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

Pfizer

Status and phase: Completed; Phase 4

Conditions: Well-differentiated Pancreatic Neuroendocrine Tumor

Treatments: Drug: sunitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01525550

A6181202

2011-004363-74 (EudraCT Number)

Details and patient eligibility

About

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

Full description

This study is being conducted to meet regulatory post-marketing commitments.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

106 participants in 1 patient group

sunitinib

Experimental group

Treatment:

Drug: sunitinib