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

Primary Purpose

Pancreatic Neuroendocrine Tumors

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Sunitinib
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neuroendocrine Tumors focused on measuring Neuroendocrine tumors

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aichi Cancer Center Central Hospital
  • National Cancer Center Hospital
  • Kyushu University Hospital
  • Osaka Police Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sunitinib arm

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Tumor Shrinkage
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)
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)
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).
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.

Full Information

First Posted
May 10, 2010
Last Updated
June 18, 2014
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01121562
Brief Title
Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
Official Title
A Phase II Study Of Sunitinib In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neuroendocrine Tumors
Keywords
Neuroendocrine tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sunitinib arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Intervention Description
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)
Primary Outcome Measure Information:
Title
Clinical Benefit Response Rate (CBR)
Description
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.
Time Frame
Up to 799 days of treatment
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
Up to 799 days of treatment
Title
Tumor Shrinkage
Description
Tumor shrinkage is defined as the percent change from baseline for the sum of the longest diameter of target lesions in participants.
Time Frame
Up to 799 days of treatment
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
Up to 799 days of treatment
Title
Overall Survival (OS)
Description
Overall Survival (OS) is defined as the time from registration to documentation of death due to any cause.
Time Frame
Up to 3 years from the last subject registration to the study
Title
Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662).
Description
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.
Time Frame
Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Aichi Cancer Center Central Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
Country
Japan
Facility Name
Osaka Police Hospital
City
Osaka
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
23269537
Citation
Ito T, Okusaka T, Nishida T, Yamao K, Igarashi H, Morizane C, Kondo S, Mizuno N, Hara K, Sawaki A, Hashigaki S, Kimura N, Murakami M, Ohki E, Chao RC, Imamura M. Phase II study of sunitinib in Japanese patients with unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumor. Invest New Drugs. 2013 Oct;31(5):1265-74. doi: 10.1007/s10637-012-9910-y. Epub 2012 Dec 27. Erratum In: Invest New Drugs. 2019 Jun;37(3):591.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181193&StudyName=Efficacy%20And%20Safety%20Of%20Sunitinib%20In%20Patients%20With%20Advanced%20Well-Differentiated%20Pancreatic%20Neuroendocrine%20Tumors
Description
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Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors

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