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

Phase 2

Completed

• Conditions: Pancreatic Neuroendocrine Tumors
• Interventions: Drug: Sunitinib

• Registration Number: NCT01121562
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-10
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-12
• Study Start: 2010-07
• Primary Completion: 2011-07
• Results First Submitted: 2012-07-01
• Results First Submitted QC: 2012-07-05
• Results First Posted: 2012-08-27
• Study Completion: 2013-11
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-18
• Last Update Posted: 2014-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sunitinib arm	Sunitinib	-

Primary Outcome Measures

Name	Time	Method
Clinical Benefit Response Rate (CBR)	Up to 799 days of treatment	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.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to 799 days of treatment	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.
Tumor Shrinkage	Up to 799 days of treatment	Tumor shrinkage is defined as the percent change from baseline for the sum of the longest diameter of target lesions in participants.
Progression-free Survival (PFS)	Up to 799 days of treatment	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.
Overall Survival (OS)	Up to 3 years from the last subject registration to the study	Overall Survival (OS) is defined as the time from registration to documentation of death due to any cause.
Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662).	Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1	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.

Trial Locations

Locations (4)

National Cancer Center Hospital; 🇯🇵 Chuo-ku, Tokyo, Japan

Kyushu University Hospital; 🇯🇵 Fukuoka, Japan

Aichi Cancer Center Central Hospital; 🇯🇵 Nagoya, Aichi, Japan

Osaka Police Hospital; 🇯🇵 Osaka, Japan