Ignite Creation Date:
2024-05-05 @ 11:52 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01436084
Status:
TERMINATED
Last Update Posted:
2016-07-13
First Post:
2011-09-15
Brief Title:
SB1518 for Patients With Myelodysplastic Syndrome MDS
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of SB1518 for Patients With Myelodysplastic Syndrome MDS
Status:
TERMINATED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Colloborating sponsor decision
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 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
SB1518 is designed to block JAK2 and FLT3 SB1518 may have anti-tumor activity in certain leukemias myelofibrosis and lymphoma
Detailed Description:
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 andor 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 andor 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 andor 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
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 andor 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 andor 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 andor 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
Study Oversight
Has Oversight DMC:
None
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?:
None