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

NCT ID: NCT01525550

Last Updated: 2019-07-30

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

PHASE4

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-06

Study Completion Date

2018-07-26

Brief Summary

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The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with unresectable pancreatic neuroendocrine tumors.

Detailed Description

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This study is being conducted to meet regulatory post-marketing commitments.

Conditions

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Well-differentiated Pancreatic Neuroendocrine Tumor

Study Design

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Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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sunitinib

Group Type EXPERIMENTAL

sunitinib

Intervention Type DRUG

Sunitinib capsules will be given orally at continuous daily dosing with a starting dose of 37.5 mg. One cycle is equal to 28 days.

Interventions

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sunitinib

Sunitinib capsules will be given orally at continuous daily dosing with a starting dose of 37.5 mg. One cycle is equal to 28 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically proven diagnosis of well-differentiated pancreatic neuroendocrine tumor (according to World Health Organization \[WHO 2000\] classification).
* Disease progression within 12 months prior to study enrollment.
* Disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent.

Exclusion Criteria

* Patients with poorly differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification).
* Prior treatment with any tyrosine kinase inhibitors, anti vascular endothelial growth factor (VEGF) angiogenesis inhibitors, non VEGF targeted angiogenesis inhibitors, or mammalian target of rapamycin (mTOR) inhibitors.
Minimum Eligible Age

18 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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Univeristy of California

Orange, California, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Barwon Health - University Hospital Geelong

Geelong, Victoria, Australia

Site Status

Cliniques Universitaires Saint-Luc, Gastroenterologie

Brussels, Brussels Gewest, Belgium

Site Status

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status

307 Hospital of PLA

Beijing, Beijing Municipality, China

Site Status

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Nanjing Bayi Hospital

Nanjing, Jiangsu, China

Site Status

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status

Zhongshan Hospital Fudan University

Shanghai, , China

Site Status

Masarykuv onkologicky ustav

Brno, , Czechia

Site Status

Fakultni poliklinika

Prague, , Czechia

Site Status

Vseobecna Fakultni Nemocnice v Praze

Prague, , Czechia

Site Status

Hôpital Beaujon

Clichy, , France

Site Status

Semmelweis Egyetem/II. Sz. Belgyogyaszati Klinika

Budapest, , Hungary

Site Status

Tata Memorial Hospital

Mumbai, Maharashtra, India

Site Status

IEO Istituto Europeo di Oncologia, IRCCS

Milan, , Italy

Site Status

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Site Status

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Site Status

Oslo Universitetssykehus HF, Rikshospitalet

Oslo, , Norway

Site Status

Centrul de Oncologie Sf. Nectarie

Craiova, Dolj, Romania

Site Status

Institutul Clinic Fundeni, Centrul de Gastroenterologie si Hepatologie

Bucharest, , Romania

Site Status

Narodny Onkologicky ustav

Bratislava, , Slovakia

Site Status

Wits Clinical Research

Johannesburg, Gauteng, South Africa

Site Status

Hospital Universitario Madrid Sanchinarro - Centro Integral Oncológico Clara Campal (CIOCC)

Madrid, , Spain

Site Status

Countries

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United States Australia Belgium China Czechia France Hungary India Italy Japan Norway Romania Slovakia South Africa Spain

References

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Fazio N, Kulke M, Rosbrook B, Fernandez K, Raymond E. Updated Efficacy and Safety Outcomes for Patients with Well-Differentiated Pancreatic Neuroendocrine Tumors Treated with Sunitinib. Target Oncol. 2021 Jan;16(1):27-35. doi: 10.1007/s11523-020-00784-0. Epub 2021 Jan 7.

Reference Type DERIVED
PMID: 33411058 (View on PubMed)

Related Links

Other Identifiers

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2011-004363-74

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A6181202

Identifier Type: -

Identifier Source: org_study_id

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