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

NCT ID: NCT00298688

Last Updated: 2008-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-03-31

Brief Summary

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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

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Conditions

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Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gefitinib

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Iressa Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Copenhagen, , Denmark

Site Status

Research Site

Herlev, , Denmark

Site Status

Research Site

Manchester, , United Kingdom

Site Status

Countries

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Denmark United Kingdom

Other Identifiers

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1839IL/0559

Identifier Type: -

Identifier Source: org_study_id