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Pilot Study of mTOR Inhibitor Therapy in Peutz-Jeghers Syndrome

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ClinicalTrials.gov Identifier: NCT00811590
Recruitment Status : Terminated (The study was ended early due to low enrollment.)
First Posted : December 19, 2008
Results First Posted : July 4, 2012
Last Update Posted : July 26, 2013
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
University of Utah

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Peutz-Jeghers Syndrome
Intervention: Drug: Everolimus

  Participant Flow


  Baseline Characteristics

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 
Overall Participants Analyzed 
[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

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