Multicentre, open label, extension study of treatment with gefitinib (IRESSA™) for patients completing other gefitinib clinical studies who may benefit from gefitinib treatment

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 533

Inclusion Criteria

1.Provision of informed consent
2.Patients who have completed a preceding gefitinib study and in the opinion of the investigator may benefit from gefitinib treatment. Only patients completing the studies listed below are eligible for enrolment in this open label extension protocol.
1839IL/0709 (250mg dosing)
1839IL/0710 (250mg dosing)
3.No more than 14 days have elapsed between the patient completing the preceding gefitinib clinical study and beginning of this study except when agreed by the AstraZeneca physician.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known severe hypersensitivity to gefitinib or any of the excipients of this product
2.Pregnancy or breast feeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
3.Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
4.In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
5.Withdrawal, at any time, from the preceding gefitinib study.
6.Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John’s Wort
7.Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
8.Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site)
9.Previous enrolment in the present study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to provide, or continue to provide, gefitinib treatment to patients who have recently participated in other gefitinib clinical studies.;Secondary Objective: There are no secondary objectives of the study.;Primary end point(s): There are no endpoints for this study

Secondary Outcome Measures

Name	Time	Method

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