Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022243
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2001-08-10
Brief Title:
T138067 in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Has Not Responded to Previous Chemotherapy
Sponsor:
Tularik
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Open Label Study Of T138067-Sodium In A Second-Line Setting In Non-Small-Cell Lung Cancer Patients With Locally Advanced Or Metastatic Disease Who Have Failed First-Line Therapy With a Taxane
Status:
UNKNOWN
Status Verified Date:
2002-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 T138067 in treating patients who have locally advanced or metastatic non-small cell lung cancer that has not responded to previous chemotherapy
PURPOSE Phase II trial to study the effectiveness of T138067 in treating patients who have locally advanced or metastatic non-small cell lung cancer that has not responded to previous chemotherapy
Detailed Description:
OBJECTIVES I Determine the objective tumor response rate in patients with locally advanced or metastatic non-small cell lung cancer who have failed first-line therapy with a taxane when treated with T138067 sodium II Determine the qualitative and quantitative toxic effects of this drug in these patients III Determine the number of patients who progress when treated with this drug IV Determine the duration of response time to disease progression and median survival of patients treated with this drug V Correlate the toxic effects of this drug with peak plasma levels in this patient population
OUTLINE This is a multicenter study Patients receive T138067 sodium IV over 3 hours on days 1 8 and 15 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months after study completion
PROJECTED ACCRUAL A total of 20-35 patients will be accrued for this study within 9 months
OUTLINE This is a multicenter study Patients receive T138067 sodium IV over 3 hours on days 1 8 and 15 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months after study completion
PROJECTED ACCRUAL A total of 20-35 patients will be accrued for this study within 9 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 |
|---|---|---|---|
| TULA-T2002 | None | None | None |
| VU-000511 | None | None | None |