a study of necitumumab monotherapy and the qt/qtc interval in patient with advanced solid tumors

Conditions: Solid Tumors

Summary: the purpose of this study is to determine whether treatment with necitumumab monotherapy affects the qt/qtc interval among participants with advanced solid tumors refractory to standard treatment or for which no standard treatment is available.


Eligibility criteria:
inclusion criteria: * have documented advanced or metastatic malignant solid tumors (except for colorectal tumors with kras mutation) that have not responded to standard therapy or for which no standard therapy is available * may have measurable or non-measurable disease * have resolution to grade 0 or 1 by the national cancer institute common terminology criteria for adverse events, version 4.0 (nci-ctcae 4.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy * have an eastern cooperative oncology group performance status (ecog ps) score of 0 or 1 * have adequate hepatic, renal and hematologic function * have potassium, magnesium, and calcium within normal limits * subjects, if female, are surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method during and for 6 months after the treatment period. if male, participants are surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period * female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization 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 \ 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

Keywords: advanced solid tumors