Ignite Creation Date:
2024-05-06 @ 1:11 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01752400
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2012-12-07
Brief Title:
AUY922 for Advanced ALK-positive NSCLC
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase II Open-Label Trial of AUY922 an HSP90 Inhibitor in Patients With ALK-Rearranged Advanced Non-Small Cell Lung Cancer and Acquired Resistance to Prior ALK Tyrosine Kinase Inhibition
Status:
COMPLETED
Status Verified Date:
2018-03
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:
This research study is a Phase II clinical trial which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer Investigational means that the drug is being studied and that research doctors are trying to find out more about it-such as the safest dose to use the side effects it may cause and if the drug is effective for treating your type of cancer It also means that the FDA has not yet approved the drug for your type of cancer or for any use outside of research studies
It has been found that some people with NSCLC have a change mutation in a certain gene called the ALK gene This mutated gene helps cancer cells grow There is a drug crizotinib that has been approved by the FDA for the treatment of people with NSCLC who have mutations in the ALK gene Most people respond to crizotinib initially Over time however patients may stop responding become resistant to crizotinib because of additional changes in the ALK gene that makes crizotinib ineffective
AUY922 is an investigational drug that may stop cancer cells from growing abnormally This drug has been used in other research studies Information from those other research studies suggests that AUY922 may be effective in killing cancer cells that have become resistant to drugs like crizotinib Only participants with changes in the ALK gene will be allowed to participate in this study
The purpose of this study is to test the safety of AUY922 and determine how well AUY922 treats participants with advanced ALK-positive NSCLC
It has been found that some people with NSCLC have a change mutation in a certain gene called the ALK gene This mutated gene helps cancer cells grow There is a drug crizotinib that has been approved by the FDA for the treatment of people with NSCLC who have mutations in the ALK gene Most people respond to crizotinib initially Over time however patients may stop responding become resistant to crizotinib because of additional changes in the ALK gene that makes crizotinib ineffective
AUY922 is an investigational drug that may stop cancer cells from growing abnormally This drug has been used in other research studies Information from those other research studies suggests that AUY922 may be effective in killing cancer cells that have become resistant to drugs like crizotinib Only participants with changes in the ALK gene will be allowed to participate in this study
The purpose of this study is to test the safety of AUY922 and determine how well AUY922 treats participants with advanced ALK-positive NSCLC
Detailed Description:
If you agree to participate in this research study you will be asked to undergo some screening tests or procedures to find out if you can be in the research study Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study If you have had some of these tests or procedures recently they may or may not have to be repeated These test include a medical history physical exam performance status assessment of tumor EKG echocardiogram or multigated acquisition scan eye exam blood draw blood pregnancy test urine tset and collection of a piece of stored tumor tissue If these tests show you are eligible to participate in the research study you will begin the study treatment If you do not meet the eligibility criteria you will not be able to participate in this research study
Study treatment is given in 21 day cycles AUY922 is given by IV into a vein This is called an infusion You will receive an infusion of AUY922 jon days 18 and 15 of each cycle once per week The infusion will take about 60 minutes
A schedule of clinic visits for the study is summarized below At every visit you should tell the study staff how you are feeling and whether your health has changed you may have other lab tests done as part of the the care of your cancer in addition to those listed below
Cycle 1 Day 1 physical examination performance status EKG Blood draw and routine urine tests
Cycle 1 Day 2 EKG
Cycle 1 Day 3 EKG
Cycle 1 Day 8 measurement of weight and vital signs performance status EKG questions about side effects you may have and medications you are taking
Cycle 1 Day 15 physical exam performance status EKG blood draw questions about side effects you may have and medications you are taking
Note that in Cycle 1 you will need to stay at or return to the clinic for the last EKG following the Day 1 AUY922 infusion and come to the clinic on Days 2 and 3 for EKGs
Cycle 2 and beyond Day 1 physical exam performance status EKG blood draw questions about side effects you may have and medications you are taking routine urine test
Cycle 2 and beyond Day 8 measurement of weight and vital signs performance status EKG questions about side effects and medications
Cycle 2 and beyond Day 15 physical exam vital signs performance status EKG blood draw questions about side effects and medications
Additional EKGs may be done at any time if your study doctor thinks it is necessary A blood test to measure the amount of cardiac enzymes in your blood may be done whenever abnormal findings such as heart rhythm changes are suspected or seen on the EKG CT or MRI scans will be done to measure your disease about every 6 weeks A blood pregnancy test for women who can become pregnant will be performed every 6 weeks or at any point in which pregnancy is suspected A standard eye exam will be done on Cycle 3 Day 1 Additional eye exams will be done if you experience any eye-related symptoms such as changes in vision
Within 1 week after your last dose of the study drug AUY922 you will be asked to return to the clinic for an End of Treatment Visit At this visit the following will be done physical examination performance status ECG ECHO or MUGA scan blood draw urine test eye exam questions about side effects you may have and medications you are taking
You will be asked to return to the clinic about 3 weeks after the End of Treatment Visit about 4 weeks after the last dose of AUY922 so we can follow-up on any side effects you may still be experiencing after stopping AUY922
If you decide to stop study treatment for a reason other than progression of your disease you will be asked to have follow-up CT scans or MRIs every 12 weeks to continue to monitor the status of your cancer If your tumors get worse you will not need to have any further CT scans or MRIs as part of the study
If your disease does progress we would like to contact you by telephone about every 3 months to check on your status This will be done until after the last participant stops study treatment or for as long as you allow us to contact you Keeping in touch with you and checking on your condition helps us look at the long term effects of the research
You can continue to receive AUY922 for as long as your cancer does not progress and you do not experience unacceptable side effects
Study treatment is given in 21 day cycles AUY922 is given by IV into a vein This is called an infusion You will receive an infusion of AUY922 jon days 18 and 15 of each cycle once per week The infusion will take about 60 minutes
A schedule of clinic visits for the study is summarized below At every visit you should tell the study staff how you are feeling and whether your health has changed you may have other lab tests done as part of the the care of your cancer in addition to those listed below
Cycle 1 Day 1 physical examination performance status EKG Blood draw and routine urine tests
Cycle 1 Day 2 EKG
Cycle 1 Day 3 EKG
Cycle 1 Day 8 measurement of weight and vital signs performance status EKG questions about side effects you may have and medications you are taking
Cycle 1 Day 15 physical exam performance status EKG blood draw questions about side effects you may have and medications you are taking
Note that in Cycle 1 you will need to stay at or return to the clinic for the last EKG following the Day 1 AUY922 infusion and come to the clinic on Days 2 and 3 for EKGs
Cycle 2 and beyond Day 1 physical exam performance status EKG blood draw questions about side effects you may have and medications you are taking routine urine test
Cycle 2 and beyond Day 8 measurement of weight and vital signs performance status EKG questions about side effects and medications
Cycle 2 and beyond Day 15 physical exam vital signs performance status EKG blood draw questions about side effects and medications
Additional EKGs may be done at any time if your study doctor thinks it is necessary A blood test to measure the amount of cardiac enzymes in your blood may be done whenever abnormal findings such as heart rhythm changes are suspected or seen on the EKG CT or MRI scans will be done to measure your disease about every 6 weeks A blood pregnancy test for women who can become pregnant will be performed every 6 weeks or at any point in which pregnancy is suspected A standard eye exam will be done on Cycle 3 Day 1 Additional eye exams will be done if you experience any eye-related symptoms such as changes in vision
Within 1 week after your last dose of the study drug AUY922 you will be asked to return to the clinic for an End of Treatment Visit At this visit the following will be done physical examination performance status ECG ECHO or MUGA scan blood draw urine test eye exam questions about side effects you may have and medications you are taking
You will be asked to return to the clinic about 3 weeks after the End of Treatment Visit about 4 weeks after the last dose of AUY922 so we can follow-up on any side effects you may still be experiencing after stopping AUY922
If you decide to stop study treatment for a reason other than progression of your disease you will be asked to have follow-up CT scans or MRIs every 12 weeks to continue to monitor the status of your cancer If your tumors get worse you will not need to have any further CT scans or MRIs as part of the study
If your disease does progress we would like to contact you by telephone about every 3 months to check on your status This will be done until after the last participant stops study treatment or for as long as you allow us to contact you Keeping in touch with you and checking on your condition helps us look at the long term effects of the research
You can continue to receive AUY922 for as long as your cancer does not progress and you do not experience unacceptable side effects
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