Lung Cancer Clinical Trial
Official title:
A Phase II, Open-Label, Non-Randomized, Multicenter, Single Agent Study of Intravenous SDX-102 for the Treatment of Patients With MTAP-Deficient Cancer
RATIONALE: Drugs used in chemotherapy such as alanosine use different ways to stop tumor
cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well alanosine works in treating patients with
soft tissue sarcoma, sarcoma of the bone, mesothelioma, non-small cell lung cancer, or
pancreatic 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.
;
Masking: Open Label, Primary Purpose: Treatment
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