Phase II Study of SB1518 for Patients With Myelodysplastic Syndrome (MDS)
18 Years
N/A
Both
Leukemia
Trial Information
Phase II Study of SB1518 for Patients With Myelodysplastic Syndrome (MDS)
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 the same
time every day.
You will receive your monthly supply of SB1518 during your clinic visit. The capsules should
not be opened or crushed. Do not touch the powder in the capsules. If you do, wash effected
areas thoroughly with water.
Each study cycle is 28 days.
Study Visits:
At every study visit, you will be asked about any drugs you may be taking, and any side
effects you have had.
One (1) time a week during Cycle 1, blood (about 2 tablespoons) will be drawn for routine
tests.
On Day 1 of Cycles 2 and beyond, blood (about 2 tablespoons) will be collected for routine
tests.
On Day 28 of each cycle, you will have a bone marrow aspirate and/or biopsy to check the
status of the disease. If the screening bone marrow test showed unusual genetic test
results, these samples will be used for cytogenetic testing. If you have a response to
therapy, you will have a bone marrow aspirate and/or biopsy every 3 cycles, if your doctor
thinks it needed.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drug if the disease gets worse, if
intolerable side effects occur, you are able to undergo allogeneic bone marrow
transplantation, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-treatment
visit.
End-of-Treatment Visit:
At 30 days after your last dose of study drug, you will have an end-of-treatment visit.
- You will be asked about any drugs you may be taking, and any side effects you have had.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- You will have a bone marrow aspirate and/or biopsy to check the status of the disease,
if your doctor thinks it is needed.
This is an investigational study. SB1518 is not FDA approved or commercially available. It
is currently being used for research purposes only.
Up to 40 participants will take part in this study. All will be enrolled at MD Anderson.
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 indicating that patients are aware of the investigational
nature of this study in keeping with the policies of UTMDACC.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants with Overall Response
Outcome 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.
Outcome Time Frame:
28 days
Safety Issue:
No
Principal Investigator
Guillermo Garcia-Manero, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
2011-0427
NCT ID:
NCT01436084
Start Date:
December 2011
Completion Date:
June 2013
Related Keywords:
- Leukemia
- Leukemia
- Myelodysplastic syndrome
- MDS
- SB1518
- Leukemia
- Myelodysplastic Syndromes
- Preleukemia
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
