Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-25 @ 11:08 PM
Study NCT ID:
NCT00939159
Status:
TERMINATED
Last Update Posted:
2018-08-23
First Post:
2009-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of LBH589 for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase II Study of LBH589 for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
Status:
TERMINATED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to learn if LBH589 can help to control lower-risk (low or intermediate-1 risk) MDS. The safety of this drug will also be studied.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: