Iressa Expanded Access Program (EAP)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00034879
First received: May 2, 2002
Last updated: January 3, 2013
Last verified: January 2013
  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: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00034879

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

No publications provided

ClinicalTrials.gov Identifier: NCT00034879     History of Changes
Other Study ID Numbers: 1839IL/0050
Study First Received: May 2, 2002
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

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:
Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014