Status:
COMPLETED
A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
Lead Sponsor:
Pfizer
Conditions:
Well-differentiated Pancreatic Neuroendocrine Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with unresectable pancreatic neuroendocrine tumors.
Detailed Description
This study is being conducted to meet regulatory post-marketing commitments.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 6 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2018
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01525550
Start Date
June 6 2012
End Date
July 26 2018
Last Update
July 30 2019
Active Locations (26)
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1
Univeristy of California
Orange, California, United States, 92868
2
Columbia University Medical Center
New York, New York, United States, 10032
3
Barwon Health - University Hospital Geelong
Geelong, Victoria, Australia, 3220
4
Cliniques Universitaires Saint-Luc, Gastroenterologie
Brussels, Brussels Gewest, Belgium, 1200