A Phase II, Open-Label, Non-Randomized, Multicenter, Single Agent Study of Intravenous SDX-102 for the Treatment of Patients With MTAP-Deficient Cancer
- 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
- 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
Masking: Open Label, Primary Purpose: Treatment
Paul A. Meyers, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|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|