Phase I Trial of Combination of FOLFIRI and SOM 230

Gastrointestinal Tumor Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Gastrointestinal Tumor

• NCT number: NCT01434069
• Study type: Interventional
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Status: Completed
• Phase: Phase 1
• Start date: September 2011
• Completion date: December 2015