Iressa Expanded Access Program (EAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00034879
Recruitment Status : Completed
First Posted : May 3, 2002
Last Update Posted : January 4, 2013
Information provided by:

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
Carcinoma Non-small-cell Lung Metastases Neoplasm Drug: ZD1839 (Gefitinib) Phase 3

AstraZeneca has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type : Interventional  (Clinical Trial)
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 : August 2000
Actual Primary Completion Date : October 2003
Actual Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib
U.S. FDA Resources

Intervention Details:
    Drug: ZD1839 (Gefitinib)
    Other Name: Iressa

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00034879

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Sponsors and Collaborators
Study Director: Iressa Medical Science Director, MD AstraZeneca Identifier: NCT00034879     History of Changes
Other Study ID Numbers: 1839IL/0050
First Posted: May 3, 2002    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013

Keywords provided by AstraZeneca:
Locally advanced and/or metastatic non-operable
non-small cell lung cancer (stage III or IV)
patients who have failed standard therapy.

Additional relevant MeSH terms:
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action