An Expanded Access Programme With Iressa for Patients With Non-Small-Cell Lung Cancer and Cancer of the Head and Neck
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)
2 other identifiers
expanded_access
N/A
4 countries
34
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.
Trial Health
Trial Health Score
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34 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2008
CompletedFirst Posted
Study publicly available on registry
May 26, 2008
CompletedMarch 14, 2019
February 1, 2019
May 21, 2008
March 5, 2019
Conditions
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (34)
Research Site
Berlin, 10117, Germany
Research Site
Berlin, 13125, Germany
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Berlin, 13189, Germany
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Berlin, 14165, Germany
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Essen, 45122, Germany
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Frankfurt, 60590, Germany
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Freiburg im Breisgau, 79106, Germany
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Göttingen, 37075, Germany
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Großhansdorf, 22927, Germany
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Halle, 06112, Germany
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Halle, 06120, Germany
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Heidelberg, 69126, Germany
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Kiel, 24105, Germany
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Laatzen, 30880, Germany
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Lemgo, 32657, Germany
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Löwenstein, 74245, Germany
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Mainz, 55131, Germany
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München, 81675, Germany
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Nuremberg, 90419, Germany
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Oldenburg, 26121, Germany
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Oldenburg, 26133, Germany
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Stralsund, 18437, Germany
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Stuttgart, 70174, Germany
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Trier, 54292, Germany
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Wiesbaden, 65199, Germany
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Budapest, 1121, Hungary
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Budapest, 1122, Hungary
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Budapest, 1125, Hungary
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Kecskemét, 6000, Hungary
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Törökbálint, 2045, Hungary
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Gdansk, 80-952, Poland
Research Site
Warsaw, 02-781, Poland
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Zabrze, 41-803, Poland
Research Site
Newcastle upon Tyne, NE4 5BE, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yuri Rukazenkov
AstraZeneca