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

Pfizer1 site in 1 country107 target enrollmentApril 2003

InterventionsSunitinib

Overview

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

Registry

clinicaltrials.gov

Start Date

April 2003

End Date

September 2006

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

•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

•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.

Intervention: Sunitinib

Radiographic objective disease response

Time Frame: From screening until disease progression or discontinuation of study

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)