Everolimus (RAD001) as Therapy for Patients With Systemic Mastocytosis

This study has been completed.

Study NCT00449748 Information provided by M.D. Anderson Cancer Center

First Received on March 19, 2007. Last Updated on April 4, 2011 History of Changes

Results First Received: April 4, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Systemic Mastocytosis
Intervention:	Drug: RAD001 (Everolimus)

Participant Flow

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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

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Reporting Groups

	Description
RAD001	Oral RAD001 10 mg daily for 30 days

Baseline Measures

	RAD001
Number of Participants [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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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
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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

No publications provided

Responsible Party:	Srdan Verstovsek, M.D./Associate Professor, The University of Texas M. D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00449748 History of Changes
Other Study ID Numbers:	2006-0759
Study First Received:	March 19, 2007
Results First Received:	April 4, 2011
Last Updated:	April 4, 2011
Health Authority:	United States: Food and Drug Administration