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

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Neuroendocrine Tumors
• Intervention / Treatment: Drug: sunitinib

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

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100071
    • Fifth Medical Center of PLA General Hospital
  • Beijing, China, 100071
    • The PLA of 307 Hospital
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital/General Surgery
  • Anhui
    • Hefei, Anhui, China, 230061
      • Oncology Department, The Second Affiliated Hospital of Anhui Medical University
  • Beijing
    • Beijing, Beijing, China, 100021
      • Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
  • Heilongjiang
    • Haerbin, Heilongjiang, China, 150081
      • The Affiliated Tumour Hospital of Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital of Zhengzhou University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Nanjing Bayi Hospital
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Cancer Hospital
    • Nanjing, Jiangsu, China, 210002
      • General Hospital of Eastern Theater Command
    • Nanjing, Jiangsu, China, 210002
      • Nanjing General Hospital of Nanjing Military Command/Hepatobiliary Surgery Department
    • Nanjing, Jiangsu, China, 210002
      • Eastern Theater General Hospital ,QinHuai District Medical Area
  • Shannxi
    • Xi'an, Shannxi, China, 710032
      • Digestive surgery Department, The First Affiliated Hospital, The Fourth Military Medical University
    • Xi'an, Shannxi, China, 710032
      • The First Affiliated Hospital，Air Force Medical University
  • Shanxi
    • Xi'an, Shanxi, China
      • Air Force Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University/Hepatobiliary Pancreatic Surgery
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin cancer hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital, Oncology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The Chinese adult with progressive advanced or metastatic well-differentiated unresectable pancreatic neuroendocrine tumors is the target population.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
sunitinib group; patients with progressive, unresectable, advanced or metastatic well-differentiated pNET	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2014
• Primary Completion (Actual): December 12, 2022
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: October 30, 2014
• First Posted (Estimate): November 4, 2014

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Pancreatic Diseases; Adenoma; Pancreatic Neoplasms; Neuroendocrine Tumors; Adenoma, Islet Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib
• Other Study ID Numbers: A6181215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.