NCT01121562

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2010

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 27, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

June 30, 2014

Status Verified

June 1, 2014

Enrollment Period

1 year

First QC Date

May 10, 2010

Results QC Date

July 1, 2012

Last Update Submit

June 18, 2014

Conditions

Pancreatic Neuroendocrine Tumors

Keywords

Neuroendocrine tumors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Objective Response Rate (ORR)

    Up to 799 days of treatment

  • Tumor Shrinkage

    Up to 799 days of treatment

  • Progression-free Survival (PFS)

    Up to 799 days of treatment

  • Overall Survival (OS)

    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).

    Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1

Study Arms (1)

Sunitinib arm

EXPERIMENTAL
Drug: Sunitinib

Interventions

SunitinibDRUG

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)

Sunitinib arm

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET (Neuroendocrine Tumor)

You may not qualify if:

  • Patients with poorly differentiated neuroendocrine cancer are not eligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Aichi Cancer Center Central Hospital

Nagoya, Aichi-ken, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Location

Osaka Police Hospital

Osaka, Osaka, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 23269537DERIVED

Related Links

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 12, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2011

Study Completion

November 1, 2013

Last Updated

June 30, 2014

Results First Posted

August 27, 2012

Record last verified: 2014-06

Locations

JP(4)