Spots Global Cancer Trial Database for The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors
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Trial Identification
Brief Title: The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors
Official Title: A Multi Center, Prospective, Non Interventional (NI) Study of the Safety and Efficacy of Sunitinib in Chinese Patients With Progressive Advanced or Metastatic Well Differentiated Unresectable Pancreatic Neuroendocrine Tumors
Study ID: NCT02282059
Conditions
Interventions
Study Description
Brief 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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Oncology Department, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
SUN Yat-Sen University Cancer Center, Guangzhou, Guangdong, China
The Affiliated Tumour Hospital of Harbin Medical University, Haerbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Eastern Theater General Hospital ,QinHuai District Medical Area, Nanjing, Jiangsu, China
General Hospital of Eastern Theater Command, Nanjing, Jiangsu, China
Nanjing Bayi Hospital, Nanjing, Jiangsu, China
Nanjing General Hospital of Nanjing Military Command/Hepatobiliary Surgery Department, Nanjing, Jiangsu, China
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
Digestive surgery Department, The First Affiliated Hospital, The Fourth Military Medical University, Xi'an, Shannxi, China
The First Affiliated Hospital，Air Force Medical University, Xi'an, Shannxi, China
Air Force Medical University, Xi'an, Shanxi, China
West China Hospital of Sichuan University/Hepatobiliary Pancreatic Surgery, Chengdu, Sichuan, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Tianjin Cancer Hospital, Tianjin, Tianjin, China
Zhejiang Cancer Hospital, Oncology department, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Fifth Medical Center of PLA General Hospital, Beijing, , China
The PLA of 307 Hospital, Beijing, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Tianjin Medical University General Hospital/General Surgery, Tianjin, , China
Tianjin Medical University General Hospital, Tianjin, , China
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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