This trial is active, not recruiting.

Condition well-differentiated pancreatic neuroendocrine tumor
Treatment sunitinib
Phase phase 4
Targets VEGF, PDGF, FLT-3, KIT
Sponsor Pfizer
Start date June 2012
End date March 2016
Trial size 80 participants
Trial identifier NCT01525550, 2011-004363-74, A6181202


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Masking open label
Sunitinib capsules will be given orally at continuous daily dosing with a starting dose of 37.5 mg. One cycle is equal to 28 days.

Primary Outcomes

Progression-Free Survival (PFS)
time frame: Baseline up to 2 years

Secondary Outcomes

Time-to-tumor progression (TTP)
time frame: Baseline up to 2 years
Overall survival (OS)
time frame: Baseline until death (up to 2 years)
Objective response (OR)
time frame: Baseline up to 2 years
Duration of response (DR)
time frame: Baseline up to 2 years
Time-to-tumor response (TTR)
time frame: Baseline up to 2 years
Evaluation of the use of Choi criteria
time frame: Baseline up to 2 years
Evaluation of Chromogranin A response and soluble KIT concentrations
time frame: Baseline up to 2 years
Pharmacokinetic trough plasma concentrations of sunitinib and its active metabolite (SU12662)
time frame: 4 timepoints up to 5 months
Patient reported outcomes is defined as health related quality of life using the self administered European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (EORTC QLQ C30) and EORTC QLQ GI.NET21
time frame: Baseline up to 2 years

Eligibility Criteria

All participants at least 18 years old.

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.

Additional Information

Official title A Single-arm Open-label International Multi-center Study Of The Efficacy And Safety Of Sunitinib Malate (su011248, Sutent (Registered)) In Patients With Progressive Advanced Metastatic Well-differentiated Unresectable Pancreatic Neuroendocrine Tumors
Description This study is being conducted to meet regulatory post-marketing commitments.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Pfizer.