Alanosine in Treating Patients With Cancer
A Phase II, Open-Label, Non-Randomized, Multicenter, Single Agent Study of Intravenous SDX-102 for the Treatment of Patients With MTAP-Deficient Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
This PHASE2 trial investigates Lung Cancer and Malignant Mesothelioma and is currently completed. Memorial Sloan Kettering Cancer Center leads this study, which shows 6 recorded versions since 2003 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)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.
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.
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
-
Sep 2024 — Present [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
▶ Show 1 earlier version
-
Jan 2017 — Jun 2018 [monthly]
Completed PHASE2
First recorded
Mar 2003
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Memorial Sloan Kettering Cancer Center
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .