A Single Arm Open-Label International Multi Center Study Of The Efficacy And Safety Of Sunitinib Malate (SU011248, Sutent®) In Patients With Progressive Advanced Metastatic Well Differentiated Unresectable Pancreatic Neuroendocrine Tumors
This study is being conducted to meet regulatory post-marketing commitments.
- Histologically or cytologically proven diagnosis of well-differentiated pancreatic
neuroendocrine tumor (according to World Health Organization [WHO 2000]
- Disease progression within 12 months prior to study enrollment.
- Disease that is not amenable to surgery, radiation, or combined modality therapy with
- 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.
Type of Study:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Progression-Free Survival (PFS)
Outcome Time Frame:
Baseline up to 2 years
Pfizer CT.gov Call Center
United States: Food and Drug Administration
- Well-differentiated Pancreatic Neuroendocrine Tumor
- neuroendocrine tumors
- adenoma islet cells
- carcinoma islet cells
- pancreatic neoplasms
- angiogenesis inhibitors
- Neuroendocrine Tumors
- Adenoma, Islet Cell
|Henry Ford Hospital||Detroit, Michigan 48202|
|Robert Packer Hospital||Sayre, Pennsylvania 18840|
|Henry Ford Medical Center||Dearborn, Michigan 48126|
|Henry Ford Medical Center-Fairlane||Dearborn, Michigan 48126|
|Guthrie Clinic, Ltd.||Sayre, Pennsylvania 18840|
|Univeristy of California||Orange, CA, California Orange, CA|
|Henry Ford Medical Center-Josephine||Brownstown, Michigan 48183|