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Study of LBH589 for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

This study has been terminated.
(Low Accrual)
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00939159
First received: July 10, 2009
Last updated: June 3, 2015
Last verified: June 2015
Results First Received: June 3, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Myelodysplastic Syndrome
Intervention: Drug: LBH589

  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: August 05, 2009 to March 10, 2011. All recruitment done at The University of Texas (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 seventeen (17) participants enrolled, four were excluded prior to receiving treatment on the study.

Reporting Groups
  Description
LBH589 LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.

Participant Flow:   Overall Study
    LBH589
STARTED   13 
COMPLETED   13 
NOT COMPLETED   0 



  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
  Description
LBH589 LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.

Baseline Measures
   LBH589 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Years]
Median (Full Range)
 70 
 (47 to 84) 
Gender 
[Units: Participants]
 
Female   5 
Male   8 
Region of Enrollment 
[Units: Participants]
 
United States   13 


  Outcome Measures

1.  Primary:   Overall Response Rate Based on the Hematologic Improvement   [ Time Frame: Assessment with 28-day cycle until response, then every 3 cycles as needed ]


  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
Early termination leading to small numbers of subjects analyzed.


  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: Guillermo Garcia-Manero, MD / Associate Professor
Organization: UT MD Anderson Cancer Center
phone: 713-792-7305
e-mail: eharriso@mdanderson.org


Publications of Results:

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00939159     History of Changes
Other Study ID Numbers: 2007-0713
Study First Received: July 10, 2009
Results First Received: June 3, 2015
Last Updated: June 3, 2015
Health Authority: United States: Food and Drug Administration