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

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Oncology Department, The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230061 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pancreatic Neuroendocrine Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02282059
Pfizer
Recruiting
The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors

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Descriptive Information
Brief TitleThe Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors
Official TitleA 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
Brief SummaryThis 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 DescriptionThe 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 TypeObservational
Study DesignObservational Model: Other
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationThe Chinese adult with progressive advanced or metastatic well-differentiated unresectable pancreatic neuroendocrine tumors is the target population.
ConditionPancreatic Neuroendocrine Tumors
InterventionDrug: 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
Study Groups/Cohortssunitinib group
patients with progressive, unresectable, advanced or metastatic well-differentiated pNET
Intervention: Drug: sunitinib
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusRecruiting
Estimated Enrollment
 (submitted: October 30, 2014)
100
Original Estimated EnrollmentSame as current
Estimated Study Completion DateDecember 12, 2022
Estimated Primary Completion DateDecember 12, 2022   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesChina
Removed Location Countries  
 
Administrative Information
NCT NumberNCT02282059
Other Study ID NumbersA6181215
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement
Plan to Share IPD:No
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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2019

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