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

NCT00428220 | Completed Results

• 2 other identifiers: A61811142006-006538-16
• Study Type: interventional
• Target: 223
• Locations: 17 countries
• Sites: 113

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.

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities)

  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.

  From first day of treatment on the current study up to 28 days post the last dose of study treatment

• Number of Participants With Treatment-emergent AEs (Treatment-Related)

  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.

  From first day of treatment on the current study up to 28 days post the last dose of study treatment

Other Outcomes (1)

• Summary of Duration of Clinical Benefit

  From the first day of treatment in parent study until last day of treatment in A6181114 study.

Study Arms (1)

A

EXPERIMENTAL

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.

Drug: sunitinib

Interventions

sunitinib DRUG

sunitinib

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (113)

Emory University, Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Investigational Drug Service

Atlanta, Georgia, 30322, United States

Location

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Siteman Cancer Center

City of Saint Peters, Missouri, 63376, United States

Location

Siteman Cancer Center-West County

Creve Coeur, Missouri, 63141, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine, Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Comprehensive Cancer Center of Nevada

Las Vegas, Nevada, 89128, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Northwest Cancer Specialists, P.C.

Portland, Oregon, 97213-2982, United States

Location

Northwest Cancer Specialists, P.C.

Portland, Oregon, 97225, United States

Location

US Oncology Research and Clinical Pharmacy (Drug Shipment Only)

Fort Worth, Texas, 76177, United States

Location

The Strelitz Diabetes Institute of Eastern Virginia Medical School

Norfolk, Virginia, 23510, United States

Location

Instituto Oncologico de Cordoba

Nueva Cordoba, Nueva Cordoba, X5006HBF, Argentina

Location

Clinica Viedma

Viedma, Río Negro Province, 8500, Argentina

Location

Centro Oncológico Rosario

Rosario, Santa Fe Province, S2000KZE, Argentina

Location

Centro Medico San Roque

San Miguel de Tucumán, T4000IAK, Argentina

Location

Royal Brisbane & Women's Hospital

Herston, Queensland, 4029, Australia

Location

Royal Adelaide Hospital, Department of Medical Oncology

Adelaide, South Australia, 5000, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Mount Medical Centre

Perth, Western Australia, 6000, Australia

Location

Hopital Erasme / Gastroenterologie

Brussels, 1070, Belgium

Location

Cliniques Universitaires Saint Luc / Gastroentérologie

Brussels, 1200, Belgium

Location

Cliniques Universitaires Saint-Luc, Oncologie

Brussels, 1200, Belgium

Location

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

Leuven, B-3000, Belgium

Location

Centre Hospitalier Universitaire de Liege

Liège, 4000, Belgium

Location

Algemeen Ziekenhuis Nikolaas

Sint-Niklaas, 9100, Belgium

Location

AZ Sint-Augustinus, Oncologisch Centrum

Wilrijk, 2610, Belgium

Location

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Centro de Oncologia do Instituto de Radiologia

São Paulo, São Paulo, 01246-000, Brazil

Location

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

São Paulo, São Paulo, 01308-050, Brazil

Location

BC Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

QEII Health Sciences Centre - Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

QEII Health Sciences Centre - Victoria General Site

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

QEII Health Sciences Centre - Halifax Infirmary Site

Halifax, Nova Scotia, B3H 3A7, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM, Hopital Saint-Luc

Montreal, Quebec, H2X 3J4, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Fundacion Centro de Investigacion Clinica CIC

Medellín, Anquioquia, Colombia

Location

Hospital Universitario San Vicente de Paul

Medellín, Antioquia, 0, Colombia

Location

Clinica Astorga

Medellín, Antioquia, Colombia

Location

Centre Antoine Lacassagne

Nice, Cedex 02, 06189, France

Location

Hopital Beaujon

Clichy, Cedex, 92118, France

Location

Groupe Hospitalier Cochin, Cancer Quest AP-HP

Paris, Cedex, 75679, France

Location

CHU-Hôpital Jean Minjoz

Besançon, 25030, France

Location

Hopital Saint-Andre

Bordeaux, 33075, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Polyclinique du Bois

Lille, 59000, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

Chu La Timone

Marseille, 13385, France

Location

Clinique Hartmann

Neuilly-sur-Seine, 92200, France

Location

Hopital Saint-Antoine

Paris, 75012, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Klinik fuer Innere Medizin, Gastroenterologie, Onkologie, Endokrinologie

Bad Berka, 99437, Germany

Location

Universitaetsklinikum Charité, Campus Virchow Klinikum

Berlin, 13353, Germany

Location

eps - early phase GmbH

Jena, 07743, Germany

Location

Frauenaerzte Pruener Gang

Kiel, 24103, Germany

Location

Klinik fuer Frauenheilkunde und Geburtshilfe, Universitaetsklinikum Schleswig-Holstein

Lübeck, 23538, Germany

Location

Universitaetsklinikum Schleswig-Holstein, Campus Luebeck

Lübeck, 23538, Germany

Location

Universitaetsklinikum Giessen und Marburg, Standort Marburg

Marburg, 35043, Germany

Location

Rhoen Klinikum Meiningen, Gynaekologie und Geburtshilfe

Meiningen, 98617, Germany

Location

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

München, 81675, Germany

Location

Department of Clinical Oncology, Tuen Mun Hospital

Tuenmen, New Territories, 0, Hong Kong

Location

Queen Mary Hospital

Hong Kong, 150001, Hong Kong

Location

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

Hong Kong, Hong Kong

Location

Queen Elizabeth Hospital, Department of Clinical Oncology

Kowloon, Hong Kong

Location

Tuen Mun Hospital, Department of Clinical Oncology

Tuen Mun, New Territories, Hong Kong

Location

UNIMED Medical Institute

Wan Chai, Hong Kong

Location

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

Monterrey, Nuevo León, 64460, Mexico

Location

Hospital Christus Muguerza del Parque

Chihuahua City, 31000, Mexico

Location

Cancer Care Clinic

Quezon City, Metro Manila, 1100, Philippines

Location

National University Hospital/Department of Heamatology-Oncology

Singapore, 119074, Singapore

Location

National Cancer Center/Department of Medical Oncology

Singapore, 169610, Singapore

Location

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Seoul National University Hospital / Department of Internal Medecine

Seoul, Republic of Korea, 110-744, South Korea

Location

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

Seoul, Republic of Korea, 138-736, South Korea

Location

Yeungnam University Medical Center/Department of Internal medicine

Daegu, 705-717, South Korea

Location

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

Seoul, 120-752, South Korea

Location

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Fundacion Hospital Alcorcon

Alcorcón, Madrid, 28922, Spain

Location

Complexo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Servicio de Oncologia

Barcelona, 08035, Spain

Location

Centro Oncologico Md Anderson International España

Madrid, 28033, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Chi Mei Medical Center, Liouying

Liouying Township, Tainan,, Taiwan, 736, Taiwan

Location

Chi-Mei Medical Center

YungKang City, Tainan, Taiwan, 710, Taiwan

Location

Chang Gung Medical Foundation, Linkou Branch

Guishanli, Taoyuan, 333, Taiwan

Location

Changhua Christian Hospital

Changhua, 500, Taiwan

Location

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

Kaohsiung City, 807, Taiwan

Location

Taichung Veterans General Hospital, Department of Surgery

Taichung, 407, Taiwan

Location

National Taiwan University Hospital/Department of Oncology

Taipei, 100, Taiwan

Location

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

Taipei, 112, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Division of Surgery and Oncology

Liverpool, Merseyside, L69 3GA, United Kingdom

Location

Deparment of Cardiology

Glasgow, G116NT, United Kingdom

Location

The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YH, United Kingdom

Location

Dainton Building

Leeds, LS16 6QB, United Kingdom

Location

St James' Institute of Oncology

Leeds, LS9 7TF, United Kingdom

Location

Management Offices, 4th Floor, Thomas Guy House

London, SE1 9RT, United Kingdom

Location

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

Department of Medical Oncology

Manchester, M20 4BX, United Kingdom

Location

Cardiology Department, Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms; Gastrointestinal Stromal Tumors; Carcinoma, Hepatocellular; Somatostatinoma; Adenoma, Islet Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Liver Neoplasms; Liver Diseases; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Carcinoma, Islet Cell; Pancreatic Neoplasms; Pancreatic Diseases; Adenoma

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2007
• First Posted: January 29, 2007
• Study Start: July 1, 2007
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 27, 2019
• Results First Posted: November 6, 2015

Record last verified: 2019-06

Locations

BR (4); BE (7); CA (8); CO (3); HK (6); GB (10); TW (9); KR (6); ES (8); DE (9); AR (4); AU (5); PH (1); ME (2); US (15); SG (2); FR (14)