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Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC

NCT01203917 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1060

Last updated 2017-01-02

Study results available
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Summary

This study is carried out to see how Caucasian patients with lung cancer which has EGFR mutation will respond to gefitinib (IRESSA™) as a first line treatment. Safety data will also be collected and analysed to confirm that treatment with gefitinib is safe and well tolerated.

Conditions

  • Caucasian Patients With EGFR Mutation Positive Advanced NSCLC

Interventions

DRUG

Gefitinib

250mg tablet oral, once daily until objective disease progression is documented or until other discontinuation criterion is met

Sponsors & Collaborators

Principal Investigators

  • Haiyi Jiang · AstraZeneca

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-08-31
Completion
2016-06-30

Countries

  • Bulgaria
  • France
  • Greece
  • Hungary
  • Italy
  • Norway
  • Poland
  • Portugal
  • Romania
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

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 NCT01203917 on ClinicalTrials.gov