Iressa Expanded Access Program (EAP)

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00034879
Collaborator
(none)
627
38

Study Details

Study Description

Brief Summary

A program for patients with non small cell lung cancer who may benefit from Iressa, but cannot enter another clinical trial due to them not being eligible, or for whom no trials are available.

Condition or Disease Intervention/Treatment Phase
  • Drug: ZD1839 (Gefitinib)
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Expanded Access Clinical Program With ZD1839 (IRESSA®) for Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Study Start Date :
Aug 1, 2000
Actual Primary Completion Date :
Oct 1, 2003
Actual Study Completion Date :
Oct 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    For inclusion in this trial, patients must fulfill all of the following criteria:
    • previous documented histologically or cytologically confirmed non-small cell lung cancer;

    • locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV)patients who have received at least one course of standard systemic chemotherapy or radiation therapy or are ineligible for chemotherapy or radiotherapy or are ineligible or not a candidate for enrollment on another ZD1839 trial or who, in the Investigator's opinion, are not medically suitable for chemotherapy.

    • age 18 years or older;

    • written informed consent to participate in the trial.

    Exclusion Criteria

    Any of the following will exclude a patient from entering the trial:
    • receiving concurrent radiotherapy, chemotherapy, or other systemic anti-cancer medication or any other investigational agent. * Non-cytotoxic or hormonal therapies for the adjuvant treatment of cancer or for previously treated cancers may be allowed per AstraZeneca permission;

    • patients eligible for or previously enrolled on a ZD1839 blinded clinical trial protocol. Patients eligible for or previously enrolled on an open-label or unblinded ZD1839 clinical trial may be considered for acceptance into the Expanded Access Program with AstraZeneca permission;

    • having other active malignancies;

    • incomplete healing from previous oncologic or other major surgery;

    • evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial;

    • pregnancy or breast feeding (women of child-bearing potential).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Alabaster Alabama United States
    2 Research Site Anniston Alabama United States
    3 Research Site Birmingham Alabama United States
    4 Research Site Gadsen Alabama United States
    5 Research Site Huntsville Alabama United States
    6 Research Site Montgomery Alabama United States
    7 Research Site Anchorage Alaska United States
    8 Research Site Fairbanks Alaska United States
    9 Research Site Mesa Arizona United States
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    19 Research Site Anaheim California United States
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    626 Research Site Wausau Wisconsin United States
    627 Research Site Cheyenne Wyoming United States

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Iressa Medical Science Director, MD, AstraZeneca

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00034879
    Other Study ID Numbers:
    • 1839IL/0050
    First Posted:
    May 3, 2002
    Last Update Posted:
    Jan 4, 2013
    Last Verified:
    Jan 1, 2013

    Study Results

    No Results Posted as of Jan 4, 2013