A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC

Exclusion Criteria

• •Subject has a known hypersensitivity to granisetron or any 5-HT3 receptor antagonist.
• •Subject has a history or presence of clinically significant abnormal 12-lead ECG or an ECG with QTc by Bazett's correction of \> 450 msec in men and \> 470 msec in women on the screening ECG.
• •Subject has PR \> 240 msec, QRS \> 110 msec, or a history of prolongation of QT interval.
• •Subject has a family history of long QT syndrome.
• •Subject has a history of cardiac disease, including congenital long QT syndrome, angina, myocardial ischemia or infarction, congestive heart failure, myocarditis, or chest pain or dyspnea on exertion.
• •Subject has an electrolyte disturbance, such as uncorrected hypokalemia/hyperkalemia, hypomagnesemia, or hypocalcemia.
• •Subject has idiopathic cardiomyopathy, syncope, epilepsy, hypertrophic cardiomyopathy, or other clinically significant cardiac disease.
• •Subject is pregnant or breast-feeding.
• •Subject is planning to receive multiple-day chemotherapy.
• •Subject has taken any of the following agents within 7 days prior to initiation of chemotherapy (the study): 5-HT3 receptor antagonists, phenothiazines, benzamides, domperidone, cannabinoids, or NK-1 receptor antagonist.
• •Subject has taken any benzodiazepine within 1 day (24 hours) prior to initiation of chemotherapy (the study).
• •Subject is scheduled to receive any other chemotherapeutic agent from Day 2 through Day 6.
• •Subject is scheduled to receive any radiation therapy to the abdomen or pelvis from Day -5 through Day 6.
• •Subject has received systemic corticosteroids or sedative antihistamines within 72 hours of Day 1 of the study, except as premedication for chemotherapy (e.g., taxanes, pemetrexed).
• •Subject has symptomatic primary or metastatic central nervous system (CNS) disease.
• •Subject has ongoing vomiting, retching, or nausea caused by any etiology, or has a history of anticipatory nausea and vomiting.
• •Subject has vomited and/or has had dry heaves or retching within 24 hours prior to the start of HEC on Day 1.
• •Subject is NOT able to swallow oral medications (pills) without difficulty.