Phase I/II Study of Sorafenib and 5-Azacitidine for the Treatment of Patients With Refractory or Relapsed Acute Leukemia and Myelodysplastic Syndrome (MDS) - (VZ-MDS-PI-0227)
The Study Drugs:
Sorafenib is designed to block the function of important proteins in cancer cells. These
proteins, when active, are partly responsible for the abnormal growth and behavior of cancer
cells.
5-Azacytidine is designed to activate ("turn on") certain genes in cancer cells whose job is
to fight tumors.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive 5-azacytidine
either under the skin or by vein on Days 1-7 of each 28-day cycle. If by vein, the infusion
will take about 10-40 minutes.
You will take sorafenib by mouth 2 times a day about 12 hours apart, with water on empty
stomach, every day.
Each study cycle may last a little longer than 28 days, depending on how you are doing.
Study Visits:
Every week, blood (about 1 tablespoon) will be drawn for routine tests.
Every week for the first 6 weeks, and then as often as your doctor thinks it is needed, you
will have your blood pressure measured.
Before each cycle:
- Your performance status will be recorded.
- You will have a physical exam, including measurement of your blood pressure and weight.
Before every 2-4 cycles, you will have a bone marrow aspirate to check the status of the
disease.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drugs if the disease gets worse or
intolerable side effects occur.
Your participation on the study will be over once you have completed the end-of-treatment
and follow-up visits.
End of Study Drug Administration Visit:
After you have stopped taking the study drugs, the following tests and procedures will be
performed:
- Your medical history will be recorded.
- Your performance status will be recorded.
- You will have a physical exam, including measurement of your blood pressure and weight.
- You will have a bone marrow aspirate collected to check the status of disease.
This is an investigational study. Sorafenib is FDA approved and commercially available for
kidney cancer and liver cancer. 5-Azacitidine is FDA approved for the treatment of MDS, but
its combination with sorafenib is investigational.
Up to 60 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
Phase I: Maximum Tolerated Dose (MTD) of AZA + Sorafenib
MTD is defined as highest dose level in which 6 patients treated with at most 1 experiencing a dose limiting toxicity (DLT) during 1st cycle. One cycle of therapy is 7 days of azacitidine (AZA) and 28 days of sorafenib.
Every 28 day cycle
Yes
Farhad Ravandi-Kashani, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2010-0511
NCT01254890
January 2011
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |