Treatment With SU11248 in Patients With Neuroendocrine Tumors - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00056693

Purpose

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

Condition	Intervention	Phase
Neuroendocrine Tumors	Drug: Sunitinib	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer

Drug Information available for: Sunitinib malate Sunitinib

U.S. FDA Resources

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
A: Experimental	Drug: Sunitinib Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity

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

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
San Francisco, California, United States, 94115-1705
Pfizer Investigational Site
Los Angeles, California, United States, 90033
Pfizer Investigational Site
Los Angeles, California, United States, 90033-0800
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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Pfizer:

Neuroendocrine tumor, advanced disease, sunitinib, Phase 2

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Angiogenesis Inhibitors
Pharmacologic Actions
Neuroendocrine Tumors

Neuroectodermal Tumors
Neoplasms
Sunitinib
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on November 27, 2009