Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036920
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2002-05-13
Brief Title:
TLK286 in Treating Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study Of TLK286 For The Treatment Of Advanced Non-Small Cell Lung 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 use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of TLK286 in treating patients who have advanced non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of TLK286 in treating patients who have advanced non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the 12-month survival of patients with advanced non-small cell lung cancer treated with TLK286 II Determine the overall survival of patients treated with this drug III Determine the objective response rate duration of objective response time to tumor progression and disease stabilization in patients treated with this drug IV Determine the safety of this drug in these patients
OUTLINE This is a multicenter study Patients receive TLK286 IV over 30 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed every 6 weeks for 1 year and then every 12 weeks thereafter
PROJECTED ACCRUAL Approximately 55 patients will be accrued for this study within 12 months
OUTLINE This is a multicenter study Patients receive TLK286 IV over 30 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed every 6 weeks for 1 year and then every 12 weeks thereafter
PROJECTED ACCRUAL Approximately 55 patients will be accrued for this study within 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-01147 | None | None | None |
| CDR0000069341 | REGISTRY | None | None |
| NCI-G02-2063 | Registry Identifier | PDQ Physician Data Query | None |