Clinical trial NCT00428220: A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study.
Official title: An Open-label Sunitinib Malate (su011248) Continuation Protocol For Patients Who Have Completed A Prior Sunitinib Study And Are Judged By The Investigator To Have The Potential To Benefit From Sunitinib Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: Potentially other tumor types in the future
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-29
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Exclusion Criteria:

* See inclusion criteria

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities)
timeFrame: From first day of treatment on the current study up to 28 days post the last dose of study treatment
measure: Number of Participants With Treatment-emergent AEs (Treatment-Related)
timeFrame: From first day of treatment on the current study up to 28 days post the last dose of study treatment
Secondary outcomes:
Other outcomes:
measure: Summary of Duration of Clinical Benefit
timeFrame: From the first day of treatment in parent study until last day of treatment in A6181114 study.
Locations:
city: Atlanta
country: United States
facility: Emory University, Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Investigational Drug Service
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Creve Coeur
country: United States
facility: Siteman Cancer Center-West County
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine, Siteman Cancer Center
state: Missouri
city: Saint Peters
country: United States
facility: Siteman Cancer Center
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Center of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Fort Worth
country: United States
facility: US Oncology Research and Clinical Pharmacy (Drug Shipment Only)
state: Texas
city: Norfolk
country: United States
facility: The Strelitz Diabetes Institute of Eastern Virginia Medical School
state: Virginia
city: Viedma
country: Argentina
facility: Clinica Viedma
state: Rio Negro
city: Rosario
country: Argentina
facility: Centro Oncológico Rosario
state: Santa Fé
city: Nueva Cordoba
country: Argentina
facility: Instituto Oncologico de Cordoba
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico San Roque
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital, Department of Medical Oncology
state: South Australia
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Perth
country: Australia
facility: Mount Medical Centre
state: Western Australia
city: Bruxelles
country: Belgium
facility: Hopital Erasme / Gastroenterologie
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint Luc / Gastroentérologie
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc, Oncologie
city: Leuven
country: Belgium
facility: UZ Gasthuisberg, Department Internal Medicine - Gastroenterology - Gastro-intestinal Oncology
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege
city: Sint-Niklaas
country: Belgium
facility: Algemeen Ziekenhuis Nikolaas
city: Wilrijk
country: Belgium
facility: AZ Sint-Augustinus, Oncologisch Centrum
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: RS
city: Sao Paulo
country: Brazil
facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes
state: SP
city: São Paulo
country: Brazil
facility: Centro de Oncologia do Instituto de Radiologia
state: SP
city: Vancouver
country: Canada
facility: BC Cancer Agency - Vancouver Centre
state: British Columbia
city: Halifax
country: Canada
facility: QEII Health Sciences Centre - Nova Scotia Cancer Centre
state: Nova Scotia
city: Halifax
country: Canada
facility: QEII Health Sciences Centre - Victoria General Site
state: Nova Scotia
city: Halifax
country: Canada
facility: QEII Health Sciences Centre - Halifax Infirmary Site
state: Nova Scotia
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: CHUM, Hopital Saint-Luc
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Medellin
country: Colombia
facility: Fundacion Centro de Investigacion Clinica CIC
state: Anquioquia
city: Medellin
country: Colombia
facility: Hospital Universitario San Vicente de Paul
state: Antioquia
city: Medellin
country: Colombia
facility: Clinica Astorga
state: Antioquia
city: Nice
country: France
facility: Centre Antoine Lacassagne
state: Cedex 02
city: Clichy Cedex
country: France
facility: Hopital Beaujon
state: Cedex
city: Paris
country: France
facility: Groupe Hospitalier Cochin, Cancer Quest AP-HP
state: Cedex
city: Besancon
country: France
facility: CHU-Hôpital Jean Minjoz
city: Bordeaux Cedex
country: France
facility: Hopital Saint-Andre
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Lille
country: France
facility: Polyclinique du Bois
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon Cedex 03
country: France
facility: Hopital Edouard Herriot
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille Cedex 5
country: France
facility: Chu La Timone
city: Neuilly Sur Seine
country: France
facility: Clinique Hartmann
city: Paris
country: France
facility: Hopital Saint-Antoine
city: Rennes Cedex
country: France
facility: Centre Eugene Marquis
city: Bad Berka
country: Germany
facility: Klinik fuer Innere Medizin, Gastroenterologie, Onkologie, Endokrinologie
city: Berlin
country: Germany
facility: Universitaetsklinikum Charité, Campus Virchow Klinikum
city: Jena
country: Germany
facility: eps - early phase GmbH
city: Kiel
country: Germany
facility: Frauenaerzte Pruener Gang
city: Luebeck
country: Germany
facility: Klinik fuer Frauenheilkunde und Geburtshilfe, Universitaetsklinikum Schleswig-Holstein
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein, Campus Luebeck
city: Marburg
country: Germany
facility: Universitaetsklinikum Giessen und Marburg, Standort Marburg
city: Meiningen
country: Germany
facility: Rhoen Klinikum Meiningen, Gynaekologie und Geburtshilfe
city: Muenchen
country: Germany
facility: Frauenklinik und Poliklinik, Klinikum rechts der Isar, Technische Universitaet Muenchen
city: Tuen Mun
country: Hong Kong
facility: Department of Clinical Oncology, Tuen Mun Hospital
state: New Territories
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: Division of Haematology/Oncology, Department of Medicine, Queen Mary Hospital,
city: Kowloon
country: Hong Kong
facility: Queen Elizabeth Hospital, Department of Clinical Oncology
city: Tuen Mun, New Territories
country: Hong Kong
facility: Tuen Mun Hospital, Department of Clinical Oncology
city: Wan Chai,
country: Hong Kong
facility: UNIMED Medical Institute
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital / Department of Internal Medecine
state: Republic Of Korea
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Division of Oncology, Department of Internal Medicine
state: Republic Of Korea
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center/Department of Internal medicine
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez Centro Universitario contra el cancer
state: Nuevo Leon
city: Chihuahua
country: Mexico
facility: Hospital Christus Muguerza del Parque
city: Quezon City, Metro Manila
country: Philippines
facility: Cancer Care Clinic
city: Singapore
country: Singapore
facility: National University Hospital/Department of Heamatology-Oncology
city: Singapore
country: Singapore
facility: National Cancer Center/Department of Medical Oncology
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: Alcorcon
country: Spain
facility: Fundacion Hospital Alcorcon
state: Madrid
city: Barcelona
country: Spain
facility: Servicio de Oncologia
city: La Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
city: Madrid
country: Spain
facility: Centro Oncologico Md Anderson International España
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Kuei-Shan
country: Taiwan
facility: Chang Gung Medical Foundation, Linkou Branch
state: Taoyuan
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Chung-Ho Memorial Hospital, Kaohsiung Medical University/Department of Surgery
city: Liouying Township, Tainan,
country: Taiwan
facility: Chi Mei Medical Center, Liouying
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital, Department of Surgery
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital/Department of Oncology
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center, Div. of Hematology/Oncology
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: YungKang City, Tainan
country: Taiwan
facility: Chi-Mei Medical Center
city: Liverpool
country: United Kingdom
facility: Division of Surgery and Oncology
state: Merseyside
city: Glasgow
country: United Kingdom
facility: Deparment of Cardiology
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre
city: Leeds
country: United Kingdom
facility: Dainton Building
city: Leeds
country: United Kingdom
facility: St James' Institute of Oncology
city: London
country: United Kingdom
facility: Management Offices, 4th Floor, Thomas Guy House
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Manchester
country: United Kingdom
facility: Department of Medical Oncology
city: Manchester
country: United Kingdom
facility: Cardiology Department, Wythenshawe Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: