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Approved for marketing NCT00683306

Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment

Conditions: Non Small Cell Lung Cancer (NSCLC)

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
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 the same dose and regimen of gefitinib established in their preceding study, for as long as the patients continue to derive benefit.
Who can participate
Inclusion Criteria: * 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 Criteria: * 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
Locations 18
Argentina (1)
Research Site
La Plata
Australia (1)
Research Site
Concord
Brazil (1)
Research Site
Fortaleza
Bulgaria (1)
Research Site
Plovdiv
Estonia (1)
Research Site
Tallinn
Hungary (1)
Research Site
Budapest
India (1)
Research Site
Hyderabad
Latvia (1)
Research Site
Daugavpils
Malaysia (1)
Research Site
George Town
Mexico (1)
Research Site
Durango
Philippines (1)
Research Site
Manila
Romania (1)
Research Site
Bucharest
Russia (1)
Research Site
Moscow
Singapore (1)
Research Site
Singapore
South Africa (1)
Research Site
Johannesburg
Taiwan (1)
Research Site
Kaohsiung City
Thailand (1)
Research Site
Bangkok
Turkey (1)
Research Site
Ankara
Technical details
Status
Approved for marketing
Study type
EXPANDED_ACCESS
Sex
Male and female
Minimum age
18 Years
Maximum age
130 Years
Healthy volunteers
No
Registry ID
NCT00683306
Source
anzctr
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