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Pilot Study of mTOR Inhibitor Therapy in Peutz-Jeghers Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:
Information provided by (Responsible Party):

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

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

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


  More Information