A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients

CompletadoFase 2ClinicalTrials.gov

ID: NCT00743938Tipo: INTERVENTIONALInicio: 1 de mar de 2009Fin estimado: 1 de jun de 2012

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

ECOG PS of 0 or 1
Histologically confirmed NSCLC
Adequate amount of tumor (archived or fresh) for biomarker evaluation
Received one to two regimens of chemotherapy (with at least one platinum-containing)
Serum creatinine of less than 1.0 mg/dL or a 24 hour creatinine clearance of greater than 60 mL/min
Stable control of blood pressure on agents other than calcium channel blockers
Women of child-bearing potential must avoid pregnancy or maintain adequate contraception
Must be able to swallow pills and take the medications at the same time every day on an empty stomach

Criterios de exclusión

ECOG PS 2 or greater
Women unwilling to avoid pregnancy or use adequate contraception
Symptomatic brain metastases
Recent history of TIA, CVA, or thrombotic/thromboembolic event (within 6 months)
History of hemoptysis greater than 10 mL/day
Significant cardiovascular disease
Uncontrolled diarrhea, Crohn's disease, ulcerative colitis, or any malabsorptive disease
History of use of other TKIs
Uncontrolled hypertension
HIV+

Intervenciones

drug

BMS-690514

Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity

drug

Erlotinib

Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity

Ubicaciones

Local Institution

Bahía Blanca, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

La Plata, Buenos Aires, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

La Rioja, La Rioja Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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