This trial is for patients with advanced non-small cell lung cancer who have completed a preceding gefitinib trial (ZD1839IL0709 or ZD1839IL0710) and in the opinion of the investigator may benefit from gefitinib treatment
Conditions
Interventions
Product Name: Iressa
Product Code: ZD1839
Pharmaceutical Form: Tablet
INN or Proposed INN: gefitinib
Current Sponsor code: D791AC00008
Other descriptive name: Iressa
Concentration unit: mg milligram
Sponsors
AstraZeneca Österreich GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Austria, Hungary, Latvia, Lithuania
Outcome results
None listed