   1   2   4   8 
>=65 years   9   23   22   20   74 
Age 
[Units: Years]
Mean (Standard Deviation) 		 72.0  (5.72)   77.5  (6.38)   75.9  (5.79)   74.7  (8.37)   75.6  (6.90) 
Gender 
[Units: Participants]
 		         
Female   0   0   0   0   0 
Male   10   24   24   24   82 
Race/Ethnicity, Customized 
[Units: Participants]
 		         
Black   2   1   2   1   6 
Caucasian   5   23   15   20   63 
Other   3   0   7   3   13 
Gleason score [1] 
[Units: Participants]
 		         
Unknown   0   1   0   0   1 
2-4   1   1   1   0   3 
5-6   3   14   12   13   42 
7-10   6   8   11   11   36 
[1] The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive.
Stage of prostate cancer [1] 
[Units: Participants]
 		         
Localized   5   11   12   10   38 
Locally advanced   0   6   5   5   16 
Metastatic   2   4   2   2   10 
Not classifiable   3   3   5   7   18 
[1] Prostate cancer stage was classified to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor.
Body mass index [1] 
[Units: Kilogram per square meter]
Mean (Standard Deviation) 		 26.7  (5.66)   26.6  (3.54)   27.2  (3.15)   26.6  (3.39)   26.8  (3.64) 
[1] Body mass is a measure of body fat based on height and weight.
Time since prostate cancer diagnosis [1] 
[Units: Days]
Mean (Standard Deviation) 		 851  (1077)   954  (1329)   1609  (1836)   1095  (1385)   1181  (1494) 
[1] Mean number of days since the participants in each treatment were diagnosed with prostate cancer.
Weight 
[Units: Kilogram]
Mean (Standard Deviation) 		 79.0  (11.7)   81.7  (11.5)   80.8  (12.8)   81.4  (14.4)   81.0  (12.6) 


  Outcome Measures
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1.  Primary:   Liver Function Tests   [ Time Frame: 3 years ]

Measure Type Primary
Measure Title Liver Function Tests
Measure Description 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.
Time Frame 3 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The data include patients from both the main study (FE200486 CS06) and the extension study FE200486 CS06A.

Reporting Groups
  Description
Degarelix 40 mg Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg Degarelix 160 mg (40 mg/mL)

Measured Values
   Degarelix 40 mg   Degarelix 80 mg   Degarelix 120 mg   Degarelix 160 mg 
Participants Analyzed 
[Units: Participants]
 		 10   24   24   24 
Liver Function Tests 
[Units: Participants]
 		       
Abnormal alanine aminotransferase (ALAT)   0   4   5   6 
Abnormal aspartate aminotransferase   1   13   18   9 
Abnormal bilirubin   2   0   4   2 
ALAT >3x ULN   0   1   0   0 
ALAT >3x ULN, bilirubin >1.5x ULN   0   0   0   0 

No statistical analysis provided for Liver Function Tests



2.  Primary:   Participants With Markedly Abnormal Change in Vital Signs and Body Weight   [ Time Frame: 3 years ]

Measure Type Primary
Measure Title Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Measure Description 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.
Time Frame 3 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
These data include patients from the main study (FE200486 CS06) and the extension study (FE200486 CS06A).

Reporting Groups
  Description
Degarelix 40 mg Degarelix 40 mg (10 mg/mL)
Degarelix 80 mg Degarelix 80 mg (20 mg/mL)
Degarelix 120 mg Degarelix 120 mg (30 mg/mL)
Degarelix 160 mg Degarelix 160 mg (40 mg/mL)

Measured Values
   Degarelix 40 mg   Degarelix 80 mg   Degarelix 120 mg   Degarelix 160 mg 
Participants Analyzed 
[Units: Participants]
 		 10   24   24   24 
Participants With Markedly Abnormal Change in Vital Signs and Body Weight 
[Units: Participants]
 		       
Diastolic blood pressure <=50 and decrease >=15   0   1   2   0 
Diastolic blood pressure >=105 and increase >=15   0   0   0   0 
Systolic blood pressure <=90 and decrease >=20   0   3   0   1 
Systolic blood pressure >=180 and increase >=20   0   0   1   0 
Heart rate <=50 and decrease >=15   0   1   2   3 
Heart rate >=120 and increase >=15   0   0   0   0 
Body weight decrease of >=7 percent   0   0   1   0 
Body weight increase of >=7 percent   0   1   6   1 

No statistical analysis provided for Participants With Markedly Abnormal Change in Vital Signs and Body Weight




  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Ferring Pharmaceuticals
Organization: Clinical Development Support
e-mail: DK0-Disclosure@ferring.com



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