Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)

Exclusion Criteria

• •Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
• •Patients with prior or concurrent malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for 5 years
• •Patients with uncontrolled diabetes mellitus or a fasting plasma glucose \> 1.5 ULN or glycosylated hemoglobin (HbA1c) \>8%. Note: At the principle investigator's discretion, non-eligible patients can be re-screened after adequate medical therapy has been instituted.
• •Patients with symptomatic cholelithiasis
• •Patients who have congestive heart failure: New York Heart Association (NYHA) Class III or IV, unstable angina, or a history of acute myocardial infarction within the 6 months preceding enrollment
• •Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
• •* Severely impaired lung function
• •* Any active (acute or chronic) or uncontrolled infection/ disorders
• •* Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy
• •Known hypersensitivity to somatostatin analogues or any component of the pasireotide LAR formulation
• •Corrected QT interval (QTcF) of \>470 msec on screening Electrocardiogram (ECG)
• •Risk factors for Torsades de Pointes such as cardiac failure, clinically significant/symptomatic bradycardia
• •Clinically significant hypokalemia or hypomagnesemia that are not correctable
• •History of sustained ventricular tachycardia, ventricular fibrillation, advanced heart block, or idiopathic syncope thought to be related to ventricular arrhythmia
• •Concomitant medication(s) known to increase the QT interval
• •History of noncompliance to medical regimens or unwillingness to comply with the protocol