The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors
- Registration Number
- NCT02282059
- Lead Sponsor
- Pfizer
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description sunitinib group sunitinib patients with progressive, unresectable, advanced or metastatic well-differentiated pNET
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related) From baseline up to 8 years 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.
Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related) From baseline up to 8 years 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.
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 From baseline up to 8 years 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.
- Secondary Outcome Measures
Name Time Method Five-Year Survival Rate From baseline up to 8 years Five-year survival rate was defined as the proportion of participants who stayed alive till after 5 years from the start of sunitinib treatment.
Overall Survival (OS) From baseline up to 8 years OS was defined as the time from the start of sunitinib treatment to documentation of death due to any cause.
Progression-Free Survival (PFS) From baseline up to 8 years 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.
Progression-Free Survival by Clinical Judgment From baseline up to 8 years 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.
Trial Locations
- Locations (24)
The Affiliated Tumour Hospital of Harbin Medical University
🇨🇳Haerbin, Heilongjiang, China
Eastern Theater General Hospital,QinHuai District Medical Area
🇨🇳Nanjing, Jiangsu, 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
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
SUN Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Nanjing Bayi Hospital
🇨🇳Nanjing, Jiangsu, China
West China Hospital of Sichuan University/Hepatobiliary Pancreatic Surgery
🇨🇳Chengdu, Sichuan, China
Tianjin Cancer Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University General Hospital/General Surgery
🇨🇳Tianjin, China
Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Oncology Department, The Second Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The PLA of 307 Hospital
🇨🇳Beijing, China
General Hospital of Eastern Theater Command
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Nanjing General Hospital of Nanjing Military Command/Hepatobiliary Surgery Department
🇨🇳Nanjing, Jiangsu, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital，Air Force Medical University
🇨🇳Xi'an, Shannxi, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Fifth Medical Center of PLA General Hospital
🇨🇳Beijing, China
Zhejiang Cancer Hospital, Oncology department
🇨🇳Hangzhou, Zhejiang, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China