Resumen

El propósito del estudio es determinar si sorafenib más el mejor tratamiento de soporte (es decir, además de los tratamientos no oncológicos que los pacientes normalmente recibirían) es un tratamiento eficaz para el cáncer de pulmón en comparación con el mejor tratamiento de soporte solo. También se comparará la seguridad y tolerabilidad de los dos grupos de tratamiento. El objetivo del estudio es evaluar la capacidad de sorafenib para mejorar la supervivencia en comparación con el mejor tratamiento de soporte solo.

Descripción detallada

Acrónimos utilizados en la sección de eventos adversos: coagulación intravascular diseminada (CID), razón internacional normalizada (INR), auriculoventricular (AV), gastrointestinal (GI), no especificado de otra manera (NOS), Criterios de Terminología Común para Eventos Adversos (CTCAE), recuento absoluto de neutrófilos (ANC), sistema nervioso central (SNC), síndrome de dificultad respiratoria aguda (ARDS), alanina aminotransferasa (ALT), aspartato aminotransferasa (AST).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Ability to understand and willingness to sign a written Informed Consent
Advanced relapsed or refractory predominantly non squamous NSCLC. The diagnosis must have been confirmed cyto-/ histologically
Patients must have measurable or non-measurable disease
At least two but not more than three prior standard treatment regimens for NSCLC
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Male or female subjects \>/= 18 years of age (\>/=20 for Japan) at the time of Informed Consent
Life expectancy of at least 12 weeks
Ability to swallow oral medication
Both men and women using adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of the study drug:
Haemoglobin \> 9.0 g/dl
Absolute neutrophil count (ANC) \>1,500/mm3
Platelet count \>/= 100,000/µl
Total bilirubin \</=1.5 x the upper limit of normal
Alanine aminotransferase (ALT) \< 2.5 x upper limit of normal (\</= 5 x upper limit of normal in patients with liver metastases) Aspartate aminotransferase (AST) \< 2.5 x upper limit of normal (\</= 5 x upper limit of normal in patients with liver metastases)
Alkaline phosphatase \< 4 x upper limit of normal (\</= 5 x upper limit of normal in patients with liver metastases)
Prothrombin Time (PT)-International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) \< 1.5 x upper limit of normal
Serum creatinine \< 1.5 x upper limit of normal
Calculated creatinine clearance of \>/= 50 mL/min

Criterios de exclusión

NSCLC patients with predominantly squamous cell carcinoma histology
Excluded medical conditions:
History of cardiac disease: Congestive heart failure, Active coronary artery disease (CAD), Cardiac arrhythmias (\>Grade 2 NCI-CTCAE \[National Cancer Institute-Common Terminology Criteria for Adverse Events\] vers. 3.0)
Uncontrolled hypertension despite two anti-hypertensive medications
History of Human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
History of organ allograft
Active clinically serious infections (\> grade 2 NCI-CTCAE vers. 3.0)
Patients with seizure disorder requiring medication
Patients with evidence or history of bleeding diathesis or coagulopathy
Patients undergoing renal dialysis
Pulmonary hemorrhage/ bleeding event \>/= CTCAE grade 2 within four weeks prior to the first dose of the study drug
Any other hemorrhage/ bleeding event \>/= CTCAE grade 3 within four weeks prior to the first dose of the study drug
Thrombotic or embolic venous or arterial events such as cerebrovascular accident
Pregnant or breast-feeding women.
Any condition which could affect the absorption or pharmacokinetics of the study drug
Prior treatment with other Vascular Endothelial Growth Factor (VEGF) (R) inhibitors, including compounds that impact vascularity (i.e. sunitinib, thalidomide, vandetanib, vascular disrupting agents \[VDA\], VEGF-trap and other experimental agents of this class). Only bevacizumab (Avastin) is permitted.

Intervenciones

drug

Sorafenib (Nexavar, BAY43-9006)

Sorafenib 400 mg twice daily (BID)

drug

Placebo

Placebo - 2 tablets twice daily (BID)

Ubicaciones

Ramos Mejía, Buenos Aires, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Córdoba, Córdoba Province, Argentina

Rosario, Santa Fe Province, Argentina

Santa Fé, Argentina

Patrocinadores

PrincipalBayer