Try our beta test site

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: January 13, 2012
Last updated: January 14, 2017
Last verified: January 2017
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: 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: June 2012
Estimated Study Completion Date: June 2018
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   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Hide Study Locations
United States, California
Univeristy of California
Orange, California, United States, 92868
United States, Michigan
Research Location and IP Shipment Address: Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Australia, Victoria
Barwon Health - University Hospital Geelong
Geelong, Victoria, Australia, 3220
Cliniques Universitaires Saint-Luc, Gastroenterologie
Bruxelles, Belgium, 1200
China, Beijing
China-Japan Friendship Hospital
Beijing, Beijing, China, 100029
307 Hospital of PLA
Beijing, Beijing, China, 100071
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
China, Jiangsu
Nanjing Bayi Hospital
Nanjing, Jiangsu, China, 210002
China, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Zhongshan Hospital Fudan University
Shanghai, China, 200032
Czech Republic
Masarykuv onkologicky ustav
Brno, Czech Republic, 65653
Fakultni poliklinika
Praha 2, Czech Republic, 128 08
Vseobecna Fakultni Nemocnice v Praze
Praha 2, Czech Republic, 128 08
Hôpital Beaujon
Clichy Cedex, France, 92118
Semmelweis Egyetem/II. Sz. Belgyogyaszati Klinika
Budapest, Hungary, 1088
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
IEO Istituto Europeo di Oncologia, IRCCS
Milano, Italy, 20141
Kyushu University Hospital
Fukuoka-shi, Fukuoka, Japan, 812-8582
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, Norway, 0372
Centrul de Oncologie Sf. Nectarie
Craiova, Dolj, Romania, 200347
Institutul Clinic Fundeni, Centrul de Gastroenterologie si Hepatologie
Bucuresti, Romania, 022328
Narodny Onkologicky ustav
Bratislava, Slovakia, 833 10
South Africa
Wits Clinical Research
Johannesburg, Gauteng, South Africa, South Africa, 2193
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncológico Clara Campal (CIOCC)
Madrid, Spain, 28050
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01525550     History of Changes
Other Study ID Numbers: A6181202
2011-004363-74 ( EudraCT Number )
Study First Received: January 13, 2012
Last Updated: January 14, 2017

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

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors processed this record on March 29, 2017