A Phase II, Open-Label, Non-Randomized, Multicenter, Single Agent Study of Intravenous SDX-102 for the Treatment of Patients With MTAP-Deficient Cancer
OBJECTIVES:
- Determine the response rates in patients with methylthioadenosine phosphorylase
(MTAP)-deficient cancer when treated with alanosine.
- Determine the time to response and duration of response in patients treated with this
drug.
- Determine the progression-free survival of patients treated with this drug.
- Determine the pharmacodynamic activity of this drug in these patients, based on special
imaging to measure tumor adenosine triphosphate depletion.
- Determine the pharmacokinetic activity of this drug in these patients.
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive alanosine IV continuously on days 1-5. Treatment repeats every 21 days for
up to 9 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 28 days.
PROJECTED ACCRUAL: A total of 50-145 patients (10-29 per tumor type) will be accrued for
this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Paul A. Meyers, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
SALMEDIX-SDX-102-01
NCT00062283
March 2003
December 2009
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville, Tennessee 37232-2516 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
St. Vincent's Comprehensive Cancer Center - Manhattan | New York, New York 10011 |
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center | Los Angeles, California 90048 |
Midwest Cancer Research Group, Incorporated | Skokie, Illinois 60077 |
MD Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Lynn Regional Cancer Center West | Boca Raton, Florida 33428 |
Wilshire Oncology Medical Group, Incorporated - La Verne | La Verne, California 91750 |
U.S. Oncology, Incorporated | Houston, Texas 77060 |