Clinical trial NCT02282059: The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neuroendocrine Tumors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-11-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-related)
timeFrame: From baseline up to 8 years
measure: Number of Participants With Serious Adverse Events (SAEs) (All Causalities and Treatment-related)
timeFrame: From baseline up to 8 years
measure: 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
timeFrame: From baseline up to 8 years
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From baseline up to 8 years
measure: Progression-Free Survival by Clinical Judgment
timeFrame: From baseline up to 8 years
measure: Overall Survival (OS)
timeFrame: From baseline up to 8 years
measure: Five-Year Survival Rate
timeFrame: From baseline up to 8 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: Oncology Department, The Second Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Guangzhou
country: China
facility: SUN Yat-Sen University Cancer Center
state: Guangdong
city: Haerbin
country: China
facility: The Affiliated Tumour Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Nanjing
country: China
facility: Eastern Theater General Hospital,QinHuai District Medical Area
state: Jiangsu
city: Nanjing
country: China
facility: General Hospital of Eastern Theater Command
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Bayi Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing General Hospital of Nanjing Military Command/Hepatobiliary Surgery Department
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Xi'an
country: China
facility: Digestive surgery Department, The First Affiliated Hospital, The Fourth Military Medical University
state: Shannxi
city: Xi'an
country: China
facility: The First Affiliated Hospital，Air Force Medical University
state: Shannxi
city: Xi'an
country: China
facility: Air Force Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University/Hepatobiliary Pancreatic Surgery
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital, Oncology department
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Beijing
country: China
facility: Fifth Medical Center of PLA General Hospital
city: Beijing
country: China
facility: The PLA of 307 Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital/General Surgery
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: