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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
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT00684385
Enrollment
Unknown
Registered
2008-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2019-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGZD1839

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.

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to 130 Years
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

Countries

Germany, Hungary, Poland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026