Iressa in the Treatment of Brain Metastases From Non Small Cell Lung Cancer

This study has been terminated.

(Closed due to insufficient recruitment.)

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00234442

First received: October 5, 2005

Last updated: June 29, 2009

Last verified: June 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 5, 2005

Last Updated Date

June 29, 2009

Start Date ^ICMJE

July 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Disease control rate (complete response, partial response and stable disease)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00234442 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Duration of response
Time to progression
Overall Survival

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

Iressa in the Treatment of Brain Metastases From Non Small Cell Lung Cancer

Official Title ^ICMJE

A Phase II, Multicentre, Non-Comparative, Open-Label Study To Evaluate The Efficacy And Tolerability Of ZD1839 (Iressa™) In Asymptomatic Radio-Naive Patients With Brain Metastases From Non-Small Cell Lung Carcinoma (NSCLC) Who Have Relapsed Following Prior Chemotherapy

Brief Summary

The aim of the study is to determine if Iressa is effective in the treatment of Brain metastases from NCSLC

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

Brain Neoplasms
Non Small Cell Lung Cancer

Intervention ^ICMJE

Drug: Iressa (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

Terminated

Enrollment ^ICMJE

Completion Date

February 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Radiologically confirmed brain metastases from Non Small Cell Lung Cancer
No symptoms due to brain metastases
No previous radiotherapy treatment for the Brain metastases

Exclusion Criteria:

No prior chemotherapy
No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)

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

Italy

Administrative Information

NCT Number ^ICMJE

NCT00234442

Other Study ID Numbers ^ICMJE

1839IL/0569

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Lucio Crino, MD

Bologna, Italy

Information Provided By

AstraZeneca

Verification Date

June 2009

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

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