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: June 2024
• 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	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related)	An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product. The event did not necessarily need to have a causal relationship with the product treatment or usage. A TEAE was defined as an event that emerged during treatment, having been absent pretreatment, or worsened relative to the pretreatment state.	From baseline up to 8 years
Primary	Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related)	An SAE was any untoward medical occurrence in a participant administered a medicinal at any dose that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect.	From baseline up to 8 years
Primary	Number of Participants With Hematology/Chemistry/Urinalysis Laboratories of Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade =2 at Baseline That Shifted to a Maximum CTCAE Grade 3 or 4	Laboratory abnormalities assessment included: hematologic: hemoglobin, platelet count, white blood cell (WBC) count, neutrophile granulocyte count; non-hematologic: total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, gamma-glutamyl transferase (GGT), total protein, albumin, blood urea nitrogen (BUN), creatinine, uric acid, glucose, hypocalcemia, hyponatremia, hypophosphatemia, hypokalaemia.	From baseline up to 8 years
Secondary	Progression-Free Survival (PFS)	Investigator assessed PFS according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.6. PFS was defined as the time from the start of sunitinib treatment to first document of objective tumor progression or death due to any cause, whichever occurred first. Progression was defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	From baseline up to 8 years
Secondary	Progression-Free Survival by Clinical Judgment	PFS by clinical judgment was defined as the time from the start of sunitinib treatment 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 occurred first. Progression was defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	From baseline up to 8 years
Secondary	Overall Survival (OS)	OS was defined as the time from the start of sunitinib treatment to documentation of death due to any cause.	From baseline up to 8 years
Secondary	Five-Year Survival Rate	Five-year survival rate was defined as the proportion of participants who stayed alive till after 5 years from the start of sunitinib treatment.	From baseline up to 8 years

External Links

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