Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062283
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2003-06-05
Brief Title:
Alanosine in Treating Patients With Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000304677 | REGISTRY | PDQ Physician Data Query | None |
| MSKCC-03029 | None | None | None |