Spots Global Cancer Trial Database for Phase I Trial of Combination of FOLFIRI and SOM 230

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Trial Identification

Brief Title: Phase I Trial of Combination of FOLFIRI and SOM 230

Official Title: Phase I Trial of Combination of FOLFIRI and SOM 230 in Advanced Gastrointestinal Malignancies

Study ID: NCT01434069

Conditions

Gastrointestinal Tumor

Interventions

SOM230C LAR

FOLFIRI Infusion

Study Description

Brief Summary: This is a single-arm, open-label, phase I study of combination therapy with SOM 230 and FOLFIRI. We will utilize a sequential dose-escalation design to define the maximum tolerated dose (MTD) of SOM 230 when combined with standard doses of FOLFIRI.

Detailed Description: The goal of this clinical research study is to learn if the study drug SOM 230, also known as Pasireotide long-acting release (LAR), in addition to standard therapy of FOLFIRI (5FU, leucovorin, and irrinotecan) can shrink or slow the growth of gastrointestinal malignancies. The safety of this drug in combination with standard chemotherapy (FOLFIRI) will also be studied. The participant's physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us decide if Pasireotide LAR is safe and effective.