Treatment With SU11248 in Patients With Neuroendocrine Tumors

July 18, 2008 updated by: Pfizer

A Phase II Study Of The Efficacy And Safety Of SU011248 In Patients With Advanced Unresectable Neuroendocrine Tumor

To assess the safety and efficacy of SU11248 in patients with Neuroendocrine Tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 2

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
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35294
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, United States, 90033
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90033-0800
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94115-1705
        • Pfizer Investigational Site
    • Illinois
      • Pinckneyville, Illinois, United States, 62274
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02215
        • Pfizer Investigational Site
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63110
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Pfizer Investigational Site

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:

  • Histologically or cytologically proven diagnosis of carcinoid tumor or pancreatic islet cell tumor.
  • Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).
  • ECOG performance status 0 or 1

Exclusion Criteria:

  • Diagnosis of small-cell carcinoma, pheochromocytoma/paraganglioma, Merkel cell carcinoma, or any other second malignancy within the last 5 years except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri.
  • Prior treatment with any tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors. Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Sunitinib
Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity
Other Names:
  • Sutent, SU011248

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Radiographic objective disease response
Time Frame: From screening until disease progression or discontinuation of study
From screening until disease progression or discontinuation of study

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess safety (adverse events and lab abnormalities)
Time Frame: From screening until patient death or discontinuation of study
From screening until patient death or discontinuation of study
To assess patient-reported outcomes and treatment-related symptoms
Time Frame: From screening until patient death or discontinuation of study
From screening until patient death or discontinuation of study
To assess pharmacokinetics and biomarkers
Time Frame: From screening until patient death or discontinuation of study
From screening until patient death or discontinuation of study
To assess overall survival at 1 year
Time Frame: From screening until patient death or discontinuation of study
From screening until patient death or discontinuation of study
To assess other measures of antitumor efficacy including TTP and survival
Time Frame: From screening until patient death or discontinuation of study
From screening until patient death or discontinuation of study

Collaborators and Investigators

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

Sponsor

Pfizer

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

April 1, 2003

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

March 20, 2003

First Submitted That Met QC Criteria

March 21, 2003

First Posted (Estimate)

March 24, 2003

Study Record Updates

Last Update Posted (Estimate)

July 21, 2008

Last Update Submitted That Met QC Criteria

July 18, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTKC-0511-015

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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