Phase II Study of LBH589 for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
Study Drug:
LBH589 is a drug that may slow down the growth of cancer cells or kill cancer cells by
blocking certain enzymes (proteins produced by cells).
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take LBH589 capsules by
mouth 3 times a week for 3 weeks (for example on Days 1, 3, 5, 8, 10,12, 15, 17, and 19)
then 1 week of rest of each 28-day study "cycle."
You should take LBH589 at the same time each morning. Each dose of LBH589 should be taken
with 1 cup (8 ounces) of water.
You should swallow the capsules whole and not chew them. You must not eat grapefruit and
Seville (sour) oranges or drink their juices during your entire participation on the study.
If you vomit while taking LBH589, then you should wait until your next scheduled dose to
take another capsule. If you forget to take your capsules in the morning, you can take them
up to 12 hours after the usual time you take it. After 12 hours, do not take LBH589 that
day. Instead, wait until your next scheduled dose. Do not make up missed doses.
Call your study doctor or study staff as soon as possible if you have any unusual symptoms.
Do not wait until your next visit to tell your doctor about your symptoms. If you have side
effects at your assigned dose level, then your dose may be lowered. You may also have to
stop taking LBH589 for a short period, and the side effect(s) will be watched by your doctor
until they resolve.
Take the drug just as the doctor tells you. Do not miss any capsules. You will be asked to
return all study drug in the bottles provided, whether your take all the capsules or not.
Empty bottles should also be brought back to the clinic. Capsules should not be transferred
between bottles at any time.
At each visit, you must tell the study staff about any other drugs you are taking during the
study. This includes prescription drugs, over-the-counter drugs, and vitamins. Your study
doctor will tell you if you need to stop taking any of these drugs.
Study Visits:
At least every week during Cycle 1 and every cycle after that, you will have the following
tests and procedures performed:
- Blood (about 1 tablespoon) will be drawn for routine tests
- You will have a physical exam, including measurement of your vital signs.
On Day 21 (+/- 7 days) of Cycle 1, you will have a bone marrow biopsy/aspirate to check the
status of the disease.
On Days 1 and 5 of Cycle 1, and Days 5 and 22 of Cycles 2 and beyond, you will have ECGs.
If your doctor thinks it is necessary, you may have ECGs more often.
On Day 1 of Cycle 2 and beyond you will have EKG prior to taking the study medication.
Length of Study:
You may continue taking the study drug for up to 24 months. You will be taken off study if
intolerable side effects occur or the disease gets worse.
End of Study Visit:
When you stop taking LBH589, you will have the following tests and procedures performed:
- Blood (about 1 tablespoon) will be drawn for routine tests
- You will have a bone marrow aspiration and biopsy to check the status of the disease.
- You will have a physical exam, including measurement of your vital signs.
- You will have a performance status evaluation.
- You will have an ECG.
This is an investigational study. LBH589 is not FDA approved or commercially available. At
this time, LBH589 is only being used for research.
Up to 40 participants will take part in this study. All will be enrolled at M. D. Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate based on the hematologic improvement
Treatement cycle of 4 weeks
Yes
Guillermo Garcia-Manero, MD
Study Chair
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2007-0713
NCT00939159
August 2009
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |