The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors
Conditions
Pancreatic Neuroendocrine Tumors
Conditions: official terms
Adenoma, Islet Cell - Apudoma - Carcinoid Tumor - Neuroendocrine Tumors
Study Type
Observational
Study Phase
N/A
Study Design
Time Perspective: Prospective
Intervention
Name: sunitinib
Type: Drug
Overall Status
Recruiting
Summary
This study is a multi-center, prospective, non-interventional (NI) study evaluating the safety and efficacy of sunitinib in Chinese patients with progressive, unresectable, advanced or metastatic well-differentiated, pancreatic neuroendocrine tumors(pNET). 100 adults with progressive advanced or metastatic well-differentiated unresectable pNET will be recruited in China hospitals. Each subject will be followed up overall survival (OS) time or the date of withdrawal and subjects who remain alive after study completion will have their OS time censored on the last date known to be alive. Eligible subjects will be enrolled to receive at least one dose of sunitinib orally at 37.5 mg once a day on a continuous daily dosing regimen (CDD) or dosage modification is based on daily clinic practice. Subjects will be treated until disease progress, unacceptable toxicity, withdrawal from the study at their own request, or until the final analysis for the study is performed. The NI study will capture observations that will be used for evaluating the safety profile of sunitinib, including: subject demographics, medical history and medications. Safety assessments, treatment data and any other laboratory examination results, which were done according to routine clinical practice, will be collected at all visits.
Detailed Description
The sunitinib non-interventional (NI) study is a real world observational study which represents the usual and customary treatment of patients and being proposed to collect data systematically and to assess the safety and efficacy in Chinese patients with progressive, unresectable, advanced or metastatic well-differentiated, pancreatic neuroendocrine tumors.It is designed and conducted to meet CFDA post-marketing commitments. non-probability sample
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

- Subjects who are willing to follow up visits within current clinical practice.

- Histologically or cytologically proven diagnosis of well-differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification)

- Unresectable (as assessed by the investigator) or metastatic disease documented on a scan

- A minimum age of 18 years

Exclusion Criteria:

- Patients with poorly-differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification)

- Patients who have received at least one dosage of sunitinib treatment prior to signing informed consent form will be excluded from participating in this study.
Locations
Oncology Department, The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Status: Not yet recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Science
Beijing, Beijing, China
Status: Not yet recruiting
Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China
Status: Not yet recruiting
The Affiliated Tumour Hospital of Harbin Medical University
Haerbin, Heilongjiang, China
Status: Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Status: Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Status: Recruiting
Nanjing Bayi Hospital/The Department of Medical Oncology PLA Cancer Center of Bayi Hospital
Nanjing, Jiangsu, China
Status: Not yet recruiting
Nanjing General Hospital of Nanjing Military Command/Hepatobiliary Surgery Department
Nanjing, Jiangsu, China
Status: Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Status: Not yet recruiting
The PLA 307 Hospital
Beijing, China
Status: Recruiting
Digestive surgery Department, The First Affiliated Hospital, The Fourth Military Medical University
Xi'an, China
Status: Recruiting
Start Date
December 2014
Completion Date
November 2022
Sponsors
Pfizer
Source
Pfizer
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page