Treatment With SU11248 in Patients With Neuroendocrine Tumors

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00056693
First received: March 20, 2003
Last updated: July 18, 2008
Last verified: July 2008
  Purpose

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


Condition Intervention Phase
Neuroendocrine Tumors
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of The Efficacy And Safety Of SU011248 In Patients With Advanced Unresectable Neuroendocrine Tumor

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Radiographic objective disease response [ Time Frame: From screening until disease progression or discontinuation of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess safety (adverse events and lab abnormalities) [ Time Frame: From screening until patient death or discontinuation of study ] [ Designated as safety issue: No ]
  • To assess patient-reported outcomes and treatment-related symptoms [ Time Frame: From screening until patient death or discontinuation of study ] [ Designated as safety issue: No ]
  • To assess pharmacokinetics and biomarkers [ Time Frame: From screening until patient death or discontinuation of study ] [ Designated as safety issue: No ]
  • To assess overall survival at 1 year [ Time Frame: From screening until patient death or discontinuation of study ] [ Designated as safety issue: No ]
  • To assess other measures of antitumor efficacy including TTP and survival [ Time Frame: From screening until patient death or discontinuation of study ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: April 2003
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Sutent, SU011248

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056693

Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
United States, California
Pfizer Investigational Site
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
United States, Illinois
Pfizer Investigational Site
Pinckneyville, Illinois, United States, 62274
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
United States, Missouri
Pfizer Investigational Site
St Louis, Missouri, United States, 63110
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00056693     History of Changes
Other Study ID Numbers: RTKC-0511-015
Study First Received: March 20, 2003
Last Updated: July 18, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Neuroendocrine tumor, advanced disease, sunitinib, Phase 2

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014