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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00428220
• Other study ID #: A6181114
• Secondary ID: 2006-006538-16
• Status: Completed
• Phase: N/A
• Start date: July 2007
• Est. completion date: September 2014

Study information

• Verified date: June 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• sunitinib
sunitinib

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Summary of Duration of Clinical Benefit	Duration of clinical benefit is defined as the length of time participants remain on sunitinib from the first day of treatment on the parent protocol until the end of sunitinib treatment in this study (A6181114). For participants who were on placebo or a comparator drug in the parent study, duration of clinical benefit is defined as the length of time participants are on sunitinib in this study.	From the first day of treatment in parent study until last day of treatment in A6181114 study.
Primary	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
Primary	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

External Links

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