NSCLC Clinical Trial
Official title:
A Double Blind,Placebo Controlled,Parallel Group,Multicentre,Randomised,Phase Iii Survival Study Comparing ZD1839 (IRESSA™)(250mg Tablet) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced NSCLC Who Have Received One Or Two Prior Chemotherapy Regimens And Are Refractory Or Intolerant To Their Most Recent Regimen
| Verified date | April 2009 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This study is being carried out to see if adding ZD1839 to other standard supportive care is more effective than standard supportive care alone for the treatment of patients with NSCLC whose disease has recurred after previous chemotherapy treatment.
| Status | Completed |
| Enrollment | 1692 |
| Est. completion date | April 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - · Life expectancy of at least 8 weeks. - Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma - Not suitable for chemotherapy - WHO Performance status 0,1, 2 or 3 Exclusion Criteria: - Newly diagnosed CNS mets - Less than 1 week since completion of prior radiotherapy or persistence of any radiotherapy related toxicity - ALT/AST greater than 5 x upper limit of normal - ANC less than 1.0 x 109/L or platelets less than 100 x 109/L |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Bahia Blanca | |
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Capital Federal | Buenos Aires |
| Argentina | Research Site | La Plata | |
| Argentina | Research Site | Mar del Plata | |
| Argentina | Research Site | Rosario | |
| Argentina | Research Site | Santa Fe | |
| Australia | Research Site | Ashford | South Australia |
| Australia | Research Site | Chermside | Queensland |
| Australia | Research Site | Concord | New South Wales |
| Australia | Research Site | Melbourne | Victoria |
| Australia | Research Site | Parkville | Victoria |
| Australia | Research Site | Potts Point | New South Wales |
| Australia | Research Site | Prahran | Victoria |
| Australia | Research Site | South Brisbane | Queensland |
| Australia | Research Site | St. Leonards | New South Wales |
| Australia | Research Site | Wodonga | Victoria |
| Australia | Research Site | Woodville | South Australia |
| Australia | Research Site | Woodville South | |
| Brazil | Research Site | Belo Horizonte | MG |
| Brazil | Research Site | Fortaleza | CE |
| Brazil | Research Site | Porto Alegre | RS |
| Brazil | Research Site | Rio de Janeiro | RJ |
| Brazil | Research Site | Sao Paulo | SP |
| Brazil | Research Site | Sorocaba | SP |
| Bulgaria | Research Site | Pleven | |
| Bulgaria | Research Site | Plovdiv | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Stara zagora | |
| Bulgaria | Research Site | Varna | |
| Bulgaria | Research Site | Veliko Tarnovo | |
| Canada | Research Site | Calgary | Alberta |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Laval | Quebec |
| Canada | Research Site | Mississauga | Ontario |
| Canada | Research Site | Monoton | New Brunswick |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Newmarket | Ontario |
| Canada | Research Site | St. Catherines | Ontario |
| Canada | Research Site | Ste-Foy | Quebec |
| Canada | Research Site | Sudbury | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | York | Ontario |
| Chile | Research Site | Various Cities | |
| Estonia | Research Site | Talinn | |
| Estonia | Research Site | Tartu | |
| Germany | Research Site | Bad Segeberg | Schleswig-Holstein |
| Germany | Research Site | Frankfurt | |
| Germany | Research Site | Frankfurt | Hessen |
| Germany | Research Site | Freiburg | |
| Germany | Research Site | Freiburg | Baden-Wurttemberg |
| Germany | Research Site | Gauting | |
| Germany | Research Site | Grobhansdorf | |
| Germany | Research Site | Hamburg | |
| Germany | Research Site | Heidelberg | |
| Germany | Research Site | Heidelberg | Baden-Wurttemberg |
| Germany | Research Site | Hemer | |
| Germany | Research Site | Muchen | |
| Germany | Research Site | Muchen | Bayern |
| Germany | Research Site | Munster | Nordrhein-Westfalen |
| Greece | Research Site | Athens | |
| Greece | Research Site | Heraklion | |
| Greece | Research Site | Marousi | |
| Greece | Research Site | Thessaloniki | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Debrecen | |
| Hungary | Research Site | Deszk | |
| Hungary | Research Site | Kecskemet | |
| Hungary | Research Site | Mosdos | |
| Hungary | Research Site | Mosonmagyarovar | |
| Hungary | Research Site | Pecs | |
| Hungary | Research Site | Szeged | |
| Hungary | Research Site | Torokbalint | |
| Hungary | Research Site | Ujronafj | |
| Hungary | Research Site | Zalaegerszeg | |
| Hungary | Research Site | Zalaegerszeg-Pozva | |
| India | Research Site | India | |
| India | Research Site | Karnataka | |
| India | Research Site | Kolkata | |
| India | Research Site | Vellore | |
| Ireland | Research Site | Beaumont Road | |
| Ireland | Research Site | Cork | |
| Ireland | Research Site | Dooradoyle | Limerick |
| Ireland | Research Site | Dublin 7 | |
| Ireland | Research Site | Dublin 8 | |
| Ireland | Research Site | Elm Park | |
| Latvia | Research Site | Daugavpils | |
| Latvia | Research Site | Liepaja | |
| Latvia | Research Site | Riga | |
| Lithuania | Research Site | Kaunas | |
| Lithuania | Research Site | Vilnius | |
| Malaysia | Research Site | Kuala Lumpur | |
| Malaysia | Research Site | Nilai | |
| Malaysia | Research Site | Penang | |
| Mexico | Research Site | Acapulco | |
| Mexico | Research Site | Durango | |
| Mexico | Research Site | Guadalajara | |
| Mexico | Research Site | Guadalajara | Jalisco |
| Mexico | Research Site | Leon | |
| Mexico | Research Site | Merida | Yucatan |
| Mexico | Research Site | Mexico | |
| Mexico | Research Site | Monterrey | Neuvo Leon |
| Mexico | Research Site | Torreon | Coahuila |
| Netherlands | Research Site | Alkmaar | |
| Netherlands | Research Site | Amsterdam | |
| Netherlands | Research Site | Enschede | |
| Netherlands | Research Site | Groningen | |
| Netherlands | Research Site | Leiden | |
| Netherlands | Research Site | Nieuwegein | |
| Netherlands | Research Site | Rotterdam | |
| Norway | Research Site | Alesund | |
| Norway | Research Site | Bergen | |
| Norway | Research Site | Gjettum | |
| Norway | Research Site | Hamar | |
| Norway | Research Site | Haugesund | |
| Norway | Research Site | Kristiansand | |
| Norway | Research Site | Nordbyhagen | |
| Norway | Research Site | Oslo | |
| Norway | Research Site | Skien | |
| Norway | Research Site | Stavanger | |
| Norway | Research Site | Tromso | |
| Norway | Research Site | Trondheim | |
| Peru | Research Site | Various Cities | |
| Philippines | Research Site | Manila | |
| Philippines | Research Site | Pasig | |
| Philippines | Research Site | Quezon City | |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Katowice | |
| Poland | Research Site | Krakow | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Szczecin | |
| Poland | Research Site | Zabrze | |
| Romania | Research Site | Bucharest | |
| Romania | Research Site | Bucuresti | |
| Romania | Research Site | Cluj Napoca | |
| Romania | Research Site | Craiova | |
| Romania | Research Site | Iasi | |
| Romania | Research Site | Timisoara | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | St. Petersburg | |
| Singapore | Research Site | Singapore | |
| Slovakia | Research Site | Bratislava | |
| Slovakia | Research Site | Dolny Kubin | |
| Slovakia | Research Site | Jilina | |
| Slovakia | Research Site | Kojice | |
| Slovakia | Research Site | Martin | |
| Slovakia | Research Site | Michalovce | |
| Slovakia | Research Site | Nitra | |
| Slovakia | Research Site | Nitra-Zobor | |
| Slovakia | Research Site | Nove Zamky | |
| Slovakia | Research Site | Poprad | |
| Slovakia | Research Site | Poprad - Kvetnica | |
| Slovakia | Research Site | Prejov | |
| Slovakia | Research Site | Trnava | |
| Sweden | Research Site | Goteborg | |
| Sweden | Research Site | Huddinge | |
| Sweden | Research Site | Jonkoping | |
| Sweden | Research Site | Karlstad | |
| Sweden | Research Site | Linkoping | |
| Sweden | Research Site | Lund | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Uppsala | |
| Sweden | Research Site | Vasteras | Vastmanlands Lan |
| Taiwan | Research Site | Kaohsiung | |
| Taiwan | Research Site | Pan-Chiao | Taipei |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Tainan | |
| 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 | Izmir | |
| Ukraine | Research Site | Various Cities | |
| United Kingdom | Research Site | Aberdeen | |
| United Kingdom | Research Site | Belfast | Northern Ireland |
| United Kingdom | Research Site | Birmingham | West Midlands |
| United Kingdom | Research Site | Birmingham | |
| United Kingdom | Research Site | Bradford | |
| United Kingdom | Research Site | Brighton | |
| United Kingdom | Research Site | Cambridge | Cambrideshire |
| United Kingdom | Research Site | Colchester | Essex |
| United Kingdom | Research Site | Coventry | |
| United Kingdom | Research Site | Dundee | |
| United Kingdom | Research Site | Essex | |
| United Kingdom | Research Site | Exeter | Devon |
| United Kingdom | Research Site | Fulwood | Lanc |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | Gorleston | Great Yarmouth |
| United Kingdom | Research Site | Guildford | |
| United Kingdom | Research Site | Gwynedd | |
| United Kingdom | Research Site | Harrogate | |
| United Kingdom | Research Site | Huddersfield | |
| United Kingdom | Research Site | Hull | |
| United Kingdom | Research Site | Lancaster | |
| United Kingdom | Research Site | Leicester | |
| United Kingdom | Research Site | Liverpool | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | Manchester | |
| United Kingdom | Research Site | Newcastle-upon-Tyne | |
| United Kingdom | Research Site | Norwich | Norfolk |
| United Kingdom | Research Site | Nottingham | Northamptonshire |
| United Kingdom | Research Site | Nottingham | |
| United Kingdom | Research Site | Oxford | |
| United Kingdom | Research Site | Reading | |
| United Kingdom | Research Site | Romford | Essex |
| United Kingdom | Research Site | Southampton | |
| United Kingdom | Research Site | Swansea | |
| United Kingdom | Research Site | Wolverhampton | |
| United Kingdom | Research Site | York | |
| Venezuela | Research Site | Various Cities |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Estonia, Germany, Greece, Hungary, India, Ireland, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Romania, Russian Federation, Singapore, Slovakia, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Venezuela,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care | |||
| Secondary | · ZD1839 + BSC versus Placebo + BSC in terms of time to treatment failure | |||
| Secondary | · ZD1839 + BSC versus Placebo + BSC in terms of investigator assessed overall | |||
| Secondary | · objective tumour response (CR + PR) | |||
| Secondary | · ZD1839 + BSC versus Placebo + BSC in terms of tolerability | |||
| Secondary | · ZD1839 + BSC versus Placebo + BSC in terms of quality of life changes |
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