Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00063219
Status:
COMPLETED
Last Update Posted:
2009-08-21
First Post:
2003-06-23
Brief Title:
Study Evaluating MAC-321 in Non-small Cell Lung Cancer Refractory to Platinum-based Therapy
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Phase 2 Open-label Study of MAC-321 Administered Intravenously as a Single Agent for the Treatment of Non-small Cell Lung Cancer Refractory to Platinum-based Therapy
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This non-randomized open-label clinical trial is designed to determine safety and clinical activity of a new chemotherapeutic agent MAC-321 when given intravenously to patients with non-small cell lung cancer Clinical activity will be evaluated by determining the percentage of patients with an objective tumor response after treatment with MAC-321 Patients must have been previously treated with a platinum-containing chemotherapy regimen
A total of 96 patients will be enrolled in this trial Eligible patients will receive MAC-321 intravenously every 3 weeks for up to a total of 6 courses of treatment All patients will receive MAC-321 at the same dose MAC-321 is an experimental drug and is not offered outside of this research trial
A total of 96 patients will be enrolled in this trial Eligible patients will receive MAC-321 intravenously every 3 weeks for up to a total of 6 courses of treatment All patients will receive MAC-321 at the same dose MAC-321 is an experimental drug and is not offered outside of this research trial
Detailed Description:
None
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