NCT00251446

A Phase II Single Arm Trial of Single-agent Vinflunine as Second-line Treatment of Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Veeda Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 mg/m2 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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Vinflunine	320 mg/m2 as a 20-minute IV infusion

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2005-11-10
• Last updated: 2012-05-11

Locations

1 site across 1 country: United States