Overview

SB1518 for Patients With Myelodysplastic Syndrome (MDS)

Status:
Terminated
Trial end date:
2013-06-01
Target enrollment:
0
Participant gender:
All
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. SB1518 may have anti-tumor activity in certain leukemias, myelofibrosis, and lymphoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
S*BIO
Criteria
Inclusion Criteria:

1. 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.

2. Signed informed consent.

3. Age >/= 18 years old.

4. Patients must have the following non-hematologic values: Aspartate aminotransferase
(AST/SGOT) and alanine aminotransferase (ALT/SGPT) (ULN) if both are available or determined by the investigator; Serum bilirubin ULN or 24-hour creatinine clearance >/= 50 ml/min

5. Patients, if sexually active, must agree to use appropriate forms birth control.

Exclusion Criteria:

1. 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.

2. History of myocardial infarction, severe/unstable angina, or symptomatic congestive
heart failure within 6 months prior to study enrollment;

3. New York Heart Association Class III or IV congestive heart failure;

4. 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);

5. Required use of a concomitant medication known to prolong the QT interval
significantly.

6. Known HIV seropositivity;

7. Known active hepatitis A, B, or C;

8. Women who are pregnant or lactating.