Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251446
Status:
COMPLETED
Last Update Posted:
2012-05-11
First Post:
2005-11-08
Brief Title:
A Phase II Single Arm Trial of Single-agent Vinflunine as Second-line Treatment of Advanced Non-Small Cell Lung Cancer
Sponsor:
Veeda Oncology
Organization:
Veeda Oncology
Study Overview
Official Title:
A Phase II Single Arm Trial of Single-agent Vinflunine as Second-line Treatment of Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-05
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:
This is a Phase II single-arm study in patients with stage IIIB with malignant pleural effusion and IV NSCLC who have been previously treated with a platinum-based doublet
Each cycle will be 21 days On Day 1 of each cycle patients will receive vinflunine 320 mgm2 as a 20-minute IV infusion
Patients will continue to receive study treatment until disease progression or unacceptable toxicity
Patients will be evaluated every 2 cycles for response using RECIST criteria
Each cycle will be 21 days On Day 1 of each cycle patients will receive vinflunine 320 mgm2 as a 20-minute IV infusion
Patients will continue to receive study treatment until disease progression or unacceptable toxicity
Patients will be evaluated every 2 cycles for response using RECIST criteria
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