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Everolimus (RAD001) as Therapy for Patients With Systemic Mastocytosis

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ClinicalTrials.gov Identifier: NCT00449748
Recruitment Status : Completed
First Posted : March 21, 2007
Results First Posted : April 29, 2011
Last Update Posted : August 7, 2012
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Systemic Mastocytosis
Intervention: Drug: RAD001 (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
Recruitment Period 4/11/2007 to 4/15/2009. All patients registered at The University of Texas M.D. Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
RAD001 Oral RAD001 10 mg daily for 30 days

Participant Flow:   Overall Study
    RAD001
STARTED   10 
COMPLETED   10 
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
RAD001 Oral RAD001 10 mg daily for 30 days

Baseline Measures
   RAD001 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Years]
Median (Full Range)
 56 
 (43 to 75) 
Gender 
[Units: Participants]
 
Female   6 
Male   4 
Region of Enrollment 
[Units: Participants]
 
United States   10 


  Outcome Measures

1.  Primary:   Number of Participants With Objective Response   [ Time Frame: Monthly for first 3 months, then every 3 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
No text entered.


  More Information

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


Results Point of Contact:  
Name/Title: Srdan Verstovsek M.D./Associate Professor
Organization: The University of Texas M. D. Anderson Cancer Cent
phone: 713-792-7305
e-mail: eharriso@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00449748     History of Changes
Other Study ID Numbers: 2006-0759
First Submitted: March 19, 2007
First Posted: March 21, 2007
Results First Submitted: April 4, 2011
Results First Posted: April 29, 2011
Last Update Posted: August 7, 2012