A Phase 1 Trial of Vandetanib (a Multi-kinase Inhibitor of EGFR, VEGFR and RET Inhibitor) in Combination With Everolimus (an mTOR Inhibitor) in Advanced Cancer
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose
level of the combination of vandetanib and everolimus based on when you join this study. Up
to 5 dose levels of vandetanib and everolimus will be tested. Up to 3 participants will be
enrolled at each dose level. The first group of participants will receive the lowest dose
level. Each new group will receive a higher dose than the group before it, if no
intolerable side effects were seen at the lower dose. This will continue until the highest
tolerable dose of the combination of vandetanib and everolimus is found.
Study Drug Administration:
You will take the study drugs by mouth 1 time every day. The number of pills you will be
taking each day will depend on which dose level you are in. The study staff will tell you
how many pills you will take and will give you detailed directions on how and when to take
the study drugs.
Everolimus should be taken with about a cup (8 ounces) of water, with or without food.
Swallow everolimus whole. Do not chew, break, or crush everolimus, unless you cannot
swallow it whole. In this case, crush the everolimus tablet and mix it with 2 tablespoons
of water if you are not able to swallow it whole.
Vandetanib can be taken with or without food. Do not chew, crush, or break vandetanib.
Vandetanib can be swallowed whole OR you can mix vandetanib with water. To do this, mix the
pill(s) with 1/4 cup of water for 10 minutes and then drink; then rinse the cup with ½ cup
more water and drink.
Study Visits:
At all study visits, you will be asked about any drugs you may be taking and if you have had
any side effects.
Within 14 days before Cycle 1:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- If it has been more than 3 days since your screening tests, blood (about 2 teaspoons)
and urine will be collected for routine tests.
At Weeks 2 and 4 of Cycle 1:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Before Cycle 2 and then before every cycle after that:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
- Blood (about 1 ½ teaspoon) will be drawn to test your blood sugar.
- You will have an ECG (every 2 cycles).
Before Cycle 3, and then before every odd numbered cycle after that (Cycles 5, 7, and so
on):
- Blood (about 2-5 teaspoons) will be drawn to test for fat and sugar levels in the
blood. You will need to fast (not eat or drink anything but water) for at least 4
hours before this blood draw.
- You will have an x-ray, CT scan, PET scan, or MRI scan to check the status of the
disease.
- If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine
pregnancy test.
Length of Study:
You may continue taking the study drugs for as long as the study doctor thinks it is in your
best interest. You will no longer be able to take the study drugs if the doctor no longer
thinks it is in your best interest, if the disease gets worse, or if intolerable side
effects occur.
You may choose to stop taking the study drugs at any time. You should tell the study staff
or doctor right away if you are thinking about stopping your participation in this study.
The study staff or doctor will talk to you about how to safely stop taking the study drugs.
You may be asked to return for a follow up visit to check if any side effects happen to you.
End-of-Study Visit:
If the study doctor thinks it is needed, you may have an end-of-study visit between 14 and
28 days after your last dose of study drugs. The following tests and procedures will be
performed:
- You will be asked about any drugs that you may be taking and if you have any side
effects.
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
- You may have an electrocardiogram (ECG).
- If you are able to become pregnant will have a blood (about 1 teaspoon) or urine
pregnancy test.
This is an investigational study. Vandetanib is FDA-approved and commercially available for
the treatment of medullary thyroid carcinoma. Everolimus is FDA-approved and commercially
available for the treatment of pancreatic neuroendocrine tumor, subependymal giant cell
astrocytoma, and renal cell carcinoma. The use of these drugs in combination for the
treatment of advanced cancer is investigational.
Up to 118 patients will take part in this multicenter 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
Maximum Tolerated Dose (MTD) of Vandetanib with Everolimus
Maximum tolerated dose (MTD) defined as highest dose studied in which incidence of dose limiting toxicity (DLT) less than 33%. MTD defined by DLTs that occur in first 28-day cycle (induction phase).
28 days
No
Vivek Subbiah, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2011-0953
NCT01582191
May 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |