Metastatic Breast CancerNCT00428220
A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study.
A study testing sunitinib in people with Metastatic Breast Cancer and Advanced Breast Cancer, run by Pfizer at 113 sites in 17 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Advanced Breast Cancer, Metastatic Castration Resistant Prostate Cancer
- What is being tested?
- sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 113 sitesin 17 countries
- Study dates
- Jul 2007to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- See inclusion criteria
Trial locations and contacts
113 sites in 17 countries.
113 sites in 17 countries
United States15 sites
Emory University, Winship Cancer Institute
Atlanta, Georgia, 30322
Investigational Drug Service
Atlanta, Georgia, 30322
The Emory Clinic
Atlanta, Georgia, 30322
Siteman Cancer Center
City of Saint Peters, Missouri, 63376
Siteman Cancer Center-West County
Creve Coeur, Missouri, 63141
US Oncology Research and Clinical Pharmacy (Drug Shipment Only)
Fort Worth, Texas, 76177
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, 89128
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Loyola University Medical Center
Maywood, Illinois, 60153
The Strelitz Diabetes Institute of Eastern Virginia Medical School
Norfolk, Virginia, 23510
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97213-2982
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97225
Barnes Jewish Hospital
St Louis, Missouri, 63110
Washington University School of Medicine, Siteman Cancer Center
St Louis, Missouri, 63110
France14 sites
CHU-Hôpital Jean Minjoz
Besançon, 25030
Hopital Saint-Andre
Bordeaux, 33075
Centre Jean Perrin
Clermont-Ferrand, 63011
Hopital Beaujon
Clichy, Cedex, 92118
Polyclinique du Bois
Lille, 59000
Centre Oscar Lambret
Lille, 59020
Centre Leon Berard
Lyon, 69008
Hopital Edouard Herriot
Lyon, 69437
Chu La Timone
Marseille, 13385
Clinique Hartmann
Neuilly-sur-Seine, 92200
Centre Antoine Lacassagne
Nice, Cedex 02, 06189
Groupe Hospitalier Cochin, Cancer Quest AP-HP
Paris, Cedex, 75679
Hopital Saint-Antoine
Paris, 75012
Centre Eugene Marquis
Rennes, 35042
United Kingdom10 sites
Deparment of Cardiology
Glasgow, G116NT
The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YH
Dainton Building
Leeds, LS16 6QB
St James' Institute of Oncology
Leeds, LS9 7TF
Division of Surgery and Oncology
Liverpool, Merseyside, L69 3GA
Management Offices, 4th Floor, Thomas Guy House
London, SE1 9RT
Royal Marsden Hospital
London, SW3 6JJ
Department of Medical Oncology
Manchester, M20 4BX
Cardiology Department, Wythenshawe Hospital
Manchester, M23 9LT
Nottingham City Hospital
Nottingham, NG5 1PB
Germany9 sites
Klinik fuer Innere Medizin, Gastroenterologie, Onkologie, Endokrinologie
Bad Berka, 99437
Universitaetsklinikum Charité, Campus Virchow Klinikum
Berlin, 13353
eps - early phase GmbH
Jena, 07743
Frauenaerzte Pruener Gang
Kiel, 24103
Klinik fuer Frauenheilkunde und Geburtshilfe, Universitaetsklinikum Schleswig-Holstein
Lübeck, 23538
Universitaetsklinikum Schleswig-Holstein, Campus Luebeck
Lübeck, 23538
Universitaetsklinikum Giessen und Marburg, Standort Marburg
Marburg, 35043
Rhoen Klinikum Meiningen, Gynaekologie und Geburtshilfe
Meiningen, 98617
Frauenklinik und Poliklinik, Klinikum rechts der Isar, Technische Universitaet Muenchen
München, 81675
Taiwan9 sites
Changhua Christian Hospital
Changhua, 500
Chang Gung Medical Foundation, Linkou Branch
Guishanli, Taoyuan, 333
Chung-Ho Memorial Hospital, Kaohsiung Medical University/Department of Surgery
Kaohsiung City, 807
Chi Mei Medical Center, Liouying
Liouying Township, Tainan,, Taiwan, 736
Taichung Veterans General Hospital, Department of Surgery
Taichung, 407
National Taiwan University Hospital/Department of Oncology
Taipei, 100
Koo Foundation Sun Yat-Sen Cancer Center, Div. of Hematology/Oncology
Taipei, 112
Taipei Veterans General Hospital
Taipei, 112
Chi-Mei Medical Center
YungKang City, Tainan, Taiwan, 710
Canada8 sites
QEII Health Sciences Centre - Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
QEII Health Sciences Centre - Victoria General Site
Halifax, Nova Scotia, B3H 2Y9
QEII Health Sciences Centre - Halifax Infirmary Site
Halifax, Nova Scotia, B3H 3A7
London Regional Cancer Program
London, Ontario, N6A 4L6
CHUM, Hopital Saint-Luc
Montreal, Quebec, H2X 3J4
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
Spain8 sites
Complexo Hospitalario Universitario A Coruña
A Coruña, 15006
Fundacion Hospital Alcorcon
Alcorcón, Madrid, 28922
Servicio de Oncologia
Barcelona, 08035
Centro Oncologico Md Anderson International España
Madrid, 28033
Hospital Clinico San Carlos
Madrid, 28040
Hospital 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 08208
Belgium7 sites
Hopital Erasme / Gastroenterologie
Brussels, 1070
Cliniques Universitaires Saint Luc / Gastroentérologie
Brussels, 1200
Cliniques Universitaires Saint-Luc, Oncologie
Brussels, 1200
UZ Gasthuisberg, Department Internal Medicine - Gastroenterology - Gastro-intestinal Oncology
Leuven, B-3000
Centre Hospitalier Universitaire de Liege
Liège, 4000
Algemeen Ziekenhuis Nikolaas
Sint-Niklaas, 9100
AZ Sint-Augustinus, Oncologisch Centrum
Wilrijk, 2610
Hong Kong6 sites
Queen Mary Hospital
Hong Kong, 150001
Division of Haematology/Oncology, Department of Medicine, Queen Mary Hospital,
Hong Kong
Queen Elizabeth Hospital, Department of Clinical Oncology
Kowloon
Tuen Mun Hospital, Department of Clinical Oncology
Tuen Mun, New Territories
Department of Clinical Oncology, Tuen Mun Hospital
Tuenmen, New Territories, 0
UNIMED Medical Institute
Wan Chai
South Korea6 sites
Yeungnam University Medical Center/Department of Internal medicine
Daegu, 705-717
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Seoul National University Hospital / Department of Internal Medecine
Seoul, Republic of Korea, 110-744
Asan Medical Center, Division of Oncology, Department of Internal Medicine
Seoul, Republic of Korea, 138-736
Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine
Seoul, 120-752
Australia5 sites
Royal Adelaide Hospital, Department of Medical Oncology
Adelaide, South Australia, 5000
Austin Health
Heidelberg, Victoria, 3084
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029
Royal Melbourne Hospital
Parkville, Victoria, 3050
Mount Medical Centre
Perth, Western Australia, 6000
Argentina4 sites
Instituto Oncologico de Cordoba
Nueva Cordoba, Nueva Cordoba, X5006HBF
Centro Oncológico Rosario
Rosario, Santa Fe Province, S2000KZE
Centro Medico San Roque
San Miguel de Tucumán, T4000IAK
Clinica Viedma
Viedma, Río Negro Province, 8500
Brazil4 sites
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 91350-200
Centro de Oncologia do Instituto de Radiologia
São Paulo, São Paulo, 01246-000
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, São Paulo, 01308-050
Colombia3 sites
Fundacion Centro de Investigacion Clinica CIC
Medellín, Anquioquia
Hospital Universitario San Vicente de Paul
Medellín, Antioquia, 0
Clinica Astorga
Medellín, Antioquia
Mexico2 sites
Hospital Christus Muguerza del Parque
Chihuahua City, 31000
Hospital Universitario Dr. Jose Eleuterio Gonzalez Centro Universitario contra el cancer
Monterrey, Nuevo León, 64460
Singapore2 sites
National University Hospital/Department of Heamatology-Oncology
Singapore, 119074
National Cancer Center/Department of Medical Oncology
Singapore, 169610
About this 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
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
- Being tested
- sunitinib
- Keywords
- Potentially other tumor types in the future
- Medical subject headings
- Breast Neoplasms, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Thyroid Neoplasms, Gastrointestinal Stromal Tumors, Carcinoma, Hepatocellular, Somatostatinoma, Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinibDrug
sunitinib
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From first day of treatment on the current study up to 28 days post the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startJul 2007
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428220
- Sponsor's protocol ID
- A6181114
- Other IDs
- 2006-006538-16
- Status last verified
- Jun 2019
- First submitted
- 26 Jan 2007
- Last updated
- 27 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00428220
- Acronym / sponsor ID
- A6181114
- Conditions
- Metastatic Breast Cancer, Advanced Breast Cancer, Metastatic Castration Resistant Prostate Cancer, Metastatic Renal Cell Cancer, Non-Small Cell Lung Cancer, Thyroid Cancer
- Keywords
- Potentially other tumor types in the future
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 29 Jan 2007 (estimated)
- Results
- Posted 6 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: sunitinibSunitinib 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- See inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sunitinibsunitinib | Drug | A |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities)
Time frame: 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 AEs (Treatment-Related)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
113 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sunitinib in people with Metastatic Breast Cancer and Advanced Breast Cancer, run by Pfizer at 113 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 113 sites in United States, France, United Kingdom, Germany, Taiwan and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) (time frame: From first day of treatment on the current study up to 28 days post the last dose of study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.