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NCT00684385 Clinical Trial

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

Non Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT00684385
Other study ID # 1839IL/0052
Secondary ID D7914C00052
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date February 2019
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Germany Research Site Berlin
Germany Research Site Berlin
Germany Research Site Berlin
Germany Research Site Berlin
Germany Research Site Essen
Germany Research Site Frankfurt
Germany Research Site Freiburg
Germany Research Site Göttingen
Germany Research Site Großhansdorf
Germany Research Site Halle
Germany Research Site Halle
Germany Research Site Heidelberg
Germany Research Site Kiel
Germany Research Site Laatzen
Germany Research Site Lemgo
Germany Research Site Löwenstein
Germany Research Site Mainz
Germany Research Site München
Germany Research Site Nürnberg
Germany Research Site Oldenburg
Germany Research Site Oldenburg
Germany Research Site Stralsund
Germany Research Site Stuttgart
Germany Research Site Trier
Germany Research Site Wiesbaden
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Kecskemét
Hungary Research Site Törökbálint
Poland Research Site Gdansk
Poland Research Site Warszawa
Poland Research Site Zabrze
United Kingdom Research Site Newcastle-upon-Tyne

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Germany,  Hungary,  Poland,  United Kingdom, 

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