Status:
APPROVED_FOR_MARKETING
Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment
Lead Sponsor:
AstraZeneca
Conditions:
Non Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18-130 years
Brief Summary
The purpose of this study is to provide gefitinib treatment to patients who, on completion or closure of other gefitinib clinical studies, were either receiving placebo treatment, or are continuing on...
Eligibility Criteria
Inclusion
- Patients who have completed preceding gefitinib therapy from either the 1839IL/0709 (250mg dosing) study or 1839IL/0710 (250mg dosing) study and in the opinion of the investigator may benefit from further gefitinib treatment.
- No more than 14 days lapse in gefitinib treatment between the patient completing the preceding gefitinib clinical study and beginning of this study except when agreed by the AstraZeneca physician.
Exclusion
- Any evidence of clinically active interstitial lung disease (patients with chronic,stable, radiographic changes who are asymptomatic need not be excluded).
- 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).
- Withdrawal, at any time, from the preceding gefitinib study.
- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00683306
Last Update
September 13 2018
Active Locations (65)
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1
Research Site
La Plata, Argentina, 1900
2
Research Site
Concord, Australia, 2139
3
Research Site
Graz, Austria, AT-8306
4
Research Site
Linz, Austria, 4020