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

Phase 2CompletedNCT01121562

Pfizer12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Neuroendocrine Tumors

Interventions

SunitinibDRUG

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)

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (4)

Aichi Cancer Center Central Hospital

Nagoya, Aichi-ken, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Osaka Police Hospital

Osaka, Osaka, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Outcomes

Primary Outcomes

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.

Time frame: Up to 799 days of treatment

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 3 years from the last subject registration to the study

Data from ClinicalTrials.gov

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