A Phase I Trial of ZIO-101 in Hematologic Cancers
The purpose of this study is to find answers to the following questions:
1. What is the largest dose of ZIO-101 that can be given once a day for 5 days every 4
weeks (a "cycle")?
2. What are the side effects of ZIO-101 when administered in this way?
3. After getting the drug how much of the ZIO-101 remains in the blood stream up to 8 days
after the first injection?
4. Is ZIO-101 useful in reducing my blood cancer?
A series of tests will be taken throughout the study: medical history will be recorded, a
physical exam performed, an electrocardiogram (EKG) (a measurement of your heart activity),
blood tests. The amount of blood taken for these lab tests will equal about 2 1/2
tablespoons. In addition, a urine pregnancy test (if applicable), and a urine sample taken
to test if your kidneys are working correctly. To see the current condition of your blood
cancer, additional tests may need to be performed if they have not already been done
recently. These tests may include: a bone marrow biopsy, special testing of your blood, a CT
scan and a bone scan.
Immediately before being treated with ZIO-101, you will have another physical examination,
you will also be asked about any medicines you are taking and how you are feeling. The
blood tests may need to be repeated along with the EKG and the urine test. In addition, a
small blood sample must be taken immediately before the injection of ZIO-101.
The injections of ZIO-101 will take approximately one hour. Following the first injection
only, you will have 6 samples of blood taken at 0.5, 1, 2, 4, 8 and 12 hours. Additional
blood samples will be taken prior to each dose of ZIO-101 only. You will also have repeat
EKG within one hour after completing the injection. This process will be repeated for 5
Your next visit will be Week 2 and at the onset of this visit, a blood sample will be taken
and you will be asked how you feel. At Weeks 3 and 4, another blood sample will be taken
and you will be asked how you feel.
At the end of Week 4, a new cycle begins. Immediately before being treated with ZIO-101, you
will have a physical examination, you will be asked about any medicines you are taking and
how you are feeling. The blood tests will be repeated along with the EKG and the urine
test. In addition, any test used to measure your blood cancer will be repeated toward the
end of the cycle.
You may receive up to six of these cycles.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
|Austin, Texas 78705|