Status:
TERMINATED
SB1518 for Patients With Myelodysplastic Syndrome (MDS)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
S*BIO
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if SB1518 can help to control myelodysplastic syndrome. The safety of the drug will also be studied. SB1518 is designed to block JAK2 and FLT3. SB...
Detailed Description
Study Drug Administration: If you are found to be eligible to take part in this study, you will take SB1518 by mouth 1 time every day. You can take it with or without food, and it should be taken at ...
Eligibility Criteria
Inclusion
- Patients with MDS by the IPSS classification including low, int-1, int-2, and high risk are eligible. Patients should have received at least one line of prior therapy including growth factors, lenalidomide, or hypomethylating agents.
- Signed informed consent.
- Age \>/= 18 years old.
- Patients must have the following non-hematologic values: Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) \</= 2.5 x Upper Limit of Normal (ULN) if both are available or \</= 5.0 x ULN if hepatic involvement is present as determined by the investigator; Serum bilirubin \</=2 x ULN; Serum creatinine \</= 2 x ULN or 24-hour creatinine clearance \>/= 50 ml/min
- Patients, if sexually active, must agree to use appropriate forms birth control.
Exclusion
- Uncontrolled intercurrent illness, including but not limited to ongoing active infection or psychiatric illness or social situations that the treating physician judges would limit compliance with study requirements. Patients receiving antibiotics for infections that are under control may be included in the study.
- History of myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure within 6 months prior to study enrollment;
- New York Heart Association Class III or IV congestive heart failure;
- Ongoing cardiac dysrhythmias of Grade \>/= 2, atrial fibrillation of any grade, QTc prolongation \> 470 ms or other factors that increase the risk of QT prolongation (e.g., heart failure; hypokalemia, defined as serum potassium \< 3.0 mEq/L; family history of long QT interval syndrome);
- Required use of a concomitant medication known to prolong the QT interval significantly.
- Known HIV seropositivity;
- Known active hepatitis A, B, or C;
- Women who are pregnant or lactating.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01436084
Start Date
December 1 2011
End Date
June 1 2013
Last Update
July 13 2016
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030