Status:
COMPLETED
A 3rd/4th Line Placebo-controlled Trial of Sorafenib in Patients With Predominantly Non Squamous Non-Small Cell Lung Cancer (NSCLC).
Lead Sponsor:
Bayer
Conditions:
Carcinoma
Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 comp...
Detailed Description
Acronyms used in Adverse Events section: Disseminated intravascular coagulation (DIC), International normalized ratio (INR), Atrioventricular (AV), Gastrointestinal (GI), Not otherwise specified (NOS)...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
703 Patients enrolled
Trial Details
Trial ID
NCT00863746
Start Date
April 1 2009
End Date
April 1 2013
Last Update
January 19 2015
Active Locations (182)
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1
Fayetteville, Arkansas, United States, 72703
2
Stanford, California, United States, 94305
3
Philadelphia, Pennsylvania, United States, 19107
4
Ramos Mejía, Buenos Aires, Argentina, B1704ESN