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

This study has been terminated.
(The doses were not effective in maintaining testosterone suppression)
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00215657
First received: September 20, 2005
Last updated: May 18, 2011
Last verified: May 2011
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 CS07 (NCT00818623) were eligible to enroll into this extension study with the intention of continuing treatment until degarelix became commercially available or until the study was discontinued. Participants received the same dose of degarelix as they received in FE200486 CS07.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
180 participants started the main study CS07 and 172 participants received degarelix treatment (intention-to-treat population). Of these, 131 participants were recruited into the extension study CS07A

Reporting Groups
  Description
Degarelix 120mg (20mg/mL) Degarelix 120 mg (20 mg/mL)
Degarelix 120mg (40mg/mL) Degarelix 120 mg (40 mg/mL)
Degarelix 160mg (40mg/mL) Degarelix 160 mg (40 mg/mL)
Degarelix 200mg (40mg/mL) Degarelix 200 mg (40 mg/mL)
Degarelix 200mg (60mg/mL) Degarelix 200 mg (60 mg/mL)
Degarelix 240mg (40mg/mL) Degarelix 240 mg (40 mg/mL)
Degarelix 240mg (60mg/mL) Degarelix 240 mg (60 mg/mL)
Degarelix 320mg (60mg/mL) Degarelix 320 mg (60 mg/mL)

Participant Flow:   Overall Study
    Degarelix 120mg (20mg/mL)     Degarelix 120mg (40mg/mL)     Degarelix 160mg (40mg/mL)     Degarelix 200mg (40mg/mL)     Degarelix 200mg (60mg/mL)     Degarelix 240mg (40mg/mL)     Degarelix 240mg (60mg/mL)     Degarelix 320mg (60mg/mL)  
STARTED     26     12     13     24     27     24     27     27  
Intention-to-treat Population     25     12     12     24     24     24     24     27  
Started FE200486 CS07A     20     6     7     24     17     20     14     23  
COMPLETED     4 [1]   1     2     6     4     4     4     11  
NOT COMPLETED     22     11     11     18     23     20     23     16  
Adverse Event                 5                 1                 3                 0                 3                 1                 0                 3  
Withdrawal by Subject                 6                 3                 3                 1                 6                 1                 10                 3  
Insuff prostate specific antigen resp                 3                 2                 2                 2                 1                 2                 3                 2  
Insufficient testosterone response                 5                 4                 1                 12                 8                 12                 4                 7  
Not specified                 3                 1                 2                 3                 5                 4                 6                 1  
[1] Participants ongoing at the time of study closure were considered to have completed the study.



  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 120mg (20mg/mL) Degarelix 120 mg (20 mg/mL)
Degarelix 120mg (40mg/mL) Degarelix 120 mg (40 mg/mL)
Degarelix 160mg (40mg/mL) Degarelix 160 mg (40 mg/mL)
Degarelix 200mg (40mg/mL) Degarelix 200 mg (40 mg/mL)
Degarelix 200mg (60mg/mL) Degarelix 200 mg (60 mg/mL)
Degarelix 240mg (40mg/mL) Degarelix 240 mg (40 mg/mL)
Degarelix 240mg (60mg/mL) Degarelix 240 mg (60 mg/mL)
Degarelix 320mg (60mg/mL) Degarelix 320 mg (60 mg/mL)
Total Total of all reporting groups

Baseline Measures
    Degarelix 120mg (20mg/mL)     Degarelix 120mg (40mg/mL)     Degarelix 160mg (40mg/mL)     Degarelix 200mg (40mg/mL)     Degarelix 200mg (60mg/mL)     Degarelix 240mg (40mg/mL)     Degarelix 240mg (60mg/mL)     Degarelix 320mg (60mg/mL)     Total  
Number of Participants  
[units: participants]
  25     12     12     24     24     24     24     27     172  
Age [1]
[units: participants]
                 
<=18 years     0     0     0     0     0     0     0     0     0  
Between 18 and 65 years     7     0     2     2     4     2     6     6     29  
>=65 years     18     12     10     22     20     22     18     21     143  
Age [2]
[units: years]
Mean ± Standard Deviation
  70.0  ± 10.3     73.8  ± 3.97     70.1  ± 8.08     74.3  ± 6.48     71.5  ± 8.27     73.1  ± 5.96     71.7  ± 9.54     71.1  ± 6.87     71.9  ± 7.83  
Gender [2]
[units: participants]
                 
Female     0     0     0     0     0     0     0     0     0  
Male     25     12     12     24     24     24     24     27     172  
Race/Ethnicity, Customized [2]
[units: participants]
                 
Caucasian     25     12     12     24     24     24     24     27     172  
Curative intent [3]
[units: participants]
                 
Yes     0     0     2     3     1     0     0     1     7  
No     25     12     10     21     23     24     24     26     165  
Gleason score [4]
[units: participants]
                 
2-4     4     0     2     1     5     2     5     12     31  
5-6     4     7     5     6     3     6     6     6     43  
7-10     17     5     5     17     16     16     13     9     98  
Stage of prostate cancer [5]
[units: participants]
                 
Localized     10     1     3     3     1     6     8     14     46  
Locally advanced     6     6     5     14     8     10     5     9     63  
Metastatic     9     3     4     6     12     6     10     2     52  
Not classifiable     0     2     0     1     3     2     1     2     11  
Body mass index [2]
[units: kilogram per square meter]
Mean ± Standard Deviation
  26.2  ± 2.97     26.6  ± 4.58     26.3  ± 3.74     25.9  ± 2.99     24.5  ± 2.92     26.9  ± 3.18     24.8  ± 2.72     27.1  ± 3.63     26.0  ± 3.32  
Time since prostate cancer diagnosis [2]
[units: days]
Mean ± Standard Deviation
  83  ± 157     66  ± 53     222  ± 328     146  ± 298     252  ± 560     303  ± 837     121  ± 425     47  ± 54     156  ± 439  
Weight [2]
[units: kilogram]
Mean ± Standard Deviation
  77.8  ± 12.4     82.2  ± 12.1     80.7  ± 11.8     78.2  ± 13.7     74.2  ± 9.88     81.5  ± 10.7     73.5  ± 9.55     81.7  ± 11.1     78.4  ± 11.6  
[1] Intention-to-treat (ITT) population.
[2] ITT population.
[3] ITT population. A curative intent of Yes refers to participants who have been castrated via radical prostatectomy or radiotherapy.
[4] ITT population. 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.
[5] ITT population. 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.



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

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


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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.  


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


No publications provided


Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00215657     History of Changes
Other Study ID Numbers: FE200486 CS07A
Study First Received: September 20, 2005
Results First Received: January 22, 2009
Last Updated: May 18, 2011
Health Authority: Denmark: The Ministry of the Interior and Health