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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00939159
Recruitment Status : Terminated (Low Accrual)
First Posted : July 14, 2009
Results First Posted : June 18, 2015
Last Update Posted : June 18, 2015
Novartis Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Myelodysplastic Syndrome
Intervention: Drug: LBH589

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

Participant Flow:   Overall Study

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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (47 to 84) 
[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

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

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

Publications of Results:

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00939159     History of Changes
Other Study ID Numbers: 2007-0713
First Submitted: July 10, 2009
First Posted: July 14, 2009
Results First Submitted: June 3, 2015
Results First Posted: June 18, 2015
Last Update Posted: June 18, 2015