SB1518 for Patients With 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: NCT01436084
Recruitment Status : Terminated (Colloborating sponsor decision.)
First Posted : September 19, 2011
Results First Posted : June 15, 2016
Last Update Posted : July 13, 2016
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: Leukemia
Intervention: Drug: SB1518

  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: December 22, 2011 to January 24, 2012. 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
Four participants of the eight enrolled failed to meet the screening criteria and were not treated on the study. The study was closed to new patient entry 2 months after activation due to sponsor/collaborator issues; the only patient remaining was taken off study at that time.

Reporting Groups
SB1518 400 mg orally a day for 28 day cycle.

Participant Flow:   Overall Study
Disease Progression                2 
Withdrawal by Subject                1 
Early Closure of Study                1 

  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.
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Reporting Groups
SB1518 400 mg orally a day for 28 day cycle.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (57 to 75) 
[Units: Participants]
Female   1 
Male   3 
Region of Enrollment 
[Units: Participants]
United States   4 

  Outcome Measures

1.  Primary:   Number of Participants With Overall Response   [ Time Frame: 28 days to one year ]

  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
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  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 / Professor, Leukemia
Organization: University of Texas (UT) MD Anderson Cancer Center
phone: 1-877-MDA-6789

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01436084     History of Changes
Other Study ID Numbers: 2011-0427
First Submitted: September 15, 2011
First Posted: September 19, 2011
Results First Submitted: May 10, 2016
Results First Posted: June 15, 2016
Last Update Posted: July 13, 2016