Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the effect of Sunitinib on the clinical benefit response rate.

Official Title
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A Phase II Study Of Sunitinib In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors

Conditions
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Pancreatic Neuroendocrine Tumors

Intervention / Treatment
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* Drug: Sunitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET (Neuroendocrine Tumor) Exclusion Criteria: Patients with poorly differentiated neuroendocrine cancer are not eligible

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sunitinib arm<br> | Drug: Sunitinib<br>* Sunitinib capsule will be given orally at continuous daily dosing with a dose of 37.5 mg in the morning (regardless fasting or non-fasting, One cycle will be 28days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Benefit Response Rate (CBR) | CBR rate is defined as the percentage of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR) ,or stable disease (SD) ≥ 24 weeks. Based on RECIST, CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion. SD is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest dimensions since the treatment started. | Up to 799 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants with a best overall response of confirmed CR or confirmed PR. Based on the response evaluation criteria in solid tumors (RECIST), CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion. | Up to 799 days of treatment | 
| Tumor Shrinkage | Tumor shrinkage is defined as the percent change from baseline for the sum of the longest diameter of target lesions in participants. | Up to 799 days of treatment | 
| Progression-free Survival (PFS) | PFS is defined as the time from registration to first documentation of progressive disease (PD) or to death due to any cause, whichever occurs first. | Up to 799 days of treatment | 
| Overall Survival (OS) | Overall Survival (OS) is defined as the time from registration to documentation of death due to any cause. | Up to 3 years from the last subject registration to the study | 
| Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662). | Reference dose is 37.5 mg. Dose-corrected concentration is calculated from the following formula, observed concentration multiplied by 37.5 over actual dose. SU012662 is an active metabolite of sunitinib. | Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuroendocrine tumors