Iressa as Second Line Therapy in Advanced NSCLC-Asia

NCT ID: NCT00478049

Last Updated: 2012-06-06

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

PHASE3

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2009-02-28

Brief Summary

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This is a randomized, open-label, parallel group, phase III, multicenter, regional study. The total number of patients expected to be exposed to study procedures is approximately 150 patients will be recruited by investigational sites throughout the Asia Pacific region that have expertise in treating patients with NSCLC.

Detailed Description

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Conditions

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NSCLC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Docetaxel

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

intravenous infusion

2

Gefitinib

Group Type EXPERIMENTAL

Gefitinib

Intervention Type DRUG

250 mg oral tablet

Interventions

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Gefitinib

250 mg oral tablet

Intervention Type DRUG

Docetaxel

intravenous infusion

Intervention Type DRUG

Other Intervention Names

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ZD1839 IRESSA Taxotere

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma.
* WHO Performance status 0-2
* NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
* Life expectancy of 12 weeks.

Exclusion Criteria

* ALT/AST: \>2.5x ULRR if no demonstrable liver metastases or greater than 5 x ULRR in the presence of liver.
* Inadequate bone marrow function; Absolute neutrophil count: \<1.5 x 109/L, Platelets: \< 100 x 109/L
* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma of skin 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

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SangWe Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Research Site

Incheon, , South Korea

Site Status

Research Site

Kyonggi-do, , South Korea

Site Status

Research Site

Seoul, , South Korea

Site Status

Research Site

Suwon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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D7913L00039

Identifier Type: -

Identifier Source: org_study_id

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