Iressa Follow-up Trial

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Lung Cancer

Treatments: Drug: Gefitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00357734

D7913L00008

1839IL/0555

Details and patient eligibility

About

The purpose of this study is to assess the long-term safety profile and the secondary objective to estimate clinical benefit of ZD1839 (gefitinib).

Enrollment: 14 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of written informed consent to participate in the trial.
• Female or male aged 18 years and over.
• Patients with previously diagnosed cancer who have been treated with ZD1839 in a parent ZD1839 clinical trial and may benefit from continuation

Exclusion criteria

• Known severe hypersensitivity to ZD1839
• Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
• Withdrawal from a parent ZD1839 trial because of tumor progress

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Gefitinib (ZD1839)

Experimental group

Description:

ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial

Treatment:

Drug: Gefitinib