Working… Menu

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

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: NCT00684385
Expanded Access Status : Approved for marketing
First Posted : May 26, 2008
Last Update Posted : March 14, 2019
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Cancer of the Head and Neck Drug: ZD1839

Layout table for study information
Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: 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)

Intervention Details:
  • Drug: ZD1839
    250mg administered daily for patients with NSCLC and500mg daily for patients with H&NC. Treatment dispensed to patients on Day 1 and every 12 weeks thereafter until the patient withdraws. Patients with NSCLC will take one tablet at each dose administration; patients with squamous cell H&NC will take two tablets at each dose administration.
    Other Name: Iressa

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00684385

Layout table for location information
Research Site
Berlin, Germany, 10117
Research Site
Berlin, Germany, 13125
Research Site
Berlin, Germany, 13189
Research Site
Berlin, Germany, 14165
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, 06112
Research Site
Halle, Germany, 06120
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
Budapest, Hungary, 1121
Research Site
Budapest, Hungary, 1122
Research Site
Budapest, Hungary, 1125
Research Site
Kecskemét, Hungary, 6000
Research Site
Törökbálint, Hungary, 2045
Research Site
Gdańsk, Poland, 80-952
Research Site
Warszawa, Poland, 02-781
Research Site
Zabrze, Poland, 41-803
United Kingdom
Research Site
Newcastle-upon-Tyne, United Kingdom, NE4 5BE
Sponsors and Collaborators
Layout table for investigator information
Study Director: Yuri Rukazenkov AstraZeneca
Layout table for additonal information
Responsible Party: AstraZeneca Identifier: NCT00684385    
Other Study ID Numbers: 1839IL/0052
First Posted: May 26, 2008    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Head and Neck Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action