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Iressa 2nd Line Phase III Study in Japan

NCT ID: NCT00252707

Last Updated: 2007-12-18

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

484 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2006-11-30

Brief Summary

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In this study, among the patients with non-small cell lung cancer, those with metastasis or recurrence and previous treatment with chemotherapy will receive gefitinib or docetaxel, and we will compare the effectiveness and safety of gefitinib with docetaxel.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gefitinib or Docetaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* You are "histologically" or "cytologically" confirmed to have recurrent or metastatic NSCLC
* You have been treated with chemotherapy including platinums for NSCLC.

Exclusion Criteria

* You have received treatment for non-small lung cancer within 4 weeks before your participation in this study (except for specific therapies)
* You have or had any disease of acute lung injury, idiopathic pulmonary fibrosis, pulmonary pneumonia, or pneumoconiosis evident on the X-ray
* You have or had any disease of radiation pneumonia or drug-induced pneumonia, which requires treatment with corticosteroids
Minimum Eligible Age

20 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 Japan Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Nagoya, Aichi-ken, Japan

Site Status

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Okazaki, Aichi-ken, Japan

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Hirosaki, Aomori, Japan

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Kashiwa, Chiba, Japan

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Matsuyama, Ehime, Japan

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Fukuoka, Fukuoka, Japan

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Gifu, Gifu, Japan

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Asahikawa, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Akashi, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Naka-gun, Ibaraki, Japan

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Isehara, Kanagawa, Japan

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Sagamihara, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Kumamoto, Kumamoto, Japan

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Sendai, Miyagi, Japan

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Nagasaki, Nagasaki, Japan

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Ōmura, Nagasaki, Japan

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Niigata, Niigata, Japan

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Beppu, Oita Prefecture, Japan

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Okayama, Okayama-ken, Japan

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Habikino, Osaka, Japan

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Izumisano, Osaka, Japan

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Osaka, Osaka, Japan

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Sakai, Osaka, Japan

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Sayama, Osaka, Japan

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Toyonaka, Osaka, Japan

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Iwata, Shizuoka, Japan

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Sunto-gun, Shizuoka, Japan

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Bunkyo-ku, Tokyo, Japan

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Chūō, Tokyo, Japan

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Kiyose, Tokyo, Japan

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Minato-ku, Tokyo, Japan

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Shinjuku, Tokyo, Japan

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Sumida City, Tokyo, Japan

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Toshima-ku, Tokyo, Japan

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Yamagata, Yamagata, Japan

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Ube, Yamaguchi, Japan

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Kanazawa, , Japan

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Countries

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Japan

References

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Maruyama R, Nishiwaki Y, Tamura T, Yamamoto N, Tsuboi M, Nakagawa K, Shinkai T, Negoro S, Imamura F, Eguchi K, Takeda K, Inoue A, Tomii K, Harada M, Masuda N, Jiang H, Itoh Y, Ichinose Y, Saijo N, Fukuoka M. Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer. J Clin Oncol. 2008 Sep 10;26(26):4244-52. doi: 10.1200/JCO.2007.15.0185.

Reference Type DERIVED
PMID: 18779611 (View on PubMed)

Other Identifiers

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V-15-32

Identifier Type: -

Identifier Source: secondary_id

D791AL00001

Identifier Type: -

Identifier Source: org_study_id