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Iressa Re-Challenge in Advanced NSCLC EGFR M+ Patients Who Responded to Gefitinib USed as 1st Line or Previous Treatment

NCT01530334 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2016-02-23

Study results available
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Summary

the primary objective is to characterise the impact of gefitinib on the Response Evaluation Criteria in Solid Tumours (RECIST) based assessments; objective response rate (ORR ; confirmed complete response(CR) or partial response (PR)) and disease control rate (DCR; confirmed complete response(CR) or partial response (PR) or stable disease (SD)) in patients with EGFR M+ NSCLC

Conditions

Interventions

DRUG

Gefitinib 250mg

Gefitinib 250mg once daily

Sponsors & Collaborators

Principal Investigators

  • Gilberto Riggi, MD MEDICAL DIRECTOR · AstraZeneca SpA, Medical Dept., Basiglio, ITALY

  • Filippo Marinis, MD · S.Camillo-Forlanini High Specialization Hospitals, Rome, ITALY

  • Silvia Ferrari, MD · AstraZeneca SpA, Medical Dept., Basiglio, ITALY

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
2012-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Italy

Study Locations

More Related Trials

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 NCT01530334 on ClinicalTrials.gov