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Pilot Study of mTOR Inhibitor Therapy in Peutz-Jeghers Syndrome

This study has been terminated.
(The study was ended early due to low enrollment.)
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00811590
First received: November 17, 2008
Last updated: July 19, 2013
Last verified: July 2013
Results First Received: March 6, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Peutz-Jeghers Syndrome
Intervention: Drug: Everolimus

  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
No text entered.

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
All Patients All patients enrolled/eligible.

Participant Flow:   Overall Study
    All Patients  
STARTED     3  
COMPLETED     3  
NOT COMPLETED     0  



  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
All Patients All patients enrolled/eligible.

Baseline Measures
    All Patients  
Number of Participants  
[units: participants]
  3  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  34.6667  ± 18.71719  
Gender  
[units: participants]
 
Female     3  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     3  



  Outcome Measures

1.  Primary:   The Size of Intestinal Polyps   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  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
Early termination leading to small numbers of subjects analyzed


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Randall Burt
Organization: Huntsman Cancer Institute
phone: 801-585-3281
e-mail: randall.burt@hci.utah.edu


No publications provided


Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00811590     History of Changes
Other Study ID Numbers: HCI26943
Study First Received: November 17, 2008
Results First Received: March 6, 2012
Last Updated: July 19, 2013
Health Authority: United States: Food and Drug Administration