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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00298688

First received: March 1, 2006

Last updated: June 11, 2008

Last verified: June 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

March 1, 2006

Last Updated Date

June 11, 2008

Start Date ^ICMJE

September 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

To determine the disease control rate in these patients

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00298688 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Small Cell Lung Cancer

Intervention ^ICMJE

Drug: Gefitinib

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00298688

Other Study ID Numbers ^ICMJE

1839IL/0559

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

AstraZeneca Iressa Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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