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

Purpose

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

Condition	Intervention	Phase
Neuroendocrine Tumors	Drug: Sunitinib	Phase II

MedlinePlus related topics:

Cancer

Drug Information available for:

Sunitinib Sunitinib malate

U.S. FDA Resources

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

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

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

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

Keywords provided by Pfizer:

Neuroendocrine tumor, advanced disease, sunitinib, Phase 2

Study placed in the following topic categories:

Neuroectodermal Tumors

Sunitinib

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Neuroendocrine Tumors

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Antineoplastic Agents

Growth Substances

Therapeutic Uses

Physiological Effects of Drugs

Neoplasms, Nerve Tissue

Growth Inhibitors

Angiogenesis Modulating Agents

Angiogenesis Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

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