Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)

A Phase I, Multi-center, Open-label, Dose Escalation Study of Pasireotide (SOM230) LAR in Patients With Advanced Neuroendocrine Tumors (NETs)

This study designed to determine the Maximum Tolerated Dose (MTD) for patients with advanced Neuroendocrine Tumors (NETs) and to characterize the safety, tolerability, Pharmacokinetics and preliminary efficacy of pasireotide LAR administered i.m. once every 28 days.

Inclusion Criteria:

• ≥18 yrs old, histologically confirmed advanced well or moderately differentiated neuroendocrine tumor/carcinoma
• unresectable metastatic NET tumor with measurable disease
• life expectancy ≥ 12 weeks

Exclusion Criteria:

• Patients with CNS metastases who are neurologically unstable or requiring increasing doses of steroids to control their CNS disease
• patients with known hypersensitivity to somatostatin analogs
• patients with symptomatic cholelithiasis in the past 2 months
• patients with history of another known primary malignancy with exception of non-melanoma skin cancer or carcinoma in situ of uterine cervix
• patients with known history of hepatitis C or chronic active hepatitis B
• patients with diagnosis of HIV.

Other protocol-defined inclusion/exclusion criteria may apply