Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-01-13 @ 9:08 AM
Study NCT ID:
NCT02271906
Status:
TERMINATED
Last Update Posted:
2019-04-30
First Post:
2014-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor 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 it is tolerable for patients with NSCLC to receive afatinib before surgery. The safety of this drug will also be studied.
Detailed Description:
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take afatinib by mouth 1 time a day for at least 14 days before your surgery. You should take it at least 1 hour before or 2 hours after a meal. You will sign a separate consent form that describes the surgery and its risks in more detail.
You will keep a diary of when you take the pills. You should bring the diary to each visit, along with your pill bottle so the study staff can count any remaining pills.
Some side effects, such as diarrhea and skin rash, will occur in almost all patients. If you have severe side effects, your dose may be lowered.
Study Visits:
One (1) time a week while you are taking afatinib:
* You will have a physical exam.
* Blood (about 3 teaspoons) will be drawn for routine tests.
Within a week before your surgery:
* You will have a physical exam.
* Blood (about 3 teaspoons) will be drawn for routine tests.
* You will have a PET-CT scan to check the status of the disease.
* You will have a MUGA scan to check your heart function.
On the day of surgery, blood (about 3 teaspoons) will be drawn for research tests, including looking for tumor cells that may be in the blood.
Leftover tissue from surgery will be used for biomarker testing.
Length of Treatment:
You will take your last dose of study drug within 24 hours before your surgery. You will no longer be able to take the study drug if the disease gets worse, if 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 visit.
Follow-Up:
At about 30 days after surgery:
* You will have a physical exam.
* Blood (about 3 teaspoons) will be drawn for routine tests.
It is possible that the study staff will call you instead of the visit above. You will be asked how you are doing. The call should last about 5 minutes.
If you are having side effects from the study drug at the time of the follow-up visit or call, you may have additional follow-up if the doctor thinks it is needed. The follow-up tests, procedures, and schedule will be the doctor's decision depending on the side effects.
This is an investigational study. Afatinib is FDA approved and commercially available to be the first treatment for patients with a specific type of NSCLC that has spread. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.
Up to 20 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 take afatinib by mouth 1 time a day for at least 14 days before your surgery. You should take it at least 1 hour before or 2 hours after a meal. You will sign a separate consent form that describes the surgery and its risks in more detail.
You will keep a diary of when you take the pills. You should bring the diary to each visit, along with your pill bottle so the study staff can count any remaining pills.
Some side effects, such as diarrhea and skin rash, will occur in almost all patients. If you have severe side effects, your dose may be lowered.
Study Visits:
One (1) time a week while you are taking afatinib:
* You will have a physical exam.
* Blood (about 3 teaspoons) will be drawn for routine tests.
Within a week before your surgery:
* You will have a physical exam.
* Blood (about 3 teaspoons) will be drawn for routine tests.
* You will have a PET-CT scan to check the status of the disease.
* You will have a MUGA scan to check your heart function.
On the day of surgery, blood (about 3 teaspoons) will be drawn for research tests, including looking for tumor cells that may be in the blood.
Leftover tissue from surgery will be used for biomarker testing.
Length of Treatment:
You will take your last dose of study drug within 24 hours before your surgery. You will no longer be able to take the study drug if the disease gets worse, if 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 visit.
Follow-Up:
At about 30 days after surgery:
* You will have a physical exam.
* Blood (about 3 teaspoons) will be drawn for routine tests.
It is possible that the study staff will call you instead of the visit above. You will be asked how you are doing. The call should last about 5 minutes.
If you are having side effects from the study drug at the time of the follow-up visit or call, you may have additional follow-up if the doctor thinks it is needed. The follow-up tests, procedures, and schedule will be the doctor's decision depending on the side effects.
This is an investigational study. Afatinib is FDA approved and commercially available to be the first treatment for patients with a specific type of NSCLC that has spread. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.
Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2015-00357 | REGISTRY | NCI CTRP | View |