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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Pancreatic Neuroendocrine Tumors

Intervention / Treatment
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* Drug: sunitinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sunitinib group<br>patients with progressive, unresectable, advanced or metastatic well-differentiated pNET | Drug: sunitinib<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 <X> days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Every 2 to 4 weeks up to 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Probability of 5 years Participant Survival | the percentage of patients who stay alive till after 5 years from enrollment. | Up to 9 years | 
| 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 |