Treatment With SU11248 in Patients With Neuroendocrine Tumors

Phase 2

Completed

• Conditions: Neuroendocrine Tumors
• Interventions: Drug: Sunitinib

• Registration Number: NCT00056693
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-03-20
• Study First Submitted QC: 2003-03-21
• Study First Posted: 2003-03-24
• Study Start: 2003-04
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-18
• Last Update Posted: 2008-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Sunitinib	-

Primary Outcome Measures

Name	Time	Method
Radiographic objective disease response	From screening until disease progression or discontinuation of study

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Philadelphia, Pennsylvania, United States