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

NCT ID: NCT01121562

Last Updated: 2014-06-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-11-30

Brief Summary

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

Detailed Description

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Conditions

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Pancreatic Neuroendocrine Tumors

Keywords

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Neuroendocrine tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sunitinib arm

Group Type EXPERIMENTAL

Sunitinib

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Aichi Cancer Center Central Hospital

Nagoya, Aichi-ken, Japan

Site Status

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Site Status

Osaka Police Hospital

Osaka, Osaka, Japan

Site Status

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 23269537 (View on PubMed)

Related Links

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Other Identifiers

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A6181193

Identifier Type: -

Identifier Source: org_study_id