A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study.

NCT ID: NCT00428220

Last Updated: 2019-06-27

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

NA

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2014-09-30

Brief Summary

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This is a study using sunitinib for patients ending treatment on a previous sunitinib malate protocol to continue to receive sunitinib. The patient must have been enrolled in one of the following studies: A6181030, A6181064, A6181078, A6181087, A6181094, A6181107, A6181108, A6181110, A6181111, A6181112, A6181113, A6181120, A6181126 and A6181170. Other Pfizer sponsored sunitinib studies may be included in the future.

Detailed Description

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Conditions

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Metastatic Breast Cancer Advanced Breast Cancer Metastatic Castration Resistant Prostate Cancer Metastatic Renal Cell Cancer Non-Small Cell Lung Cancer Thyroid Cancer Advanced/Metastatic Non-Small Cell Lung Cancer Advanced Gastric Cancer Gastrointestinal Stromal Tumor Hepatocellular Carcinoma Pancreatic Islet Cell Carcinoma Pancreatic Neuroendocrine Tumor

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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A

Sunitinib will be administered in a continuous daily dose (oral, once per day). Starting dose will be 37.5 mg daily unless the patient was on a different dose (25 mg or 50 mg daily) on the previous trial. In that case, they will begin treatment on this study at the same dose used at the end of the previous study.

The protocol now allows for patients on dosing regimens other than only continuous dosing (e.g. 4/2, etc.) to be enrolled if eligible.

Group Type EXPERIMENTAL

sunitinib

Intervention Type DRUG

sunitinib

Interventions

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sunitinib

sunitinib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must have ended treatment from one of the following sunitinib studies: A6181030, A6181064, A6181078, A6181087, A6181094, A6181107, A6181108, A6181110, A6181111, A6181112, A6181113, A6181120, A6181126 and A6181170. Other Pfizer sponsored sunitinib studies may be included in the future.
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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Emory University, Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

Investigational Drug Service

Atlanta, Georgia, United States

Site Status

The Emory Clinic

Atlanta, Georgia, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Siteman Cancer Center

City of Saint Peters, Missouri, United States

Site Status

Siteman Cancer Center-West County

Creve Coeur, Missouri, United States

Site Status

Barnes Jewish Hospital

St Louis, Missouri, United States

Site Status

Washington University School of Medicine, Siteman Cancer Center

St Louis, Missouri, United States

Site Status

Comprehensive Cancer Center of Nevada

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

Northwest Cancer Specialists, P.C.

Portland, Oregon, United States

Site Status

Northwest Cancer Specialists, P.C.

Portland, Oregon, United States

Site Status

US Oncology Research and Clinical Pharmacy (Drug Shipment Only)

Fort Worth, Texas, United States

Site Status

The Strelitz Diabetes Institute of Eastern Virginia Medical School

Norfolk, Virginia, United States

Site Status

Instituto Oncologico de Cordoba

Nueva Cordoba, Nueva Cordoba, Argentina

Site Status

Clinica Viedma

Viedma, Río Negro Province, Argentina

Site Status

Centro Oncológico Rosario

Rosario, Santa Fe Province, Argentina

Site Status

Centro Medico San Roque

San Miguel de Tucumán, , Argentina

Site Status

Royal Brisbane & Women's Hospital

Herston, Queensland, Australia

Site Status

Royal Adelaide Hospital, Department of Medical Oncology

Adelaide, South Australia, Australia

Site Status

Austin Health

Heidelberg, Victoria, Australia

Site Status

Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

Mount Medical Centre

Perth, Western Australia, Australia

Site Status

Hopital Erasme / Gastroenterologie

Brussels, , Belgium

Site Status

Cliniques Universitaires Saint Luc / Gastroentérologie

Brussels, , Belgium

Site Status

Cliniques Universitaires Saint-Luc, Oncologie

Brussels, , Belgium

Site Status

UZ Gasthuisberg, Department Internal Medicine - Gastroenterology - Gastro-intestinal Oncology

Leuven, , Belgium

Site Status

Centre Hospitalier Universitaire de Liege

Liège, , Belgium

Site Status

Algemeen Ziekenhuis Nikolaas

Sint-Niklaas, , Belgium

Site Status

AZ Sint-Augustinus, Oncologisch Centrum

Wilrijk, , Belgium

Site Status

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Centro de Oncologia do Instituto de Radiologia

São Paulo, São Paulo, Brazil

Site Status

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

São Paulo, São Paulo, Brazil

Site Status

BC Cancer Agency - Vancouver Centre

Vancouver, British Columbia, Canada

Site Status

QEII Health Sciences Centre - Nova Scotia Cancer Centre

Halifax, Nova Scotia, Canada

Site Status

QEII Health Sciences Centre - Victoria General Site

Halifax, Nova Scotia, Canada

Site Status

QEII Health Sciences Centre - Halifax Infirmary Site

Halifax, Nova Scotia, Canada

Site Status

London Regional Cancer Program

London, Ontario, Canada

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

CHUM, Hopital Saint-Luc

Montreal, Quebec, Canada

Site Status

Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status

Fundacion Centro de Investigacion Clinica CIC

Medellín, Anquioquia, Colombia

Site Status

Hospital Universitario San Vicente de Paul

Medellín, Antioquia, Colombia

Site Status

Clinica Astorga

Medellín, Antioquia, Colombia

Site Status

Centre Antoine Lacassagne

Nice, Cedex 02, France

Site Status

Hopital Beaujon

Clichy, Cedex, France

Site Status

Groupe Hospitalier Cochin, Cancer Quest AP-HP

Paris, Cedex, France

Site Status

CHU-Hôpital Jean Minjoz

Besançon, , France

Site Status

Hopital Saint-Andre

Bordeaux, , France

Site Status

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Polyclinique du Bois

Lille, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

Centre Leon Berard

Lyon, , France

Site Status

Hopital Edouard Herriot

Lyon, , France

Site Status

Chu La Timone

Marseille, , France

Site Status

Clinique Hartmann

Neuilly-sur-Seine, , France

Site Status

Hopital Saint-Antoine

Paris, , France

Site Status

Centre Eugene Marquis

Rennes, , France

Site Status

Klinik fuer Innere Medizin, Gastroenterologie, Onkologie, Endokrinologie

Bad Berka, , Germany

Site Status

Universitaetsklinikum Charité, Campus Virchow Klinikum

Berlin, , Germany

Site Status

eps - early phase GmbH

Jena, , Germany

Site Status

Frauenaerzte Pruener Gang

Kiel, , Germany

Site Status

Klinik fuer Frauenheilkunde und Geburtshilfe, Universitaetsklinikum Schleswig-Holstein

Lübeck, , Germany

Site Status

Universitaetsklinikum Schleswig-Holstein, Campus Luebeck

Lübeck, , Germany

Site Status

Universitaetsklinikum Giessen und Marburg, Standort Marburg

Marburg, , Germany

Site Status

Rhoen Klinikum Meiningen, Gynaekologie und Geburtshilfe

Meiningen, , Germany

Site Status

Frauenklinik und Poliklinik, Klinikum rechts der Isar, Technische Universitaet Muenchen

München, , Germany

Site Status

Department of Clinical Oncology, Tuen Mun Hospital

Tuenmen, New Territories, Hong Kong

Site Status

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Division of Haematology/Oncology, Department of Medicine, Queen Mary Hospital,

Hong Kong, , Hong Kong

Site Status

Queen Elizabeth Hospital, Department of Clinical Oncology

Kowloon, , Hong Kong

Site Status

Tuen Mun Hospital, Department of Clinical Oncology

Tuen Mun, New Territories, , Hong Kong

Site Status

UNIMED Medical Institute

Wan Chai, , Hong Kong

Site Status

Hospital Universitario Dr. Jose Eleuterio Gonzalez Centro Universitario contra el cancer

Monterrey, Nuevo León, Mexico

Site Status

Hospital Christus Muguerza del Parque

Chihuahua City, , Mexico

Site Status

Cancer Care Clinic

Quezon City, Metro Manila, , Philippines

Site Status

National University Hospital/Department of Heamatology-Oncology

Singapore, , Singapore

Site Status

National Cancer Center/Department of Medical Oncology

Singapore, , Singapore

Site Status

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Seoul National University Hospital / Department of Internal Medecine

Seoul, Republic of Korea, South Korea

Site Status

Asan Medical Center, Division of Oncology, Department of Internal Medicine

Seoul, Republic of Korea, South Korea

Site Status

Yeungnam University Medical Center/Department of Internal medicine

Daegu, , South Korea

Site Status

Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

Site Status

Fundacion Hospital Alcorcon

Alcorcón, Madrid, Spain

Site Status

Complexo Hospitalario Universitario A Coruña

A Coruña, , Spain

Site Status

Servicio de Oncologia

Barcelona, , Spain

Site Status

Centro Oncologico Md Anderson International España

Madrid, , Spain

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Hospital 12 de Octubre

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Chi Mei Medical Center, Liouying

Liouying Township, Tainan,, Taiwan, Taiwan

Site Status

Chi-Mei Medical Center

YungKang City, Tainan, Taiwan, Taiwan

Site Status

Chang Gung Medical Foundation, Linkou Branch

Guishanli, Taoyuan, Taiwan

Site Status

Changhua Christian Hospital

Changhua, , Taiwan

Site Status

Chung-Ho Memorial Hospital, Kaohsiung Medical University/Department of Surgery

Kaohsiung City, , Taiwan

Site Status

Taichung Veterans General Hospital, Department of Surgery

Taichung, , Taiwan

Site Status

National Taiwan University Hospital/Department of Oncology

Taipei, , Taiwan

Site Status

Koo Foundation Sun Yat-Sen Cancer Center, Div. of Hematology/Oncology

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Division of Surgery and Oncology

Liverpool, Merseyside, United Kingdom

Site Status

Deparment of Cardiology

Glasgow, , United Kingdom

Site Status

The Beatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

Site Status

Dainton Building

Leeds, , United Kingdom

Site Status

St James' Institute of Oncology

Leeds, , United Kingdom

Site Status

Management Offices, 4th Floor, Thomas Guy House

London, , United Kingdom

Site Status

Royal Marsden Hospital

London, , United Kingdom

Site Status

Department of Medical Oncology

Manchester, , United Kingdom

Site Status

Cardiology Department, Wythenshawe Hospital

Manchester, , United Kingdom

Site Status

Nottingham City Hospital

Nottingham, , United Kingdom

Site Status

Countries

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United States Argentina Australia Belgium Brazil Canada Colombia France Germany Hong Kong Mexico Philippines Singapore South Korea Spain Taiwan United Kingdom

Related Links

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Other Identifiers

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2006-006538-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A6181114

Identifier Type: -

Identifier Source: org_study_id

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