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)”

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 Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• There are no endpoints in this Expanded Access programme. No formal analysis will be performed on any data obtained. All safety data will be tabulated for reporting purposes only.
  • Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Alison Armour Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00684385

Study ID Number: 1839IL/0052

ClinicalTrials.gov Identifier: NCT00684385

Health Authority: China: Ethics Committee