NCT01385956

SOM 230 and Gemcitabine in Advanced Pancreatic Cancer

Phase I Study of Combination of SOM 230 Long Acting Release (LAR) + Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to learn if the study drug SOM 230 in addition to standard therapy of gemcitabine can shrink or slow the growth of pancreatic cancer. The safety and tolerability of different doses of SOM 230 will also be studied. The participants' physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us (the study doctor and Moffitt Cancer Center) decide if SOM 230 is safe and effective.

Detailed description

This is a single-arm, open-label, phase I study of combination therapy with SOM 230 LAR and standard treatment with gemcitabine. We will utilize a staggered, sequential dose-escalation design to define the maximum tolerated dose (MTD) of SOM 230 LAR when combined with standard doses of gemcitabine. Cycle will be defined as 28 days. Treatment will be administered on an outpatient basis. Gemcitabine is administered by IV infusion. The dose should be based on the patient's actual baseline body weight; the dose will be recalculated if there is a weight change of \> 10% from baseline. The dose of gemcitabine will be given over 30 minutes, weekly every 3 weeks followed by 1 week rest period. SOM 230 LAR will be administered as an intramuscular dose determined by the dosing schema, every month.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	SOM 230 LAR	We will attempt dose escalation starting at a lower level 1 of 40 mg since we are using SOM 230 LAR in combination with gemcitabine for the first time.
DRUG	Gemcitabine	Fixed dose: 1000mg/m\^2 weekly x3 then 1 week off

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-05-01
• Completion: 2014-11-01
• First posted: 2011-06-30
• Last updated: 2020-09-28

Locations

1 site across 1 country: United States