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An Expanded Access Programme With Iressa for Patients With Non-Small-Cell Lung Cancer and Cancer of the Head and Neck

Sponsor
AstraZeneca (Industry)
Overall Status
Approved for marketing
CT.gov ID
NCT00684385
Collaborator
(none)
34
Locations

Study Details

Study Description

Brief Summary

The purpose of this study is to provide ZD1839 for those patients with locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV) or recurrent and/or metastatic squamous cell head and neck cancer who receive the therapy on an expanded access basis due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access
Official Title:
An International Expanded Access Clinical Programme With ZD1839 (IRESSA) for Patients With Advanced Non-small Cell Lung Cancer(NSCLC) and Patients With Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck (H&NC)

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:

    • Have received at least one course of standard systemic chemotherapy or radiation therapy

    • Are ineligible for chemotherapy or radiotherapy

    • Are ineligible or not candidates for enrollment in available ZD1839 trials for NSCLC or squamous cell H&NC

    • Are, in the investigators opinion, not medically suitable for chemotherapy.

    Exclusion Criteria:

    • Current eligibility (i.e., meeting the inclusion and exclusion criteria except signed informed consent) for any ZD1839 protocol available to the patient, or previous enrollment in a blinded ZD1839 protocol

    • Patients from a blinded protocol may be considered for acceptance, with AstraZeneca's permission, only after trial completion and unblinding of all patients.

    • Patients eligible for or previously enrolled in an open-label or unblinded ZD1839 clinical trial may be considered for acceptance with AstraZeneca's permission

    • Incomplete healing from prior oncologic or other major surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Berlin Germany 10117
    2 Research Site Berlin Germany 13125
    3 Research Site Berlin Germany 13189
    4 Research Site Berlin Germany 14165
    5 Research Site Essen Germany 45122
    6 Research Site Frankfurt Germany 60590
    7 Research Site Freiburg Germany 79106
    8 Research Site Großhansdorf Germany 22927
    9 Research Site Göttingen Germany 37075
    10 Research Site Halle Germany 06112
    11 Research Site Halle Germany 06120
    12 Research Site Heidelberg Germany 69126
    13 Research Site Kiel Germany 24105
    14 Research Site Laatzen Germany 30880
    15 Research Site Lemgo Germany 32657
    16 Research Site Löwenstein Germany 74245
    17 Research Site Mainz Germany 55131
    18 Research Site München Germany 81675
    19 Research Site Nürnberg Germany 90419
    20 Research Site Oldenburg Germany 26121
    21 Research Site Oldenburg Germany 26133
    22 Research Site Stralsund Germany 18437
    23 Research Site Stuttgart Germany 70174
    24 Research Site Trier Germany 54292
    25 Research Site Wiesbaden Germany 65199
    26 Research Site Budapest Hungary 1121
    27 Research Site Budapest Hungary 1122
    28 Research Site Budapest Hungary 1125
    29 Research Site Kecskemét Hungary 6000
    30 Research Site Törökbálint Hungary 2045
    31 Research Site Gdańsk Poland 80-952
    32 Research Site Warszawa Poland 02-781
    33 Research Site Zabrze Poland 41-803
    34 Research Site Newcastle-upon-Tyne United Kingdom NE4 5BE

    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:
    NCT00684385
    Other Study ID Numbers:
    • 1839IL/0052
    • D7914C00052
    First Posted:
    May 26, 2008
    Last Update Posted:
    Mar 14, 2019
    Last Verified:
    Feb 1, 2019
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Head and Neck Neoplasms
    Gefitinib

    Study Results

    No Results Posted as of Mar 14, 2019