EphA2 Gene Targeting Using Neutral Liposomal Small Interfering RNA Delivery (IND# 72924): A Phase I Clinical Trial
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose
level of siRNA-EphA2-DOPC based on when you join this study. Up to 5 dose levels of
siRNA-EphA2-DOPC will be tested. Up to 6 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.
This will continue until the highest tolerable dose of siRNA-EphA2-DOPC is found.
Study Drug Administration:
You will receive siRNA-EphA2-DOPC 2 times a week (Days 1 and 4 of each week) by vein over 30
minutes (+/- 10 minutes).
Cycles in this study are 3 weeks long.
Study Visits:
On Day 1 of Cycle 1, if you have not already had these procedures done within the last week:
- Any updates to your medical history will be recorded, including any drugs you may be
taking and any side effects you may be having.
- You will have a physical exam, including measurement of your vital signs and weight.
- Your performance status will be recorded.
- Blood (about 4-6 teaspoons) will be drawn for routine tests. If you are able to become
pregnant, this blood will also be used for a pregnancy test. Urine will also be
collected for a pregnancy test.
- Blood (about 2 teaspoons each time) will be drawn for pharmacokinetic (PK) testing
before the study drug dose, 1 time during the dose, at the end of the dose, and 6 times
during the 6 hours after the dose. PK testing measures the amount of study drug in the
body at different time points.
On Day 2 of Cycle 1 (24 hours after the first study drug dose), blood (about 2 teaspoons)
will be drawn for PK testing.
On Day 3 or 4 of Cycle 1:
- You will have a core biopsy at the same site(s) that may have been tested at screening
to check the status of the disease. This sample will be compared to the sample
collected at screening.
- Blood (about 4 teaspoons) will be drawn for biomarker testing close to the time of the
tissue biopsy.
- You will have an FDG-PET scan, DCE-MRI scan, and a DWI-MRI to check the status of the
disease and to learn how the drug may be affecting the tumor.
- On Day 4 only, blood (about 2 teaspoons each time) will be drawn for PK testing before
and at the end of the study drug dose.
During Weeks 2 and 3 of Cycle 1:
- Blood (about 2 teaspoons each time) will be drawn for routine tests before each dose of
study drug.
- Blood (about 4 teaspoons each time) will be drawn for biomarker testing after each dose
of study drug.
- You will be asked about any side effects you may be having.
Before Cycle 2, you will have an FDG-PET scan to learn how your cells may be affecting the
tumor.
On Day 1 of Cycle 2:
- You will have a physical exam, including measurement of your vital signs, height, and
weight.
- You will be asked about any drugs you may be taking and about any side effects you may
be having.
- Your performance status will be recorded.
- Blood (about 6 teaspoons) will be drawn for routine tests and biomarker testing.
- You will have an FDG-PET scan, DCE-MRI scan, and a DWI-MRI to check the status of the
disease and to learn how the drugs may be affecting the tumor.
- You will have a CT scan or x-ray to check the status of the disease.
During Weeks 2 and 3 of Cycles 2 and beyond:
- Blood (about 2 teaspoons each time) will be drawn for routine tests before each dose of
study drug.
- You will be asked about any side effects you may be having.
On Day 1 of every even numbered cycle (Cycles 2, 4, 6, and so on):
- You will have a CT scan or x-ray to check the status of the disease.
- Blood (about 4 teaspoons) will be drawn for biomarker testing.
Length of Dosing:
You may continue taking the study drug for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drug if the disease gets worse, if
intolerable side effects occur, if study drug dosing is delayed for more than 2 weeks, if
the disease completely responds, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-dosing
visit.
End-of-Dosing Visit:
After you have finished taking the study drug:
- You will have a physical exam, including measurement of your height and weight.
- You will be asked about any drugs you may be taking.
- Your performance status will be recorded.
- Blood (about 4-6 teaspoons) will be drawn for routine tests.
- Blood (about 4 teaspoons) will be drawn for biomarker testing.
- You will have a CT scan, MRI scan, or x-ray to check the status of the disease.
- If the doctor thinks it is needed, you will have an ECG.
This is an investigational study. siRNA-EphA2-DOPC is not FDA approved or commercially
available. It is currently being used for research purposes only.
Up to 30 patients will be enrolled on 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
Maximal Tolerated Dose (MTD)
Maximal tolerated dose (MTD) determined using a modified toxicity probability interval (mTPI) design. On Day 1 of Cycle 2, a FDG-PET scan, DCE-MRI scan, and a DWI-MRI done to check status of the disease and to learn how the drugs may be affecting the tumor. CT scan or x-ray to check status of the disease also done on Day 1 of Cycle 2.
22 days
Yes
Robert Coleman, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2011-0216
NCT01591356
September 2013
Name | Location |
---|---|
UT MD Andreson Cancer Center | Houston, Texas 77030 |