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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00242801Tipo: INTERVENTIONALInicio: 1 de jul de 2003Fin estimado: 1 de abr de 2005

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

· 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

Criterios de exclusión

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

Intervenciones

drug

Gefitinib

Ubicaciones

Research Site

Capital Federal, Buenos Aires, Argentina

Research Site

Bahía Blanca, Argentina

Research Site

Buenos Aires, Argentina

Research Site

La Plata, Argentina

Research Site

Mar del Plata, Argentina

Research Site

Rosario, Argentina

Research Site

Santa Fe, Argentina

Patrocinadores

PrincipalAstraZeneca

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