Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Hide Participant Flow

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
  Hide 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  
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


  More Information