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CEP-701 for PH-negative Myelofibrosis

This study has been completed.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: June 28, 2007
Last updated: June 19, 2012
Last verified: June 2012
Results First Received: April 7, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
Intervention: Drug: CEP-701

  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: 6/28/2007 through 10/25/2007. All participants recruited 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
Of the 27 participants registered, 5 participants were ineligible to participate.

Reporting Groups
CEP-701 80 mg orally twice daily for 30 days

Participant Flow:   Overall Study
STARTED     22  
COMPLETED     22  

  Baseline Characteristics
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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
CEP-701 80 mg orally twice daily for 30 days

Baseline Measures
Number of Participants  
[units: participants]
[units: years]
Median ( Full Range )
  ( 38 to 83 )  
[units: participants]
Female     6  
Male     16  
Region of Enrollment  
[units: participants]
United States     22  

  Outcome Measures

1.  Primary:   Number of Participants With Objective Response   [ Time Frame: Response assessed after each 3 cycles (cycle = 30 days) ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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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
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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 Center
phone: 713-792-7305

No publications provided by M.D. Anderson Cancer Center

Publications automatically indexed to this study:

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00494585     History of Changes
Other Study ID Numbers: 2007-0070, CS-2007-20040
Study First Received: June 28, 2007
Results First Received: April 7, 2011
Last Updated: June 19, 2012
Health Authority: United States: Food and Drug Administration