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

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country20 target enrollmentJune 2011

ConditionsPancreatic Cancer

InterventionsSOM 230 LAR Gemcitabine

DrugsSOM 230 LAR Gemcitabine

Overview

Phase: Phase 1
Intervention: SOM 230 LAR
Conditions: Pancreatic Cancer
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Enrollment: 20
Locations: 1
Primary Endpoint: Number of Participants With Serious Adverse Events
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

November 2014

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Cytologically or histologically confirmed evidence of epithelial cancer (adenocarcinoma) of the exocrine pancreas
•Metastatic or locally advanced disease. Patients with measurable and with non measurable disease, as per RECIST criteria are eligible.
•Minimum of 4 weeks since any major surgery, completion of radiation
•Prior treatment with gemcitabine alone or 5-fluorouracil (5-FU) with radiation as an adjuvant therapy will be allowed if \> 6 months
•Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
•Life expectancy ≥ 12 weeks
•Adequate bone marrow function as shown by: absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L, Platelets ≥ 100 x 10\^9/L, hemoglobin (Hgb) \> 9 g/dL
•Adequate liver function as shown by: serum bilirubin ≤ 1.5 x upper limit of normal (ULN), and serum transaminases activity ≤ 3 x ULN, with the exception of serum transaminases (\< 5 x ULN) if the patient has liver metastases.
•Adequate renal function as shown by serum creatinine ≤ 1.5 x ULN
•Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.

Exclusion Criteria

•Prior treatment with any cytotoxic chemotherapy except as an adjuvant therapy
•Have undergone major surgery within 4 weeks prior to study enrollment
•Chronic treatment with steroids or any other immunosuppressant drugs
•Should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry.
•Untreated brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.
•Patients with uncontrolled diabetes mellitus or a fasting plasma glucose \> 1.5 ULN or glycosylated hemoglobin (HbA1c) \>8%. Note: At the principle investigator's discretion, non-eligible patients can be re-screened after adequate medical therapy has been instituted
•Patients with symptomatic cholelithiasis
•QT related exclusion criteria: Fridericia Correction Formula (QTcF) at screening \> 450 msec; History of syncope or family history of idiopathic sudden death; Sustained or clinically significant cardiac arrhythmias; Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade atrioventricular (AV) block; Concomitant medication(s) known to prolong the QT interval (patient must be off the drug for 2 weeks to be eligible)
•Patients who have congestive heart failure \[New York Heart Association (NYHA) Class III or IV\], unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the 6 months preceding enrollment
•Known history of human immunodeficiency virus (HIV)

Arms & Interventions

SOM 230 LAR and Gemcitabine

Combination Therapy: Dose escalation of SOM 230 LAR and standard treatment with gemcitabine. 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.

Intervention: SOM 230 LAR