Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Neuroendocrine Tumors

Adenoma

Adenoma, Islet Cell

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neoplasms, Glandular and Epithelial

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Neuroepithelioma

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

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)

Pfizer CT.gov Call Center

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

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

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

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.

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 is defined as the percent change from baseline for the sum of the longest diameter of target lesions in participants.

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) is defined as the time from registration to documentation of death due to any cause.

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.

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).

Age, Continuous

Sex: Female, Male

Pfizer ClinicalTrials.gov Call Center

Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.

Clinical Benefit Response Rate (CBR)

Objective Response Rate (ORR)

Cycle 1 (n=1)

Cycle 2 (n=11)

Cycle 3 (n=12)

Cycle 5 (n=9)

Cycle 7 (n=9)

Cycle 9 (n=9)

Cycle 11 (n=9)

Cycle 13 (n=9)

Cycle 14 (n=1)

Cycle 15 (n=7)

Cycle 16 (n=1)

Cycle 17 (n=5)

Cycle 18 (n=1)

Cycle 19 (n=4)

Cycle 21 (n=4)

Cycle 23 (n=4)

Cycle 25 (n=4)

Cycle 27 (n=3)

Cycle 28 (n=2)

Cycle 29 (n=1)

Maximum Reduction (n=12)

Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication. "n " in the measured values means number of participants analyzed in the cycle.

Tumor Shrinkage

Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.

Median PFS had not yet been reached due to short of events.

Progression-free Survival (PFS)

Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.

OS was not analyzed due to short of events.

Overall Survival (OS)

Sunitinib (Cycle 1 Day 15, n=10)

Sunitinib (Cycle 2 Day 1, n=2)

Sunitinib (Cycle 3 Day 1, n=8)

Sunitinib (Cycle 4 Day 1, n=5)

SU012662 (Cycle 1 Day 15, n=10)

SU012662 (Cycle 2 Day 1, n=2)

SU012662 (Cycle 3 Day 1, n=8)

SU012662 (Cycle 4 Day 1, n=5)

Total drug (Cycle 1 Day 15, n=10)

Total drug (Cycle 2 Day 1, n=2)

Total drug (Cycle 3 Day 1, n=8)

Total drug (Cycle 4 Day 1, n=5)

The pharmacokinetics analysis set was defined as all participants who had at least one plasma concentration data at trough sampling with steady-state condition. "n" in the measured values means number of participants analyzed.

Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662).

Overall Study

Spots Global Cancer Trial Database for Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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