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.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01525550
First received: January 13, 2012
Last updated: May 1, 2015
Last verified: May 2015
  Purpose

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 2016
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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01525550

  Hide Study Locations
Locations
United States, California
Univeristy of California
Orange, California, United States, 92868
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Medical Center-Josephine
Brownstown, Michigan, United States, 48183
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, United States, 48126
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Henry Ford Medical Center
Novi, Michigan, United States, 48377
Henry Ford Medical Center
West Bloomfield, Michigan, United States, 48322
Henry Ford Medical Center
Woodhaven, Michigan, United States, 48183
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Columbia University Medical Center,
New York, New York, United States, 10032
Australia, Victoria
Barwon Health - The Geelong Hospital
Geelong, Victoria, Australia, 03220
Belgium
Cliniques Universitaires Saint-Luc, Gastroenterologie
Bruxelles, Belgium, 1200
China, Beijing
307 Hospital of PLA
Beijing, Beijing, China, 100071
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
China-Japan Friendship Hospital
Beijing, Beijing, China, 100029
China, Jiangsu
The PLA Bayi hospital of Nanjing
Nan Jing, Jiangsu, China, 210002
China, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
China
Fudan University Cancer Hospital
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
France
Hopital Saint Andre
Bordeaux cedex, France, 33075
Hôpital Beaujon
Clichy, France, Cedex, 92118
Hungary
Semmelweis Egyetem/II. Sz. Belgyogyaszati Klinika
Budapest, Hungary, 1088
India
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Italy
Istituto Europeo di Oncologia
Milano, Italy, 20141
Japan
Kyusyu University Hospital
Fukuoka-shi, Fukuoka, Japan, 812-8582
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Norway
Oslo Universitetssykehus HF Rikshospitalet
Oslo, Norway, 0372
Romania
Centrul de Oncologie Sf. Nectarie
Craiova, Dolj, Romania, 200347
Institutul Clinic Fundeni, Centrul de Gastroenterologie si Hepatologie
Bucuresti, Sector 2, Romania, 022328
Slovakia
Narodny Onkologicky ustav
Bratislava, Slovakia, 833 10
South Africa
University of Witwatersrand Oncology
Parktown, South Africa, 2193
Spain
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncológico Clara Campal (CIOCC)
Madrid, Spain, 28050
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01525550     History of Changes
Other Study ID Numbers: A6181202, 2011-004363-74
Study First Received: January 13, 2012
Last Updated: May 1, 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
sunitinib
neoplasms
carcinoma
adenoma

Additional relevant MeSH terms:
Adenoma, Islet Cell
Apudoma
Carcinoid Tumor
Neuroendocrine Tumors
Adenocarcinoma
Adenoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
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
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2015