A Study of IRESSA in Relapsed and Refractory Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Small Cell Lung Cancer

• Registration Number: NCT00298688
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to determine the disease control rate at trial closure and after the first stage of the study in patients with relapsed or refractory SCLC and measurable disease treated with gefitinib

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2006-03-01
• Study First Submitted QC: 2006-03-01
• Study First Posted: 2006-03-03
• Study Completion: 2007-03
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-11
• Last Update Posted: 2008-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Provision of written informed consent
• Histologically confirmed, relapsed or refractory SCLCr
• Aged 18 or over and a life expectancy of more than 2 months

Exclusion Criteria

• Any evidence of clinically active interstitial lung disease
• Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the disease control rate in these patients

Secondary Outcome Measures

Name	Time	Method
To determine the objective response rate at trail closure in these patients
To determine the time to progression-or-death in these patients
To determine overall survival in these patients

Trial Locations

Locations (1)

Research Site; 🇬🇧 Manchester, United Kingdom