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Efficacy, Safety, Tolerabilit...

Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC

NCT ID: NCT01203917

Last Updated: 2017-01-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1060 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2016-06-30

Brief Summary

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This study is carried out to see how Caucasian patients with lung cancer which has EGFR mutation will respond to gefitinib (IRESSA™) as a first line treatment. Safety data will also be collected and analysed to confirm that treatment with gefitinib is safe and well tolerated.

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Detailed Description

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An Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as First line Treatment in Caucasian Patients, who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Conditions

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Caucasian Patients With EGFR Mutation Positive Advanced NSCLC

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

gefitinib 250mg tablet

Group Type OTHER

Gefitinib

Intervention Type DRUG

250mg tablet oral, once daily until objective disease progression is documented or until other discontinuation criterion is met

Interventions

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Gefitinib

250mg tablet oral, once daily until objective disease progression is documented or until other discontinuation criterion is met

Intervention Type DRUG

Other Intervention Names

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IRESSA™

Eligibility Criteria

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Inclusion Criteria

* Locally advanced or metastatic non-small cell lung cancer (i.e. cancer that has spread from where it started) which is EGFR mutation positive
* Caucasian female or male patients aged 18 years or over
* Measurable disease, i.e. at least one lesion, not previously irradiated, as ≥ 10 mm in the longest diameter (≥ 15 mm in short axis for lymph node )

Exclusion Criteria

* Prior adjuvant chemotherapy or other systemic anti-cancer treatment less than 6 month, or palliative radiotherapy less than 4 weeks prior to start of study treatment.
* Brain metastases or spinal cord compression, unless treated and stable without steroids
* Any clinically significant illness, which will jeopardize the patients' safety and their participation in the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers