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Gefitinib Usage and Outcomes in Routine Treatment

NCT ID: NCT01818947

Last Updated: 2014-01-23

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

Total Enrollment

157 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-11-30

Brief Summary

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The purpose of this study is to understand real world gefitinib usage patterns, patient characteristics and outcomes and to present these for a Caucasian population

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Detailed Description

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A multicentre, retrospective chart review study to characterise gefitinib usage and outcomes in routine treatment

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Gefitinib

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients who received gefitinib first line in the UK Single Payment Access (SPA) scheme
* Locally advanced or metastatic EGFR mutation positive NSCLC
* Supplied with first pack of gefitinib prior to 1st January 2012

Exclusion Criteria

* Patient was treated privately (i.e. outside the NHS)
* Gefitinib was second-line therapy following treatment failure on a prior therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fiona Blackhall, MBCHB FRCP

Role: PRINCIPAL_INVESTIGATOR

The Christie NHS Foundation Trust

Locations

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Queen Elizabeth Hospital

Birmingham, , United Kingdom

Site Status

Velindre Nhs Trust

Cardiff, , United Kingdom

Site Status

Harrogate District Hospital

Harrogate, , United Kingdom

Site Status

Leeds Teaching Hospitals

Leeds, , United Kingdom

Site Status

Liverpool Heart and Chest Hospital

Liverpool, , United Kingdom

Site Status

Mount Vernon Hospital Nhs Trust

London, , United Kingdom

Site Status

Royal Marsden Hospital

London, , United Kingdom

Site Status

University College Hospital

London, , United Kingdom

Site Status

Christie Hospital Nhs Trust

Manchester, , United Kingdom

Site Status

Nottingham University Hospitals Nhs Trust

Nottingham, , United Kingdom

Site Status

Northern General Hospital

Sheffield, , United Kingdom

Site Status

York District Hospital

York, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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NIS-OGB-IRE-2012/1

Identifier Type: -

Identifier Source: org_study_id

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