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Study of Gefitinib Retreatment in Non-Small Cell Lung Cancer (NSCLC)

NCT00824746 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2013-02-26

Study results available
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Summary

A single arm, open label, prospective, phase II trial of Gefitinib retreatment for the advanced or metastatic (IIIb and IV) NSCLC patients who previously responded to gefitinib And progressive disease should be observed with at least one prior regimen following previous gefitinib failure.

Primary endpoint

* to assess Disease Control Rate (Remission + Stable disease)

Secondary endpoints

* to assess the progression free survival

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Gefitinib retreatment

phase II trial of Gefitinib retreatment for the advanced or metastatic (IIIb and IV) NSCLC patients who previously responded to gefitinib And progressive disease should be observed with at least one prior regimen following previous EGFR-TKI failure.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Chonnam National University Hospital

    lead OTHER

Principal Investigators

  • Young-Chul Kim, MD, PhD · Chonnam National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-06-30
Completion
2011-12-31

Countries

  • South Korea

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Entities

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 NCT00824746 on ClinicalTrials.gov