Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 16 for:    "Peutz-Jeghers Syndrome"

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:
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
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description All patients enrolled/eligible.
Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title All Patients
Hide Arm/Group Description All patients enrolled/eligible.
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants
34.6667  (18.71719)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
3
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title The Size of Intestinal Polyps
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small enrollment number, analysis was not possible.
Arm/Group Title All Patients
Hide Arm/Group Description:
All enrolled/eligible patients.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description All enrolled/eligible patients.
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%)
Total   0/3 (0.00%) 
Early termination leading to small numbers of subjects analyzed
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Randall Burt
Organization: Huntsman Cancer Institute
Phone: 801-585-3281
EMail: randall.burt@hci.utah.edu
Layout table for additonal information
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00811590     History of Changes
Other Study ID Numbers: HCI26943
First Submitted: November 17, 2008
First Posted: December 19, 2008
Results First Submitted: March 6, 2012
Results First Posted: July 4, 2012
Last Update Posted: July 26, 2013