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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Pfizer
Information provided by (Responsible Party):
Pfizer Identifier:
First received: January 13, 2012
Last updated: February 3, 2015
Last verified: February 2015

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

Condition Intervention Phase
Well-differentiated Pancreatic Neuroendocrine Tumor
Drug: sunitinib
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time-to-tumor progression (TTP) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Baseline until death (up to 2 years) ] [ Designated as safety issue: No ]
  • Objective response (OR) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Duration of response (DR) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Time-to-tumor response (TTR) [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Evaluation of the use of Choi criteria [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Evaluation of Chromogranin A response and soluble KIT concentrations [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Pharmacokinetic trough plasma concentrations of sunitinib and its active metabolite (SU12662) [ Time Frame: 4 timepoints up to 5 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2012
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sunitinib Drug: sunitinib
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.

Detailed Description:

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01525550

Contact: Pfizer Call Center 1-800-718-1021

  Hide Study Locations
United States, California
Univeristy of California Terminated
Orange, California, United States, 92868
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Medical Center-Josephine Recruiting
Brownstown, Michigan, United States, 48183
Henry Ford Medical Center-Fairlane Recruiting
Dearborn, Michigan, United States, 48126
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Henry Ford Medical Center Recruiting
Novi, Michigan, United States, 48377
Henry Ford Medical Center Recruiting
West Bloomfield, Michigan, United States, 48322
Henry Ford Medical Center Recruiting
Woodhaven, Michigan, United States, 48183
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Columbia University Medical Center, Recruiting
New York, New York, United States, 10032
United States, Pennsylvania
Guthrie Clinic, Ltd. Recruiting
Sayre, Pennsylvania, United States, 18840
Robert Packer Hospital Recruiting
Sayre, Pennsylvania, United States, 18840
Australia, Victoria
Barwon Health - The Geelong Hospital Recruiting
Geelong, Victoria, Australia, 03220
Cliniques Universitaires Saint-Luc, Gastroenterologie Recruiting
Bruxelles, Belgium, 1200
China, Beijing
307 Hospital of PLA Recruiting
Beijing, Beijing, China, 100071
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
China, Jiangsu
The PLA Bayi hospital of Nanjing Recruiting
Nan Jing, Jiangsu, China, 210002
China, Sichuan
West China Hospital of Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Fudan University Cancer Hospital Recruiting
Shanghai, China, 200032
Zhongshan Hospital Fudan University Recruiting
Shanghai, China, 200032
Czech Republic
Masarykuv onkologicky ustav Recruiting
Brno, Czech Republic, 65653
Fakultni poliklinika Recruiting
Praha 2, Czech Republic, 128 08
Vseobecna Fakultni Nemocnice v Praze Recruiting
Praha 2, Czech Republic, 128 08
North Estonia Medical Centre Foundation Recruiting
Tallinn, Estonia, 13419
Hopital Saint Andre Recruiting
Bordeaux cedex, France, 33075
Hôpital Beaujon Recruiting
Clichy, France, Cedex, 92118
Semmelweis Egyetem/II. Sz. Belgyogyaszati Klinika Recruiting
Budapest, Hungary, 1088
Tata Memorial Hospital Recruiting
Mumbai, Maharashtra, India, 400012
Istituto Europeo di Oncologia Recruiting
Milano, Italy, 20141
A.O.R.N. "A. Cardarelli" Recruiting
Napoli, Italy, 80131
Kyusyu University Hospital Recruiting
Fukuoka-shi, Fukuoka, Japan, 812-8582
National Cancer Center Hospital Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Oslo Universitetssykehus HF Rikshospitalet Recruiting
Oslo, Norway, 0372
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE Recruiting
Lisboa, Portugal, 1099-023
SC Oncolab S.R.L. Recruiting
Craiova, Dolj, Romania, 200385
Institutul Clinic Fundeni, Centrul de Gastroenterologie si Hepatologie Recruiting
Bucuresti, Sector 2, Romania, 022328
Narodny Onkologicky ustav Recruiting
Bratislava, Slovakia, 833 10
South Africa
University of Witwatersrand Oncology Recruiting
Parktown, South Africa, 2193
Centro Oncologico MD Anderson Internacional España Recruiting
Madrid, Spain, 28033
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncológico Clara Campal (CIOCC) Recruiting
Madrid, Spain, 28050
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT01525550     History of Changes
Other Study ID Numbers: A6181202, 2011-004363-74
Study First Received: January 13, 2012
Last Updated: February 3, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
neuroendocrine tumors
adenoma islet cells
carcinoma islet cells
pancreatic neoplasms
angiogenesis inhibitors

Additional relevant MeSH terms:
Adenoma, Islet Cell
Carcinoid Tumor
Neuroendocrine Tumors
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Pancreatic Diseases
Pancreatic Neoplasms
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 25, 2015