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

Pancreatic Neuroendocrine Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282059
• Other study ID #: A6181215
• Status: Completed
• Start date: December 12, 2014
• Est. completion date: December 12, 2022

Study information

• Verified date: March 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 12, 2022
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• Pancreatic Neuroendocrine Tumors

Intervention

Drug:
• sunitinib
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

Locations

Country	Name	City	State
China	Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Fifth Medical Center of PLA General Hospital	Beijing
China	The PLA of 307 Hospital	Beijing
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	West China Hospital of Sichuan University/Hepatobiliary Pancreatic Surgery	Chengdu	Sichuan
China	SUN Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	The Affiliated Tumour Hospital of Harbin Medical University	Haerbin	Heilongjiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital, Oncology department	Hangzhou	Zhejiang
China	Oncology Department, The Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Eastern Theater General Hospital ,QinHuai District Medical Area	Nanjing	Jiangsu
China	General Hospital of Eastern Theater Command	Nanjing	Jiangsu
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Nanjing Bayi Hospital	Nanjing	Jiangsu
China	Nanjing General Hospital of Nanjing Military Command/Hepatobiliary Surgery Department	Nanjing	Jiangsu
China	Fudan University Shanghai Cancer Center	Shanghai
China	Tianjin Cancer Hospital	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin
China	Tianjin Medical University General Hospital/General Surgery	Tianjin
China	Air Force Medical University	Xi'an	Shanxi
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	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to	Every 2 to 4 weeks up to 8 years
Secondary	Progression-Free Survival (PFS)	the time from enrollment to first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS data will be censored on the date of the last tumor assessment on study for subjects who do not have objective tumor progression and who do not die while on study. Subjects lacking an evaluation of tumor response after enrollment will have their PFS time censored on the date of enrollment.	Every 1 to 6 months up to 8 years
Secondary	Overall Survival (OS)	the time from enrollment to documentation of death due to any cause. Subjects who withdraw from study will have their OS time censored on 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.	Up to 2 years
Secondary	Probability of 5 years Participant Survival	the percentage of patients who stay alive till after 5 years from enrollment.	Up to 9 years
Secondary	Progression-free survival by clinical judgment	the time from enrollment to first document of objective tumor progression, or first time tumor progression diagnosed by investigator based on clinical judgment, or death due to any cause, whichever occurs first.	Every 1 to 6 months up to 8 years

External Links

•   To obtain contact information for a study center near you, click here.