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Iressa Expanded Access Program (EAP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00034879
First Posted: May 3, 2002
Last Update Posted: January 4, 2013
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.
Information provided by:
AstraZeneca
  Purpose
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 Intervention 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
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Study Start Date: August 2000
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ZD1839 (Gefitinib)
    Other Name: Iressa
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00034879


  Show 627 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Iressa Medical Science Director, MD AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00034879     History of Changes
Other Study ID Numbers: 1839IL/0050
First Submitted: May 2, 2002
First Posted: May 3, 2002
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:
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action