None listed
Conditions
Interventions
Intervention1: Sorafenib: 400 mg twice daily (BID)
Control Intervention1: Placebo: 2 tablets twice daily
Sponsors
Bayer HealthCare AG
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: * 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 * 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: o Haemoglobin > 9.0 g/dl o Absolute neutrophil count (ANC) >1,500/mm3 o Platelet count >/= 100,000/µl o Total bilirubin </=1.5 x the upper limit of normal o ALT < 2.5 x upper limit of normal (</= 5 x upper limit of normal in patients with liver metastases) o AST < 2.5 x upper limit of normal (</= 5 x upper limit of normal in patients with liver metastases) o Alkaline phosphatase < 4 x upper limit of normal (</= 5 x upper limit of normal in patients with liver metastases) o PT-INR or PTT < 1.5 x upper limit of normal o Serum creatinine < 1.5 x upper limit of normal o Calculated creatinine clearance of >/= 50 mL/min
Exclusion criteria
Exclusion criteria: Exclusion Criteria: * 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 vers. 3.0) * Uncontrolled hypertension despite two anti-hypertensive medications * History of 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 of the first dose of the study drug * Any other hemorrhage/ bleeding event >/= CTCAE grade 3 within four weeks of 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable is overall survival (OS)Timepoint: initial assessment will be performed at baseline and every 3 weeks thereafter | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate Timepoint: every 3 weeks;Overall Response Rate Timepoint: every 3 weeks;Patient Reported OutcomesTimepoint: Every 3 weeks;Progression-free survival Timepoint: every 3 weeks;Time to Progression Timepoint: Every 3 weeks | — |
Countries
India
Contacts
Public ContactDr. Manish Garg
Country Medical Director India
Outcome results
None listed