Treatment With SU11248 in Patients With Neuroendocrine Tumors - Tabular View

Tracking Information

First Received Date ^ICMJE

March 20, 2003

Last Updated Date

July 18, 2008

Start Date ^ICMJE

April 2003

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

To assess the safety and efficacy of SU11248 in patients with neuroendocrine tumors.

Change History

Complete list of historical versions of study NCT00056693 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

To assess other measures of antitumor efficacy including TTP and survival To assess patient-reported outcomes and treatment-related symptoms To assess safety (adverse events and lab abnormalities)

Descriptive Information

Brief Title ^ICMJE

Treatment With SU11248 in Patients With Neuroendocrine Tumors

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Neuroendocrine Tumors

Intervention ^ICMJE

Drug: Sunitinib

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

107

Completion Date

September 2006

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00056693

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer Inc

Study ID Numbers ^ICMJE

RTKC-0511-015

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP