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)
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer (NSCLC), Cancer of the Head and Neck (H&N)
Both
Non Small Cell Lung Cancer (NSCLC), Cancer of the Head and Neck (H&N)
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
There are no endpoints
Safety Issue:
No
Principal Investigator
Alison Armour
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
China: Ethics Committee
Study ID:
1839IL/0052
NCT ID:
NCT00684385
Start Date:
August 2001
Completion Date:
December 2012
Related Keywords:
- Non Small Cell Lung Cancer (NSCLC)
- Cancer of the Head and Neck (H&N)
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
- Lung Neoplasms
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