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

June 11, 2008 updated by: AstraZeneca

Phase II Study of Iressa in Relapsed and Refractory Small Cell Lung Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Research Site
      • Herlev, Denmark
        • Research Site
  • United Kingdom
      • Manchester, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the disease control rate in these patients

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Iressa Medical Science Director, MD, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

March 1, 2006

First Submitted That Met QC Criteria

March 1, 2006

First Posted (Estimate)

March 3, 2006

Study Record Updates

Last Update Posted (Estimate)

June 12, 2008

Last Update Submitted That Met QC Criteria

June 11, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1839IL/0559

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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