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
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 1,8 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
Cycle 1, Day 1: physical examination, performance status, EKG, Blood draw and routine urine
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate
Evaluate the best objective response rate to AUY922
Alice Shaw, MD, PhD
Massachusetts General Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Beth Isreal Deaconess Medical Center||Boston, Massachusetts 02215|