Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Sunitinib In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors|
- Clinical Benefit Response Rate (CBR) [ Time Frame: 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.
- Objective Response Rate (ORR) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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). [ Time Frame: 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.
|Study Start Date:||July 2010|
|Study Completion Date:||November 2013|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
|Experimental: Sunitinib arm||
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121562
|Aichi Cancer Center Central Hospital|
|Nagoya, Aichi, Japan|
|National Cancer Center Hospital|
|Chuo-ku, Tokyo, Japan|
|Kyushu University Hospital|
|Osaka Police Hospital|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|