SB1518 for Patients With Myelodysplastic Syndrome (MDS)

This study has been terminated.
(Colloborating sponsor decision.)
Sponsor:
Collaborator:
S*BIO
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01436084
First received: September 15, 2011
Last updated: June 14, 2016
Last verified: June 2016
Results First Received: May 10, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Intervention: Drug: SB1518

  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: 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
  Description
SB1518 400 mg orally a day for 28 day cycle.

Participant Flow:   Overall Study
    SB1518  
STARTED     4  
COMPLETED     0  
NOT COMPLETED     4  
Disease Progression                 2  
Withdrawal by Subject                 1  
Early Closure of Study                 1  



  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
SB1518 400 mg orally a day for 28 day cycle.

Baseline Measures
    SB1518  
Number of Participants  
[units: participants]
  4  
Age  
[units: years]
Median (Full Range)
  69  
  (57 to 75)  
Gender  
[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
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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
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  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 / Professor, Leukemia
Organization: University of Texas (UT) MD Anderson Cancer Center
phone: 1-877-MDA-6789
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01436084     History of Changes
Other Study ID Numbers: 2011-0427
Study First Received: September 15, 2011
Results First Received: May 10, 2016
Last Updated: June 14, 2016
Health Authority: United States: Food and Drug Administration