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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-006538-16 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sunitinib | Drug | sunitinib |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University, Winship Cancer Institute | Atlanta | Georgia | 30322 | United States | ||
| Investigational Drug Service |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants receiving sunitinib in previous studies began treatment in this study with the last dose they were taking in the parent or extension study. Participants were to continue to access sunitinib on this protocol as long as there was evidence of disease control and/or clinical benefit in the judgment of the Investigator.
In this open-label extension study, access to sunitinib was provided to participants who had participated in a previous parent study and who had been judged by the Investigator to have likely clinical benefit from continuing sunitinib dosing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sunitinib | Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| From the first day of treatment in parent study until last day of treatment in A6181114 study. |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| The Emory Clinic | Atlanta | Georgia | 30322 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Siteman Cancer Center | City of Saint Peters | Missouri | 63376 | United States |
| Siteman Cancer Center-West County | Creve Coeur | Missouri | 63141 | United States |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine, Siteman Cancer Center | St Louis | Missouri | 63110 | United States |
| Comprehensive Cancer Center of Nevada | Las Vegas | Nevada | 89128 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97213-2982 | United States |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97225 | United States |
| US Oncology Research and Clinical Pharmacy (Drug Shipment Only) | Fort Worth | Texas | 76177 | United States |
| The Strelitz Diabetes Institute of Eastern Virginia Medical School | Norfolk | Virginia | 23510 | United States |
| Instituto Oncologico de Cordoba | Nueva Cordoba | Nueva Cordoba | X5006HBF | Argentina |
| Clinica Viedma | Viedma | Río Negro Province | 8500 | Argentina |
| Centro Oncológico Rosario | Rosario | Santa Fe Province | S2000KZE | Argentina |
| Centro Medico San Roque | San Miguel de Tucumán | T4000IAK | Argentina |
| Royal Brisbane & Women's Hospital | Herston | Queensland | 4029 | Australia |
| Royal Adelaide Hospital, Department of Medical Oncology | Adelaide | South Australia | 5000 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Mount Medical Centre | Perth | Western Australia | 6000 | Australia |
| Hopital Erasme / Gastroenterologie | Brussels | 1070 | Belgium |
| Cliniques Universitaires Saint Luc / Gastroentérologie | Brussels | 1200 | Belgium |
| Cliniques Universitaires Saint-Luc, Oncologie | Brussels | 1200 | Belgium |
| UZ Gasthuisberg, Department Internal Medicine - Gastroenterology - Gastro-intestinal Oncology | Leuven | B-3000 | Belgium |
| Centre Hospitalier Universitaire de Liege | Liège | 4000 | Belgium |
| Algemeen Ziekenhuis Nikolaas | Sint-Niklaas | 9100 | Belgium |
| AZ Sint-Augustinus, Oncologisch Centrum | Wilrijk | 2610 | Belgium |
| Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital Nossa Senhora da Conceicao | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Centro de Oncologia do Instituto de Radiologia | São Paulo | São Paulo | 01246-000 | Brazil |
| Sociedade Beneficente de Senhoras Hospital Sirio Libanes | São Paulo | São Paulo | 01308-050 | Brazil |
| BC Cancer Agency - Vancouver Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| QEII Health Sciences Centre - Nova Scotia Cancer Centre | Halifax | Nova Scotia | B3H 1V7 | Canada |
| QEII Health Sciences Centre - Victoria General Site | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| QEII Health Sciences Centre - Halifax Infirmary Site | Halifax | Nova Scotia | B3H 3A7 | Canada |
| London Regional Cancer Program | London | Ontario | N6A 4L6 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| CHUM, Hopital Saint-Luc | Montreal | Quebec | H2X 3J4 | Canada |
| Royal Victoria Hospital | Montreal | Quebec | H3A 1A1 | Canada |
| Fundacion Centro de Investigacion Clinica CIC | Medellín | Anquioquia | Colombia |
| Hospital Universitario San Vicente de Paul | Medellín | Antioquia | 0 | Colombia |
| Clinica Astorga | Medellín | Antioquia | Colombia |
| Centre Antoine Lacassagne | Nice | Cedex 02 | 06189 | France |
| Hopital Beaujon | Clichy | Cedex | 92118 | France |
| Groupe Hospitalier Cochin, Cancer Quest AP-HP | Paris | Cedex | 75679 | France |
| CHU-Hôpital Jean Minjoz | Besançon | 25030 | France |
| Hopital Saint-Andre | Bordeaux | 33075 | France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| Polyclinique du Bois | Lille | 59000 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Centre Leon Berard | Lyon | 69008 | France |
| Hopital Edouard Herriot | Lyon | 69437 | France |
| Chu La Timone | Marseille | 13385 | France |
| Clinique Hartmann | Neuilly-sur-Seine | 92200 | France |
| Hopital Saint-Antoine | Paris | 75012 | France |
| Centre Eugene Marquis | Rennes | 35042 | France |
| Klinik fuer Innere Medizin, Gastroenterologie, Onkologie, Endokrinologie | Bad Berka | 99437 | Germany |
| Universitaetsklinikum Charité, Campus Virchow Klinikum | Berlin | 13353 | Germany |
| eps - early phase GmbH | Jena | 07743 | Germany |
| Frauenaerzte Pruener Gang | Kiel | 24103 | Germany |
| Klinik fuer Frauenheilkunde und Geburtshilfe, Universitaetsklinikum Schleswig-Holstein | Lübeck | 23538 | Germany |
| Universitaetsklinikum Schleswig-Holstein, Campus Luebeck | Lübeck | 23538 | Germany |
| Universitaetsklinikum Giessen und Marburg, Standort Marburg | Marburg | 35043 | Germany |
| Rhoen Klinikum Meiningen, Gynaekologie und Geburtshilfe | Meiningen | 98617 | Germany |
| Frauenklinik und Poliklinik, Klinikum rechts der Isar, Technische Universitaet Muenchen | München | 81675 | Germany |
| Department of Clinical Oncology, Tuen Mun Hospital | Tuenmen | New Territories | 0 | Hong Kong |
| Queen Mary Hospital | Hong Kong | 150001 | Hong Kong |
| Division of Haematology/Oncology, Department of Medicine, Queen Mary Hospital, | Hong Kong | Hong Kong |
| Queen Elizabeth Hospital, Department of Clinical Oncology | Kowloon | Hong Kong |
| Tuen Mun Hospital, Department of Clinical Oncology | Tuen Mun, New Territories | Hong Kong |
| UNIMED Medical Institute | Wan Chai | Hong Kong |
| Hospital Universitario Dr. Jose Eleuterio Gonzalez Centro Universitario contra el cancer | Monterrey | Nuevo León | 64460 | Mexico |
| Hospital Christus Muguerza del Parque | Chihuahua City | 31000 | Mexico |
| Cancer Care Clinic | Quezon City, Metro Manila | 1100 | Philippines |
| National University Hospital/Department of Heamatology-Oncology | Singapore | 119074 | Singapore |
| National Cancer Center/Department of Medical Oncology | Singapore | 169610 | Singapore |
| National Cancer Center | Goyang-si | Gyeonggi-do | 410-769 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| Seoul National University Hospital / Department of Internal Medecine | Seoul | Republic of Korea | 110-744 | South Korea |
| Asan Medical Center, Division of Oncology, Department of Internal Medicine | Seoul | Republic of Korea | 138-736 | South Korea |
| Yeungnam University Medical Center/Department of Internal medicine | Daegu | 705-717 | South Korea |
| Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine | Seoul | 120-752 | South Korea |
| Corporacio Sanitaria Parc Tauli | Sabadell | Barcelona | 08208 | Spain |
| Fundacion Hospital Alcorcon | Alcorcón | Madrid | 28922 | Spain |
| Complexo Hospitalario Universitario A Coruña | A Coruña | 15006 | Spain |
| Servicio de Oncologia | Barcelona | 08035 | Spain |
| Centro Oncologico Md Anderson International España | Madrid | 28033 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Chi Mei Medical Center, Liouying | Liouying Township, Tainan, | Taiwan | 736 | Taiwan |
| Chi-Mei Medical Center | YungKang City, Tainan | Taiwan | 710 | Taiwan |
| Chang Gung Medical Foundation, Linkou Branch | Guishanli | Taoyuan | 333 | Taiwan |
| Changhua Christian Hospital | Changhua | 500 | Taiwan |
| Chung-Ho Memorial Hospital, Kaohsiung Medical University/Department of Surgery | Kaohsiung City | 807 | Taiwan |
| Taichung Veterans General Hospital, Department of Surgery | Taichung | 407 | Taiwan |
| National Taiwan University Hospital/Department of Oncology | Taipei | 100 | Taiwan |
| Koo Foundation Sun Yat-Sen Cancer Center, Div. of Hematology/Oncology | Taipei | 112 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| Division of Surgery and Oncology | Liverpool | Merseyside | L69 3GA | United Kingdom |
| Deparment of Cardiology | Glasgow | G116NT | United Kingdom |
| The Beatson West of Scotland Cancer Centre | Glasgow | G12 0YH | United Kingdom |
| Dainton Building | Leeds | LS16 6QB | United Kingdom |
| St James' Institute of Oncology | Leeds | LS9 7TF | United Kingdom |
| Management Offices, 4th Floor, Thomas Guy House | London | SE1 9RT | United Kingdom |
| Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| Department of Medical Oncology | Manchester | M20 4BX | United Kingdom |
| Cardiology Department, Wythenshawe Hospital | Manchester | M23 9LT | United Kingdom |
| Nottingham City Hospital | Nottingham | NG5 1PB | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib | Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study. | Posted | Number | participants | 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. | The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study. | Posted | Number | participants | From first day of treatment on the current study up to 28 days post the last dose of study treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study. | Posted | Mean | Standard Deviation | Weeks | From the first day of treatment in parent study until last day of treatment in A6181114 study. |
|
From first day of treatment on the current study up to 28 days post the last dose of study treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sunitinib | Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily. | 90 | 223 | 219 | 223 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Mallory-weiss syndrome | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA v17.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.0 | Non-systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.0 | Non-systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.0 | Non-systematic Assessment |
| |
| Lymphangiosis carcinomatosa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.0 | Non-systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v17.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Scrotal erythema | Reproductive system and breast disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA v17.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Abdominal distention | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v17.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Yellow skin | Skin and subcutaneous tissue disorders | MedDRA v17.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v17.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D013964 | Thyroid Neoplasms |
| D046152 | Gastrointestinal Stromal Tumors |
| D006528 | Carcinoma, Hepatocellular |
| D013005 | Somatostatinoma |
| D007516 | Adenoma, Islet Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D018273 | Carcinoma, Islet Cell |
| D010190 | Pancreatic Neoplasms |
| D010182 | Pancreatic Diseases |
| D000236 | Adenoma |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Participants with grade 5 AEs |
|
| Participants discontinued due to AEs |
|
| Participants with dose reduction due to AEs |
|
| Temporary discontinuations due to AEs |
|
|
| OG004 | Sunitinib 5 | Parent Study: A6181110 |
| OG005 | Sunitinib 6 | Parent Study: A6181111 |
| OG006 | Sunitinib 7 | Parent Study: A6181112 |
| OG007 | Sunitinib 8 | Parent Study: A6181113 |
| OG008 | Sunitinib 9 | Parent Study: A6181120 |
| OG009 | Sunitinib 10 | Parent Study: A6181126 |
| OG010 | Sunitinib 11 | Parent Study: A6181170 |
|
|