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The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors

NCT02282059

CompletedN/A

Sponsor: Pfizer

Conditions: Pancreatic Neuroendocrine Tumors

Interventions: sunitinib

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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 (24)

Hefei, An'hui, China
Beijing, Beijing Municipality, China
Guangzhou, Guangdong, China
Haerbin, Heilongjiang, China
Zhengzhou, Henan, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Xi'an, Shannxi, China
Xi'an, Shannxi, China
Xi’an, Shanxi, China
Chengdu, Sichuan, China
Chengdu, Sichuan, China
Tianjin, Tianjin Municipality, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Beijing, China
Beijing, China
Shanghai, China
Tianjin, China
Tianjin, China