A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study.
- Conditions
- Pancreatic Islet Cell CarcinomaAdvanced/Metastatic Non-Small Cell Lung CancerMetastatic Breast CancerAdvanced Breast CancerThyroid CancerHepatocellular CarcinomaMetastatic Castration Resistant Prostate CancerMetastatic Renal Cell CancerNon-Small Cell Lung CancerAdvanced Gastric Cancer
- Interventions
- Registration Number
- NCT00428220
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 223
- 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.
- See inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A sunitinib 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent AEs (Treatment-Related) From first day of treatment on the current study up to 28 days post the last dose of study treatment Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.
Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) From first day of treatment on the current study up to 28 days post the last dose of study treatment Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (112)
Chi-Mei Medical Center
🇨🇳YungKang City, Tainan, Taiwan
Fundacion Centro de Investigacion Clinica CIC
🇨🇴Medellin, Anquioquia, Colombia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Clinica Viedma
🇦🇷Viedma, Rio Negro, Argentina
CHUM, Hopital Saint-Luc
🇨🇦Montreal, Quebec, Canada
Koo Foundation Sun Yat-Sen Cancer Center, Div. of Hematology/Oncology
🇨🇳Taipei, Taiwan
Hospital Universitario Dr. Jose Eleuterio Gonzalez Centro Universitario contra el cancer
🇲🇽Monterrey, Nuevo Leon, Mexico
Division of Haematology/Oncology, Department of Medicine, Queen Mary Hospital,
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
QEII Health Sciences Centre - Halifax Infirmary Site
🇨🇦Halifax, Nova Scotia, Canada
Corporacio Sanitaria Parc Tauli
🇪🇸Sabadell, Barcelona, Spain
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Comprehensive Cancer Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Royal Brisbane & Women's Hospital
🇦🇺Herston, Queensland, Australia
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
US Oncology Research and Clinical Pharmacy (Drug Shipment Only)
🇺🇸Fort Worth, Texas, United States
Cliniques Universitaires Saint Luc / Gastroentérologie
🇧🇪Bruxelles, Belgium
The Emory Clinic
🇺🇸Atlanta, Georgia, United States
Northwest Cancer Specialists, P.C.
🇺🇸Portland, Oregon, United States
Washington University School of Medicine, Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
Emory University, Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Centro Medico San Roque
🇦🇷San Miguel de Tucuman, Argentina
Siteman Cancer Center-West County
🇺🇸Creve Coeur, Missouri, United States
Royal Adelaide Hospital, Department of Medical Oncology
🇦🇺Adelaide, South Australia, Australia
Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Centro Oncológico Rosario
🇦🇷Rosario, Santa Fé, Argentina
Investigational Drug Service
🇺🇸Atlanta, Georgia, United States
Instituto Oncologico de Cordoba
🇦🇷Nueva Cordoba, Argentina
Mount Medical Centre
🇦🇺Perth, Western Australia, Australia
Hopital Erasme / Gastroenterologie
🇧🇪Bruxelles, Belgium
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
UZ Gasthuisberg, Department Internal Medicine - Gastroenterology - Gastro-intestinal Oncology
🇧🇪Leuven, Belgium
Centro de Oncologia do Instituto de Radiologia
🇧🇷São Paulo, SP, Brazil
AZ Sint-Augustinus, Oncologisch Centrum
🇧🇪Wilrijk, Belgium
Hopital Beaujon
🇫🇷Clichy Cedex, Cedex, France
Groupe Hospitalier Cochin, Cancer Quest AP-HP
🇫🇷Paris, Cedex, France
eps - early phase GmbH
🇩🇪Jena, Germany
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
🇧🇷Sao Paulo, SP, Brazil
QEII Health Sciences Centre - Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Cliniques Universitaires Saint-Luc, Oncologie
🇧🇪Bruxelles, Belgium
Clinica Astorga
🇨🇴Medellin, Antioquia, Colombia
BC Cancer Agency - Vancouver Centre
🇨🇦Vancouver, British Columbia, Canada
QEII Health Sciences Centre - Victoria General Site
🇨🇦Halifax, Nova Scotia, Canada
Centre Hospitalier Universitaire de Liege
🇧🇪Liege, Belgium
Algemeen Ziekenhuis Nikolaas
🇧🇪Sint-Niklaas, Belgium
Hospital Universitario San Vicente de Paul
🇨🇴Medellin, Antioquia, Colombia
Hospital Christus Muguerza del Parque
🇲🇽Chihuahua, Mexico
Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
Klinik fuer Frauenheilkunde und Geburtshilfe, Universitaetsklinikum Schleswig-Holstein
🇩🇪Luebeck, Germany
CHU-Hôpital Jean Minjoz
🇫🇷Besancon, France
Universitaetsklinikum Charité, Campus Virchow Klinikum
🇩🇪Berlin, Germany
Centre Antoine Lacassagne
🇫🇷Nice, Cedex 02, France
Hopital Edouard Herriot
🇫🇷Lyon Cedex 03, France
Chu La Timone
🇫🇷Marseille Cedex 5, France
Klinik fuer Innere Medizin, Gastroenterologie, Onkologie, Endokrinologie
🇩🇪Bad Berka, Germany
Frauenaerzte Pruener Gang
🇩🇪Kiel, Germany
Rhoen Klinikum Meiningen, Gynaekologie und Geburtshilfe
🇩🇪Meiningen, Germany
National University Hospital/Department of Heamatology-Oncology
🇸🇬Singapore, Singapore
Taichung Veterans General Hospital, Department of Surgery
🇨🇳Taichung, Taiwan
Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of
Centro Oncologico Md Anderson International España
🇪🇸Madrid, Spain
Cancer Care Clinic
🇵ðŸ‡Quezon City, Metro Manila, Philippines
National Cancer Center/Department of Medical Oncology
🇸🇬Singapore, Singapore
Changhua Christian Hospital
🇨🇳Changhua, Taiwan
Chi Mei Medical Center, Liouying
🇨🇳Liouying Township, Tainan,, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Chang Gung Medical Foundation, Linkou Branch
🇨🇳Kuei-Shan, Taoyuan, Taiwan
Fundacion Hospital Alcorcon
🇪🇸Alcorcon, Madrid, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
National Taiwan University Hospital/Department of Oncology
🇨🇳Taipei, Taiwan
Management Offices, 4th Floor, Thomas Guy House
🇬🇧London, United Kingdom
Deparment of Cardiology
🇬🇧Glasgow, United Kingdom
St James' Institute of Oncology
🇬🇧Leeds, United Kingdom
Department of Medical Oncology
🇬🇧Manchester, United Kingdom
Dainton Building
🇬🇧Leeds, United Kingdom
Centre Jean Perrin
🇫🇷Clermont Ferrand, France
Polyclinique du Bois
🇫🇷Lille, France
Centre Oscar Lambret
🇫🇷Lille, France
Centre Leon Berard
🇫🇷Lyon, France
Clinique Hartmann
🇫🇷Neuilly Sur Seine, France
Centre Eugene Marquis
🇫🇷Rennes Cedex, France
Hopital Saint-Antoine
🇫🇷Paris, France
Division of Surgery and Oncology
🇬🇧Liverpool, Merseyside, United Kingdom
Royal Marsden Hospital
🇬🇧London, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Hospital São Lucas da PUCRS
🇧🇷Porto Alegre, RS, Brazil
National Cancer Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital / Department of Internal Medecine
🇰🇷Seoul, Republic Of Korea, Korea, Republic of
Universitaetsklinikum Schleswig-Holstein, Campus Luebeck
🇩🇪Luebeck, Germany
Universitaetsklinikum Giessen und Marburg, Standort Marburg
🇩🇪Marburg, Germany
Siteman Cancer Center
🇺🇸Saint Peters, Missouri, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
The Strelitz Diabetes Institute of Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
Hospital Nossa Senhora da Conceicao
🇧🇷Porto Alegre, RS, Brazil
Hopital Saint-Andre
🇫🇷Bordeaux Cedex, France
Queen Mary Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Frauenklinik und Poliklinik, Klinikum rechts der Isar, Technische Universitaet Muenchen
🇩🇪Muenchen, Germany
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Asan Medical Center, Division of Oncology, Department of Internal Medicine
🇰🇷Seoul, Republic Of Korea, Korea, Republic of
Yeungnam University Medical Center/Department of Internal medicine
🇰🇷Daegu, Korea, Republic of
Servicio de Oncologia
🇪🇸Barcelona, Spain
Complexo Hospitalario Universitario A Coruña
🇪🇸La Coruña, Spain
Chung-Ho Memorial Hospital, Kaohsiung Medical University/Department of Surgery
🇨🇳Kaohsiung, Taiwan
The Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
Cardiology Department, Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
Queen Elizabeth Hospital, Department of Clinical Oncology
ðŸ‡ðŸ‡°Kowloon, Hong Kong
Tuen Mun Hospital, Department of Clinical Oncology
ðŸ‡ðŸ‡°Tuen Mun, New Territories, Hong Kong
UNIMED Medical Institute
ðŸ‡ðŸ‡°Wan Chai,, Hong Kong
Department of Clinical Oncology, Tuen Mun Hospital
ðŸ‡ðŸ‡°Tuen Mun, New Territories, Hong Kong