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2010-07
2011-07
2013-11
12
NCT01121562
Pfizer
Pfizer
INTERVENTIONAL
Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
The purpose of the study is to evaluate the effect of Sunitinib on the clinical benefit response rate.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2010-05-10 | 2012-07-01 | 2014-06-18 |
2010-05-10 | 2012-07-05 | 2014-06-30 |
2010-05-12 | 2012-08-27 | 2014-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Sunitinib arm | DRUG: Sunitinib
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
