A Phase II Study of the HSP90 Inhibitor AUY922 in Patients With Relapsed and Refractory Lymphoma
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive AUY922 by vein
over about 1 hour on Days 1, 8, 15, and 22 of each 28-day cycle.
Study Visits:
On Day 1 of Cycles 1-12:
- You will have a physical exam, including measurement of your vital signs (blood
pressure, heart rate, temperature, and breathing rate).
- Your performance status will be recorded.
- You will be asked about any drugs you may be taking and any side effects you may have
had.
- Blood (about 6-7 teaspoons) will be drawn for routine tests and to check your heart
function.
- You will have multiple ECGs over 8 hours.
On Day 1 of Cycles 1 and 2:
- Urine will be collected for routine tests.
- Blood (about 1 teaspoon) will be drawn to check your blood clotting function.
On Days 2 and 3 of Cycle 1:
- Blood (about 5-6 teaspoons) will be drawn for routine tests.
- You will have multiple ECGs over 24 hours.
- You will be asked about any drugs you may be taking, any side effects you may be
having, and about your overall health.
On Day 8 of Cycles 1 and 2 and Day 15 of Cycles 1-12:
- Blood (about 5-6 teaspoons) will be drawn for routine tests.
- You will have multiple ECGs until 30 minutes after the infusion.
- Your vital signs will be measured.
- You will be asked about any drugs you may be taking, any side effects you may be
having, and about your overall health.
On Day 22 of Cycle 1:
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- You will be asked about any drugs you may be taking, any side effects you may be
having, and about your overall health.
- Blood (about 5-6 teaspoons) will be drawn for routine tests.
After every 2 cycles:
- You will have CT and PET scans to check the status of the disease.
- You will be asked about any side effects you may be having and about your overall
health.
Anytime the study doctor thinks it is needed, you will have an eye exam or other tests.
Length of Study:
You may continue taking AUY922 for up to 12 cycles. 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.
End-of-Treatment Visit:
At 28 days after your last dose:
- Blood (about 5-6 teaspoons) and urine will be collected for routine tests.
- Blood (about 1 teaspoon) will be drawn to check your blood clotting function.
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- You will have an eye exam by an eye doctor.
- You will have CT and PET scans to check the status of the disease.
- You will be asked about any drugs you may be taking, any side effects you may be
having, and about your overall health.
Long-Term Follow-Up:
After you stop the study drug, you will have a CT scan and physical exam every 3 months for
1 year, then every 4 months for another year, and every 6 months for 3 years and then 1 time
a year after that.
This is an investigational study. AUY922 is not FDA approved or commercially available. It
is currently being used for research purposes only.
Up to 42 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants with Objective Response
Objective Response defined as Complete (CR) and Partial (PR) Response. Computed tomography (CT) and Positron emission tomography (PET) scans done after every 2 cycles to assess efficacy using Cheson Criteria (2007) which lists CR as disappearance of all evidence of disease, and PR as regression of measurable disease and no new sites.
56 days
No
Yasuhiro Oki, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2011-0467
NCT01485536
August 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |