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 21, 2019
|Condition or disease||Intervention/treatment|
|Pancreatic Neuroendocrine Tumors||Drug: sunitinib|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
patients with progressive, unresectable, advanced or metastatic well-differentiated pNET
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
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|