Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)

December 17, 2020 updated by: Novartis Pharmaceuticals

A Phase I, Multi-center, Open-label, Dose Escalation Study of Pasireotide (SOM230) LAR in Patients With Advanced Neuroendocrine Tumors (NETs)

This study designed to determine the Maximum Tolerated Dose (MTD) for patients with advanced Neuroendocrine Tumors (NETs) and to characterize the safety, tolerability, Pharmacokinetics and preliminary efficacy of pasireotide LAR administered i.m. once every 28 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

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
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center Cedars Sinai 4
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute SC-1
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute SC-6
    • Texas
      • Houston, Texas, United States, 77030-4009
        • University of Texas/MD Anderson Cancer Center UT MD Anderson Cancer Ctr

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:

  • ≥18 yrs old, histologically confirmed advanced well or moderately differentiated neuroendocrine tumor/carcinoma
  • unresectable metastatic NET tumor with measurable disease
  • life expectancy ≥ 12 weeks

Exclusion Criteria:

  • Patients with CNS metastases who are neurologically unstable or requiring increasing doses of steroids to control their CNS disease
  • patients with known hypersensitivity to somatostatin analogs
  • patients with symptomatic cholelithiasis in the past 2 months
  • patients with history of another known primary malignancy with exception of non-melanoma skin cancer or carcinoma in situ of uterine cervix
  • patients with known history of hepatitis C or chronic active hepatitis B
  • patients with diagnosis of HIV.

Other protocol-defined inclusion/exclusion criteria may apply

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: Pasireotide LAR
Drug: Pasireotide LAR
Other Names:
  • SOM230

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the MTD/RP2D of pasireotide LAR when administered i.m. q28 days to patients with advanced NETs
Time Frame: Sequentiona 56 day cohorts until the MTD is determined
Frequency of dose-limiting toxicities (DLTs) at each dose level associated with q28 days administration of pasireotide LAR during the first 2 treatment cycles.
Sequentiona 56 day cohorts until the MTD is determined

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assess the safety and tolerability of pasireotide LAR
Time Frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
Incidence of adverse drug events, overall and by severity and incidence of serious adverse events and laboratory abnormalities. Also, changes in laboratory assessments, electrocardiograms, Holter monitor, imaging for gallstones, and assessment of physical examinations such as vital signs
minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
assess the pharmacokinetics (PK) of pasireotide LAR
Time Frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
Pasireotide Cmax and Ctrough
minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
assess the pharmacodynamics (PD) of pasireotide LAR
Time Frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
Changes from baseline values in IGF-1, chromogranin A and neuron-specific enolase
minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
assess the preliminary efficacy (anti-tumor activity) of pasireotide LAR.
Time Frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles
Disease control rate (CR+PR+SD as assessed by RECIST 1.0). Also measure progression free survival (PFS).
minimum of twelve 28 day cycles to approximately eighteen 28 day cycles

Collaborators and Investigators

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

Sponsor

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

August 1, 2011

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

May 18, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimate)

June 2, 2011

Study Record Updates

Last Update Posted (Actual)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 17, 2020

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSOM230D2101

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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