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

NCT00251446 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2012-05-11

No results posted yet for this study

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

Interventions

DRUG

Vinflunine

320 mg/m2 as a 20-minute IV infusion

Sponsors & Collaborators

Principal Investigators

  • Marcos Joppert, MD · Veeda Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00251446 on ClinicalTrials.gov