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

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ClinicalTrials.gov Identifier: NCT02282059
Recruitment Status : Recruiting
First Posted : November 4, 2014
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pancreatic Neuroendocrine Tumors 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
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : December 12, 2014
Estimated Primary Completion Date : December 12, 2022
Estimated Study Completion Date : December 12, 2022


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




Primary Outcome Measures :
  1. Percentage of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Every 2 to 4 weeks up to 8 years ]
    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.


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Every 1 to 6 months up to 8 years ]
    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.

  2. Overall Survival (OS) [ Time Frame: Up to 2 years ]
    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.

  3. Probability of 5 years Participant Survival [ Time Frame: Up to 9 years ]
    the percentage of patients who stay alive till after 5 years from enrollment.

  4. Progression-free survival by clinical judgment [ Time Frame: Every 1 to 6 months up to 8 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282059


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
China, Anhui
Oncology Department, The Second Affiliated Hospital of Anhui Medical University Active, not recruiting
Hefei, Anhui, China, 230061
China, Beijing
Cancer Institute and Hospital, Chinese Academy of Medical Science Not yet recruiting
Beijing, Beijing, China, 100021
Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences Active, not recruiting
Beijing, Beijing, China, 100021
China, Guangdong
SUN Yat-Sen University Cancer Center Active, not recruiting
Guangzhou, Guangdong, China, 510060
China, Heilongjiang
The Affiliated Tumour Hospital of Harbin Medical University Recruiting
Haerbin, Heilongjiang, China, 150081
China, Henan
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
China, Jiangsu
Nanjing Bayi Hospital Active, not recruiting
Nanjing, Jiangsu, China, 210002
Nanjing General Hospital of Nanjing Military Command/Hepatobiliary Surgery Department Active, not recruiting
Nanjing, Jiangsu, China, 210002
Jiangsu Cancer Hospital Active, not recruiting
Nanjing, Jiangsu, China, 210009
Jiangsu Province Hospital Active, not recruiting
Nanjing, Jiangsu, China, 210029
China, Shannxi
Digestive surgery Department, The First Affiliated Hospital, The Fourth Military Medical University Recruiting
Xi'an, Shannxi, China, 710032
China, Sichuan
West China Hospital of Sichuan University/Hepatobiliary Pancreatic Surgery Recruiting
Chengdu, Sichuan, China, 610041
China, Tianjin
Tianjin Cancer Hospital Active, not recruiting
Tianjin, Tianjin, China, 300060
China, Zhejiang
Zhejiang Cancer Hospital, Oncology department Active, not recruiting
Hangzhou, Zhejiang, China, 310022
China
The PLA of 307 Hospital Active, not recruiting
Beijing, China, 100071
Fudan University Shanghai Cancer Center Active, not recruiting
Shanghai, China, 200032
Tianjin Medical University General Hospital/General Surgery Active, not recruiting
Tianjin, China, 300052
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02282059     History of Changes
Other Study ID Numbers: A6181215
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Neuroendocrine Tumors
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenoma
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors