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Sunitinib in Treating Patients With Idiopathic Myelofibrosis

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00387426
First received: October 12, 2006
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
Results First Received: July 5, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Accelerated Phase Chronic Myelogenous Leukemia
Acute Undifferentiated Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Blastic Phase Chronic Myelogenous Leukemia
Chronic Myelomonocytic Leukemia
Chronic Phase Chronic Myelogenous Leukemia
Mast Cell Leukemia
Meningeal Chronic Myelogenous Leukemia
Primary Myelofibrosis
Progressive Hairy Cell Leukemia, Initial Treatment
Prolymphocytic Leukemia
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Refractory Chronic Lymphocytic Leukemia
Refractory Hairy Cell Leukemia
Relapsing Chronic Myelogenous Leukemia
Secondary Acute Myeloid Leukemia
Stage I Chronic Lymphocytic Leukemia
Stage II Chronic Lymphocytic Leukemia
Stage III Chronic Lymphocytic Leukemia
Stage IV Chronic Lymphocytic Leukemia
T-cell Large Granular Lymphocyte Leukemia
Untreated Adult Acute Lymphoblastic Leukemia
Untreated Adult Acute Myeloid Leukemia
Untreated Hairy Cell Leukemia
Intervention: Drug: sunitinib malate

  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: September 14, 2006 to December 17, 2007. All recruitment done at UT MD Anderson Cancer Center.

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
Sunitinib 37.5 mg orally daily for 6-week cycle

Participant Flow:   Overall Study
    Sunitinib  
STARTED     14  
COMPLETED     0  
NOT COMPLETED     14  
Lack of Response                 7  
Toxicities                 4  
Disease Progression                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Sunitinib 37.5 mg orally daily for 6-week cycle

Baseline Measures
    Sunitinib  
Number of Participants  
[units: participants]
 		  14  
Age  
[units: years]
Median ( Full Range ) 		  64  
  ( 51 to 79 )  
Gender  
[units: participants]
 		 
Female     7  
Male     7  
Region of Enrollment  
[units: participants]
 		 
United States     14  



  Outcome Measures

1.  Primary:   Number of Participants With Objective Clinical Response to Sunitinib Therapy   [ Time Frame: After two 6-week treatment courses (12 weeks) ]
  Show Outcome Measure 1


  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
No text entered.  


Results Point of Contact:  
Name/Title: Srdan Verstovsek, MD / Associate Professor
Organization: UT MD Anderson Cancer Center
e-mail: eharriso@mdanderson.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00387426     History of Changes
Other Study ID Numbers: NCI-2009-00207, 2006-0208, CDR0000504056, N01CM62202
Study First Received: October 12, 2006
Results First Received: July 5, 2012
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration