Non Small Cell Lung Cancer (NSCLC) Clinical Trial
Official title:
Multicentre, Open Label, Extension Study of Treatment With Gefitinib(IRESSA™) for Patients Completing Other Gefitinib Clinical Studies Who May Benefit From Gefitinib Treatment
| NCT number | NCT00683306 |
| Other study ID # | D791AC00008 |
| Secondary ID | |
| Status | Approved for marketing |
| Phase | |
| First received | |
| Last updated |
| Verified date | August 2018 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Expanded Access |
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.
| Status | Approved for marketing |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 130 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | La Plata | |
| Australia | Research Site | Concord | |
| Austria | Research Site | Graz | |
| Austria | Research Site | Linz | |
| Austria | Research Site | Wien | |
| Brazil | Research Site | Fortaleza | |
| Brazil | Research Site | Porto Alegre | |
| Brazil | Research Site | Rio de Janeiro | |
| Brazil | Research Site | Sao Paulo | |
| Brazil | Research Site | Sao Paulo | |
| Brazil | Research Site | Sorocaba | |
| Bulgaria | Research Site | Plovdiv | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Varna | |
| Bulgaria | Research Site | Veliko Tarnovo | |
| Estonia | Research Site | Tallinn | |
| Estonia | Research Site | Tartu | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Deszk | |
| Hungary | Research Site | Mosdós | |
| Hungary | Research Site | Pécs | |
| Hungary | Research Site | Zalaegerszeg | |
| India | Research Site | Hyderabad | |
| India | Research Site | Karnataka | |
| India | Research Site | Kolkata | |
| India | Research Site | Mumbai | |
| India | Research Site | New Delhi | |
| India | Research Site | Pune | |
| India | Research Site | Vellore | |
| Latvia | Research Site | Daugavpils | |
| Latvia | Research Site | Riga | |
| Malaysia | Research Site | Kuala Lumpur | |
| Malaysia | Research Site | Nilai | |
| Malaysia | Research Site | Penang | |
| Malaysia | Research Site | Penang | |
| Malaysia | Research Site | Penang | |
| Mexico | Research Site | Durango | |
| Mexico | Research Site | Mexico Distrito Federal | |
| Mexico | Research Site | Monterrey | |
| Mexico | Research Site | Torreon | |
| Philippines | Research Site | Manila | |
| Philippines | Research Site | Pasig | |
| Philippines | Research Site | Quezon City | |
| Philippines | Research Site | Quezon City | |
| Romania | Research Site | Bucharest | |
| Romania | Research Site | Iasi | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Singapore | Research Site | Singapore | |
| South Africa | Research Site | Johannesburg | |
| Taiwan | Research Site | Kaohsiung | |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Tainan | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Tao-Yuan | |
| Thailand | Research Site | Bangkok | |
| Thailand | Research Site | Chiang Mai | |
| Turkey | Research Site | Ankara | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Istanbul |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Argentina, Australia, Austria, Brazil, Bulgaria, Estonia, Hungary, India, Latvia, Malaysia, Mexico, Philippines, Romania, Russian Federation, Singapore, South Africa, Taiwan, Thailand, Turkey,
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