SOM 230 and Gemcitabine in Advanced Pancreatic Cancer

September 25, 2020 updated by: H. Lee Moffitt Cancer Center and Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 14 days of the administration of the first study treatment. Women must not be lactating. Both men and WOCBP must be advised of the importance of using effective birth control measures during the course of the study.
  • Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information.
  • Screening electrocardiogram (ECG) with a time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole [QT] corrected for heart rate (QTc) < 450 msec

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)
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: Any active (acute or chronic) or uncontrolled infection/ disorders; Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy
  • Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control. (WOCBP must have a negative serum pregnancy test within 14 days prior to administration of pasireotide). Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study.
  • Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR formulations
  • History of noncompliance to medical regimens
  • Patients unwilling to or unable to comply with the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • Pasireotide
Drug: Gemcitabine
Fixed dose: 1000mg/m^2 weekly x3 then 1 week off
Other Names:
  • Gemzar®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Serious Adverse Events
Time Frame: The end of each participant's 28 day cycle
Safety / Tolerability (type, frequency, severity, and relationship of adverse events to study drug)
The end of each participant's 28 day cycle

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Progression Free Survival (PFS)
Time Frame: 3 months
Frequency counts and percentage will be used to summarize the progression-free survival (PFS) in 3 months period.
3 months
Number of Participants With Tumor Response
Time Frame: 6 months
Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST). Objective tumor response will be summarized using frequency counts and percentage.
6 months
Number of Participants With Overall Survival (OS)
Time Frame: 6 months
Frequency counts and percentage will be used to summarize the overall survival (OS) in 6 months period.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

June 29, 2011

First Submitted That Met QC Criteria

June 29, 2011

First Posted (Estimate)

June 30, 2011

Study Record Updates

Last Update Posted (Actual)

September 28, 2020

Last Update Submitted That Met QC Criteria

September 25, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-16456
  • CSOM230CUS16T (Other Identifier: Norvartis)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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