A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
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
2 other identifiers
interventional
106
15 countries
26
Brief Summary
The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with unresectable pancreatic neuroendocrine tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2012
Longer than P75 for phase_4
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2012
CompletedFirst Posted
Study publicly available on registry
February 3, 2012
CompletedStudy Start
First participant enrolled
June 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2016
CompletedResults Posted
Study results publicly available
May 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2018
CompletedJuly 30, 2019
July 1, 2019
3.8 years
January 13, 2012
March 8, 2017
July 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS): Investigator Assessment
Investigator assessed PFS was defined as the time (in months) from the date of enrollment in study to the date of first documented objective tumor progression or death (due to any cause), whichever occurs first. PFS calculated as (first event date minus date of enrollment plus 1)/30.4. If progression or death was not observed, the participant was censored at the date of the participant's last progression-free tumor assessment prior to the study cut-off date. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria was defined as: greater than or equal to (\>=) 20 percent increase in sum of longest diameter (LD) of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. The analysis was performed by Kaplan-Meier method.
Baseline until disease progression or death due to any cause (up to 1226 days)
Secondary Outcomes (27)
Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment
Baseline until disease progression or death due to any cause (up to 1226 days)
Time to Tumor Progression (TTP): Investigator Assessment
Baseline until first documented tumor progression (up to 1226 days)
Overall Survival (OS)
Baseline until death or end of study (up to 1939 days)
Percentage of Participants With Objective Response (OR): Investigator Assessment
Baseline until disease progression or death due to any cause (up to 1226 days)
Duration of Response (DOR): Investigator Assessment
Baseline until disease progression or death due to any cause (up to 1226 days)
- +22 more secondary outcomes
Study Arms (1)
sunitinib
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (26)
Univeristy of California
Orange, California, 92868, United States
Columbia University Medical Center
New York, New York, 10032, United States
Barwon Health - University Hospital Geelong
Geelong, Victoria, 3220, Australia
Cliniques Universitaires Saint-Luc, Gastroenterologie
Brussels, Brussels Gewest, 1200, Belgium
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
307 Hospital of PLA
Beijing, Beijing Municipality, 100071, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Nanjing Bayi Hospital
Nanjing, Jiangsu, 210002, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Zhongshan Hospital Fudan University
Shanghai, 200032, China
Masarykuv onkologicky ustav
Brno, 656 53, Czechia
Fakultni poliklinika
Prague, 128 08, Czechia
Vseobecna Fakultni Nemocnice v Praze
Prague, 128 08, Czechia
Hôpital Beaujon
Clichy, 92118, France
Semmelweis Egyetem/II. Sz. Belgyogyaszati Klinika
Budapest, 1088, Hungary
Tata Memorial Hospital
Mumbai, Maharashtra, 400012, India
IEO Istituto Europeo di Oncologia, IRCCS
Milan, 20141, Italy
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, 0372, Norway
Centrul de Oncologie Sf. Nectarie
Craiova, Dolj, 200347, Romania
Institutul Clinic Fundeni, Centrul de Gastroenterologie si Hepatologie
Bucharest, 022328, Romania
Narodny Onkologicky ustav
Bratislava, 833 10, Slovakia
Wits Clinical Research
Johannesburg, Gauteng, 2193, South Africa
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncológico Clara Campal (CIOCC)
Madrid, 28050, Spain
Related Publications (1)
Fazio N, Kulke M, Rosbrook B, Fernandez K, Raymond E. Updated Efficacy and Safety Outcomes for Patients with Well-Differentiated Pancreatic Neuroendocrine Tumors Treated with Sunitinib. Target Oncol. 2021 Jan;16(1):27-35. doi: 10.1007/s11523-020-00784-0. Epub 2021 Jan 7.
PMID: 33411058DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Masking
- NONE
- Purpose
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2012
First Posted
February 3, 2012
Study Start
June 6, 2012
Primary Completion
March 19, 2016
Study Completion
July 26, 2018
Last Updated
July 30, 2019
Results First Posted
May 19, 2017
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.