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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.
ClinicalTrials.gov Identifier: NCT00034879
Recruitment Status : Completed
First Posted : May 3, 2002
Last Update Posted : January 4, 2013
Information provided by:

May 2, 2002
May 3, 2002
January 4, 2013
August 2000
October 2003   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00034879 on ClinicalTrials.gov Archive Site
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Iressa Expanded Access Program (EAP)
An Expanded Access Clinical Program With ZD1839 (IRESSA®) for Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
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.
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Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Carcinoma
  • Non-small-cell Lung
  • Metastases
  • Neoplasm
Drug: ZD1839 (Gefitinib)
Other Name: Iressa
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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October 2003
October 2003   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Study Director: Iressa Medical Science Director, MD AstraZeneca
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP