Ignite Creation Date:
2024-05-06 @ 3:03 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02196857
Status:
COMPLETED
Last Update Posted:
2020-01-14
First Post:
2014-07-18
Brief Title:
Sorafenib Plus 5-Azacitidine Initial Therapy of Patients With Acute Myeloid Leukemia AML and High Risk Myelodysplastic Syndrome MS With FLT3-ITD Mutation
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Sorafenib Plus 5-Azacitidine for the Initial Therapy of Patients With Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome With FLT3-ITD Mutation
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 5-azacitidine and sorafenib can help to control the disease in patients with Acute Myeloid Leukemia AML and high risk Myelodisplastic Syndrome MDS with FLT3-ITD mutation The safety of this drug combination will also be studied
Detailed Description:
Study Drug Administration
If you are found to be eligible to take part in this study you will receive 5-azacitidine either as an injection under the skin or by vein on Days 1-7 of each 28-day cycle If by vein the infusion will take about 10-40 minutes
You will take sorafenib by mouth 2 times a day about 12 hours apart with at least 1 cup 8 ounces of water on an empty stomach every day If you vomit a dose do not make it up You should wait and take your next scheduled dose
Each study cycle may last a little longer than 28 days depending on how you are doing
Study Visits
Each week blood about 1 tablespoon will be drawn for routine tests
Each week for the first 6 weeks and then as often as your doctor thinks it is needed you will have your blood pressure measured
Before each cycle you will have a physical exam
Before every 2-4 cycles you will have a bone marrow aspirate to check the status of the disease
Length of Study
You may continue taking the study drugs for as long as your doctor thinks it is in your best interest You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur or if you are unable to follow study directions
Your participation on the study will be over after the follow-up visits
End-of-Study Visit
After you have stopped taking the study drugs the following tests and procedures will be performed
You will have a physical exam
You will have a bone marrow aspirate to check the status of disease
Blood about 2 tablespoons will be drawn for routine tests
Follow-Up Visits
After your end-of-study visit you will return to the clinic every 3 months and have the following tests and procedures
You will have a physical exam
Blood about 2 tablespoons will be drawn for routine tests
This is an investigational study Sorafenib is FDA approved and commercially available for the treatment of kidney cancer and liver cancer 5-azacitidine is FDA approved for the treatment of MDS but combining it with sorafenib is investigational The study doctor can tell you how the study drugs are designed to work
Up to 52 participants will be enrolled in this study All will take part at MD Anderson
If you are found to be eligible to take part in this study you will receive 5-azacitidine either as an injection under the skin or by vein on Days 1-7 of each 28-day cycle If by vein the infusion will take about 10-40 minutes
You will take sorafenib by mouth 2 times a day about 12 hours apart with at least 1 cup 8 ounces of water on an empty stomach every day If you vomit a dose do not make it up You should wait and take your next scheduled dose
Each study cycle may last a little longer than 28 days depending on how you are doing
Study Visits
Each week blood about 1 tablespoon will be drawn for routine tests
Each week for the first 6 weeks and then as often as your doctor thinks it is needed you will have your blood pressure measured
Before each cycle you will have a physical exam
Before every 2-4 cycles you will have a bone marrow aspirate to check the status of the disease
Length of Study
You may continue taking the study drugs for as long as your doctor thinks it is in your best interest You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur or if you are unable to follow study directions
Your participation on the study will be over after the follow-up visits
End-of-Study Visit
After you have stopped taking the study drugs the following tests and procedures will be performed
You will have a physical exam
You will have a bone marrow aspirate to check the status of disease
Blood about 2 tablespoons will be drawn for routine tests
Follow-Up Visits
After your end-of-study visit you will return to the clinic every 3 months and have the following tests and procedures
You will have a physical exam
Blood about 2 tablespoons will be drawn for routine tests
This is an investigational study Sorafenib is FDA approved and commercially available for the treatment of kidney cancer and liver cancer 5-azacitidine is FDA approved for the treatment of MDS but combining it with sorafenib is investigational The study doctor can tell you how the study drugs are designed to work
Up to 52 participants will be enrolled in this study All will take part at MD Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2014-01702 | REGISTRY | NCI CTRP | None |