Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

CEP-701 for PH-negative Myelofibrosis

This study has been completed.
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00494585
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
Myelofibrosis
Intervention: Drug: CEP-701

  Participant Flow
  Hide 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: 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
  Description
CEP-701 80 mg orally twice daily for 30 days

Participant Flow:   Overall Study
    CEP-701  
STARTED     22  
COMPLETED     22  
NOT COMPLETED     0  



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

Baseline Measures
    CEP-701  
Number of Participants  
[units: participants]
  22  
Age  
[units: years]
Median ( Full Range )
  61  
  ( 38 to 83 )  
Gender  
[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
  Hide 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
  Hide 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 Center
phone: 713-792-7305
e-mail: eharriso@mdanderson.org


No publications provided by M.D. Anderson Cancer Center

Publications automatically indexed to this study:

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov 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