SB1518 for Patients With Myelodysplastic Syndrome (MDS)

Stopped early · Phase 2

Conditions studied: Leukemia

In brief

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. SB1518 may have anti-tumor activity in certain leukemias, myelofibrosis, and lymphoma.

Key facts

Study ID

NCT01436084

Run by

M.D. Anderson Cancer Center

People needed

8

Starts

2011-12-01

Expected to finish

2013-06-01

Last updated by the study team

2016-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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