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

Novartis Pharmaceuticals29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuroendocrine Tumors

Interventions

Pasireotide LARDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Cedars Sinai Medical Center Cedars Sinai 4

Los Angeles, California, United States

H. Lee Moffitt Cancer Center & Research Institute SC-1

Tampa, Florida, United States

Dana Farber Cancer Institute SC-6

Boston, Massachusetts, United States

University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr

Houston, Texas, United States

Outcomes

Primary Outcomes

Determine the MTD/RP2D of pasireotide LAR when administered i.m. q28 days to patients with advanced NETs

Frequency of dose-limiting toxicities (DLTs) at each dose level associated with q28 days administration of pasireotide LAR during the first 2 treatment cycles.

Time frame: Sequentiona 56 day cohorts until the MTD is determined

Secondary Outcomes

assess the safety and tolerability of pasireotide LAR

Incidence of adverse drug events, overall and by severity and incidence of serious adverse events and laboratory abnormalities. Also, changes in laboratory assessments, electrocardiograms, Holter monitor, imaging for gallstones, and assessment of physical examinations such as vital signs

Time frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles

assess the pharmacokinetics (PK) of pasireotide LAR

Pasireotide Cmax and Ctrough

Time frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles

assess the pharmacodynamics (PD) of pasireotide LAR

Changes from baseline values in IGF-1, chromogranin A and neuron-specific enolase

Time frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles

assess the preliminary efficacy (anti-tumor activity) of pasireotide LAR.

Disease control rate (CR+PR+SD as assessed by RECIST 1.0). Also measure progression free survival (PFS).

Time frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles

Data from ClinicalTrials.gov

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