An Expanded Access Programme With Iressa for Patients With Non-Small-Cell Lung Cancer and Cancer of the Head and Neck

March 5, 2019 updated by: AstraZeneca

An International Expanded Access Clinical Programme With ZD1839 (IRESSA) for Patients With Advanced Non-small Cell Lung Cancer(NSCLC) and Patients With Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck (H&NC)

The purpose of this study is to provide ZD1839 for those patients with locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV) or recurrent and/or metastatic squamous cell head and neck cancer who receive the therapy on an expanded access basis due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13125
        • Research Site
      • Berlin, Germany, 10117
        • Research Site
      • Berlin, Germany, 14165
        • Research Site
      • Berlin, Germany, 13189
        • Research Site
      • Essen, Germany, 45122
        • Research Site
      • Frankfurt, Germany, 60590
        • Research Site
      • Freiburg, Germany, 79106
        • Research Site
      • Großhansdorf, Germany, 22927
        • Research Site
      • Göttingen, Germany, 37075
        • Research Site
      • Halle, Germany, 06120
        • Research Site
      • Halle, Germany, 06112
        • Research Site
      • Heidelberg, Germany, 69126
        • Research Site
      • Kiel, Germany, 24105
        • Research Site
      • Laatzen, Germany, 30880
        • Research Site
      • Lemgo, Germany, 32657
        • Research Site
      • Löwenstein, Germany, 74245
        • Research Site
      • Mainz, Germany, 55131
        • Research Site
      • München, Germany, 81675
        • Research Site
      • Nürnberg, Germany, 90419
        • Research Site
      • Oldenburg, Germany, 26121
        • Research Site
      • Oldenburg, Germany, 26133
        • Research Site
      • Stralsund, Germany, 18437
        • Research Site
      • Stuttgart, Germany, 70174
        • Research Site
      • Trier, Germany, 54292
        • Research Site
      • Wiesbaden, Germany, 65199
        • Research Site
  • Hungary
      • Budapest, Hungary, 1121
        • Research Site
      • Budapest, Hungary, 1125
        • Research Site
      • Budapest, Hungary, 1122
        • Research Site
      • Kecskemét, Hungary, 6000
        • Research Site
      • Törökbálint, Hungary, 2045
        • Research Site
  • Poland
      • Gdańsk, Poland, 80-952
        • Research Site
      • Warszawa, Poland, 02-781
        • Research Site
      • Zabrze, Poland, 41-803
        • Research Site
  • United Kingdom
      • Newcastle-upon-Tyne, United Kingdom, NE4 5BE
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have received at least one course of standard systemic chemotherapy or radiation therapy
  • Are ineligible for chemotherapy or radiotherapy
  • Are ineligible or not candidates for enrollment in available ZD1839 trials for NSCLC or squamous cell H&NC
  • Are, in the investigators opinion, not medically suitable for chemotherapy.

Exclusion Criteria:

  • Current eligibility (i.e., meeting the inclusion and exclusion criteria except signed informed consent) for any ZD1839 protocol available to the patient, or previous enrollment in a blinded ZD1839 protocol
  • Patients from a blinded protocol may be considered for acceptance, with AstraZeneca's permission, only after trial completion and unblinding of all patients.
  • Patients eligible for or previously enrolled in an open-label or unblinded ZD1839 clinical trial may be considered for acceptance with AstraZeneca's permission
  • Incomplete healing from prior oncologic or other major surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 21, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (Estimate)

May 26, 2008

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1839IL/0052
  • D7914C00052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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