A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors

Status: Recruiting
Phase: Phase 4
Diagnosis: Gastrointestinal Malignancies
NCT ID: NCT01525550 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-210


The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with unresectable pancreatic neuroendocrine tumors.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Matthew Kulke, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Gastrointestinal Research Line, 617-632-5960

Eligibility Criteria

Inclusion Criteria: - Histologically or cytologically proven diagnosis of well-differentiated pancreatic neuroendocrine tumor (according to World Health Organization [WHO 2000] classification). - Disease progression within 12 months prior to study enrollment. - Disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent. Exclusion Criteria: - Patients with poorly differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification). - Prior treatment with any tyrosine kinase inhibitors, anti vascular endothelial growth factor (VEGF) angiogenesis inhibitors, non VEGF targeted angiogenesis inhibitors, or mammalian target of rapamycin (mTOR) inhibitors.
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