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

Pancreatic Neuroendocrine Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121562
• Other study ID #: A6181193
• Status: Completed
• Phase: Phase 2
• First received: May 10, 2010
• Last updated: June 18, 2014
• Start date: July 2010
• Est. completion date: November 2013

Study information

• Verified date: June 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Tumor
• Neuroendocrine Tumors
• Pancreatic Neuroendocrine Tumors

Intervention

Drug:
• Sunitinib
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)

Locations

Country	Name	City	State
Japan	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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   To obtain contact information for a study center near you, click here.