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

Inclusion Criteria

• Locally unresectable or metastatic carcinoid or pancreatic neuroendocrine tumors
• Tumors must be considered well or moderately differentiated (or low to intermediate grade). Patients with poorly differentiated neuroendocrine carcinomas or small cell carcinomas are excluded from the study.
• No prior systemic antineoplastic neuroendocrine tumor treatment (including prior somatostatin analogs). However patients who have received a short course of subcutaneous (SQ) octreotide ( 1 week has elapsed from their last octreotide injection.
• Minimum of four weeks since any major surgery
• Measureable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• Life expectancy 12 weeks or more
• Adequate bone marrow function as shown by: absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L, Platelets ≥ 75 x 10^9/L, hemoglobin (Hgb) > 8 g/dL
• Adequate liver function as shown by: serum bilirubin ≤ 2.0 x upper limit of normal (ULN), and serum transaminases activity ≤ 2 x ULN, with the exception of serum transaminases ( 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