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SB1518 for Patients With Myelodysplastic Syndrome (MDS)

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
S*BIO
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
Enrollment 8
Recruitment Details 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 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.
Arm/Group Title SB1518
Hide Arm/Group Description 400 mg orally a day for 28 day cycle.
Period Title: Overall Study
Started 4
Completed 0
Not Completed 4
Reason Not Completed
Disease Progression             2
Withdrawal by Subject             1
Early Closure of Study             1
Arm/Group Title SB1518
Hide Arm/Group Description 400 mg orally a day for 28 day cycle.
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
69
(57 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
1
  25.0%
Male
3
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Number of Participants With Overall Response
Hide Description Overall response based on hematologic improvement defined by International Working Group (IWG) response criteria in myelodysplasia. Complete remission (CR): Bone marrow of 5% myeloblasts with normal maturation of all cell lines, noted persistent dysplasia; Partial Remission: CR criteria if abnormal before treatment except Bone marrow blasts decreased by 50% over pretreatment but still > 5%; Marrow CR: Bone marrow 5% myeloblasts and decrease by 50% over pretreatment. Bone marrow aspirate pre-therapy (Day 0) and on Day 28 of first cycle then every 3 cycles. Responses must last at least 4 weeks.
Time Frame 28 days to one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study was halted prior to completion of treatment and assessment for any participant(s).
Arm/Group Title SB1518
Hide Arm/Group Description:
400 mg orally a day for 28 day cycle.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data collected during 28 day drug cycles to thirty days following the last dose of study drug. In the absence of treatment delays due to adverse events, treatment may continue indefinitely. Study period December 2011 to January 2012.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SB1518
Hide Arm/Group Description 400 mg orally a day for 28 day cycle.
All-Cause Mortality
SB1518
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SB1518
Affected / at Risk (%) # Events
Total   0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SB1518
Affected / at Risk (%) # Events
Total   2/4 (50.00%)    
Gastrointestinal disorders   
Gastrointestinal (GI) Other  1  1/4 (25.00%)  1
Diarrhea  1  2/4 (50.00%)  2
Heartburn  1  1/4 (25.00%)  1
General disorders   
Abdominal pain  1  1/4 (25.00%)  1
Nausea  1  2/4 (50.00%)  2
Fatigue  1  2/4 (50.00%)  2
Pain Other  1  1/4 (25.00%)  1
Vomiting  1  1/4 (25.00%)  1
Skin and subcutaneous tissue disorders   
Sweating  1  1/4 (25.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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
ClinicalTrials.gov 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