NCT00684385

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)

• Status: Approved For Marketing
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer
• Cancer of the Head and Neck

Interventions

Type	Name	Description
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.

Timeline

• First posted: 2008-05-26
• Last updated: 2019-03-14

Locations

34 sites across 4 countries: Germany, Hungary, Poland, United Kingdom