A Study of Necitumumab Monotherapy and the QT/QTc Interval in Patient With Advanced Solid Tumors

Exclusion Criteria

• •Are currently enrolled in, or discontinued a clinical trial involving an anticancer investigational product, or concurrently enrolled in any other type of medical research
• •Had therapeutic radiotherapy within 14 days prior to the first dose of study therapy
• •Have received necitumumab or any other monoclonal antibody (mAb) targeting the EGFR (epidermal growth factor receptor) as the most recent prior treatment
• •Have documented and/or symptomatic brain or leptomeningeal metastases
• •Have a clinically relevant abnormality on the ECG, preventing an accurate measurement of the QT interval
• •Have current clinically-relevant coronary artery disease or uncontrolled congestive heart failure
• •Have medically uncontrolled angina pectoris, or has experienced myocardial infarction within 6 months prior to the first dose of study therapy
• •Have an implantable pacemaker or automatic implantable cardioverter defibrillator
• •Have received sotalol within 10 days prior to the first dose of study therapy
• •Have a history of risk factors for ventricular tachycardia or Torsades de pointes, history of fainting, unexplained loss of consciousness, or convulsions
• •Have a history of heart failure, congestive heart failure, myocardial infarction, cardiomyopathy, hypokalemia, hypoglycemia, or hypomagnesia
• •Have any evidence of conduction abnormality (eg, increased QRS complex)
• •Have congenital long QT syndrome
• •Have a prolonged QTc interval mean on pretreatment ECG
• •Have a heart rate \< 50 bpm or \> 100 bpm at rest
• •Are using a medication that is known to prolong the ECG QT interval, or have received a medication known to prolong the ECG QT interval within 14 days prior to first dose of study therapy
• •Have a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab, or a known history of severe (Grade 3-4) hypersensitivity reaction to any monoclonal antibody
• •Have an ongoing or active infection (requiring treatment), including active tuberculosis or known infection with the human immunodeficiency virus
• •If female, are pregnant or breastfeeding
• •Have a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder