A Phase III, Multi-center, Placebo-Controlled Trial of Sorafenib (BAY43-9006) in Patients With Relapsed or Refractory Advanced Predominantly Non Squamous Non-Small Cell Lung Cancer (NSCLC) After 2 or 3 Previous Treatment Regimens for Advanced Disease

CompletadoFase 3ClinicalTrials.gov

ID: NCT00863746Tipo: INTERVENTIONALInicio: 1 de abr de 2009Fin estimado: 1 de abr de 2013

Traducción no disponible, mostrando original

Resumen

The purpose of the study is to see if sorafenib plus best supportive care (i.e. in addition to the non-cancer treatments patients would normally receive) is an effective treatment for lung cancer compared to best supportive care alone. The safety and tolerability of the two treatment groups will also be compared. The goal of the study is to test the ability of sorafenib to improve survival compared to best supportive care alone.

Descripción detallada

Acronyms used in Adverse Events section: Disseminated intravascular coagulation (DIC), International normalized ratio (INR), Atrioventricular (AV), Gastrointestinal (GI), Not otherwise specified (NOS), Common Terminology Criteria for Adverse Events (CTCAE), Absolute neutrophil count (ANC), Central nervous system (CNS), Acute respiratory distress syndrome (ARDS), Alanine aminotransferase (ALT), Aspartate aminotransferase (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

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