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

Novartis

Status and phase: Completed; Phase 1

Conditions: Neuroendocrine Tumors

Treatments: Drug: Pasireotide LAR

Study type: Interventional

Funder types: Industry

Identifiers

NCT01364415

CSOM230D2101

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Pasireotide LAR

Experimental group

Treatment:

Drug: Pasireotide LAR