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Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment

Sponsor
AstraZeneca (Industry)
Overall Status
Approved for marketing
CT.gov ID
NCT00683306
Collaborator
(none)
65
Locations

Study Details

Study Description

Brief Summary

The purpose of this study is to provide gefitinib treatment to patients who, on completion or closure of other gefitinib clinical studies, were either receiving placebo treatment, or are continuing on the same dose and regimen of gefitinib established in their preceding study, for as long as the patients continue to derive benefit.

Condition or Disease Intervention/Treatment Phase
  • Drug: ZD1839 (Iressa)

Study Design

Study Type:
Expanded Access
Official Title:
Multicentre, Open Label, Extension Study of Treatment With Gefitinib(IRESSA™) for Patients Completing Other Gefitinib Clinical Studies Who May Benefit From Gefitinib Treatment

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 130 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients who have completed preceding gefitinib therapy from either the 1839IL/0709 (250mg dosing) study or 1839IL/0710 (250mg dosing) study and in the opinion of the investigator may benefit from further gefitinib treatment.

    • No more than 14 days lapse in gefitinib treatment between the patient completing the preceding gefitinib clinical study and beginning of this study except when agreed by the AstraZeneca physician.

    Exclusion Criteria:

    • Any evidence of clinically active interstitial lung disease (patients with chronic,stable, radiographic changes who are asymptomatic need not be excluded).

    • In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).

    • Withdrawal, at any time, from the preceding gefitinib study.

    • Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site La Plata Argentina 1900
    2 Research Site Concord Australia 2139
    3 Research Site Graz Austria AT-8306
    4 Research Site Linz Austria 4020
    5 Research Site Wien Austria 1140
    6 Research Site Fortaleza Brazil :60431-970
    7 Research Site Porto Alegre Brazil 90610-000
    8 Research Site Rio de Janeiro Brazil 20230-130
    9 Research Site Sao Paulo Brazil 01221-020
    10 Research Site Sao Paulo Brazil 01420-000
    11 Research Site Sorocaba Brazil 18030-200
    12 Research Site Plovdiv Bulgaria 4000
    13 Research Site Sofia Bulgaria 1233
    14 Research Site Sofia Bulgaria 1527
    15 Research Site Sofia Bulgaria 1756
    16 Research Site Varna Bulgaria 9000
    17 Research Site Veliko Tarnovo Bulgaria 5000
    18 Research Site Tallinn Estonia 11619
    19 Research Site Tartu Estonia 51003
    20 Research Site Budapest Hungary 1529
    21 Research Site Deszk Hungary 6772
    22 Research Site Mosdós Hungary 7257
    23 Research Site Pécs Hungary 7635
    24 Research Site Zalaegerszeg Hungary 8900
    25 Research Site Hyderabad India 500082
    26 Research Site Karnataka India
    27 Research Site Kolkata India 700054
    28 Research Site Mumbai India 400012
    29 Research Site New Delhi India 110 085
    30 Research Site Pune India 411001
    31 Research Site Vellore India 632004
    32 Research Site Daugavpils Latvia LV-5420
    33 Research Site Riga Latvia LV-1002
    34 Research Site Kuala Lumpur Malaysia 50590
    35 Research Site Nilai Malaysia
    36 Research Site Penang Malaysia 10990
    37 Research Site Penang Malaysia 11200
    38 Research Site Penang Malaysia
    39 Research Site Durango Mexico 34037
    40 Research Site Mexico Distrito Federal Mexico 06720
    41 Research Site Monterrey Mexico 64320
    42 Research Site Torreon Mexico 27000
    43 Research Site Manila Philippines 1000
    44 Research Site Pasig Philippines
    45 Research Site Quezon City Philippines 1104
    46 Research Site Quezon City Philippines
    47 Research Site Bucharest Romania 022322
    48 Research Site Iasi Romania
    49 Research Site Moscow Russian Federation 115478
    50 Research Site Moscow Russian Federation 121356
    51 Research Site Singapore Singapore 169610
    52 Research Site Johannesburg South Africa 2193
    53 Research Site Kaohsiung Taiwan 807
    54 Research Site Taichung Taiwan 40705
    55 Research Site Tainan Taiwan 704
    56 Research Site Taipei Taiwan 100
    57 Research Site Taipei Taiwan 112
    58 Research Site Taipei Taiwan 11490
    59 Research Site Taipei Taiwan
    60 Research Site Tao-Yuan Taiwan 333
    61 Research Site Bangkok Thailand 10400
    62 Research Site Chiang Mai Thailand 50200
    63 Research Site Ankara Turkey
    64 Research Site Istanbul Turkey 34030
    65 Research Site İstanbul Turkey

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Yuri Rukazenkov, AstraZeneca

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00683306
    Other Study ID Numbers:
    • D791AC00008
    First Posted:
    May 23, 2008
    Last Update Posted:
    Sep 13, 2018
    Last Verified:
    Aug 1, 2018
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Gefitinib

    Study Results

    No Results Posted as of Sep 13, 2018