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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00428220
• Collaborator: (none)
• Enrollment: 223
• Locations: 113
• Arm: 1
• Duration (Months): 86
• Patients Per Site: 2
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: sunitinib	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 223 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Experimental: A 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; sunitinib

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Other Outcome Measures

1. Summary of Duration of Clinical Benefit [From the first day of treatment in parent study until last day of treatment in A6181114 study.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University, Winship Cancer Institute	Atlanta	Georgia	United States	30322
2	Investigational Drug Service	Atlanta	Georgia	United States	30322
3	The Emory Clinic	Atlanta	Georgia	United States	30322
4	Loyola University Medical Center	Maywood	Illinois	United States	60153
5	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
6	Siteman Cancer Center-West County	Creve Coeur	Missouri	United States	63141
7	Barnes Jewish Hospital	Saint Louis	Missouri	United States	63110
8	Washington University School of Medicine, Siteman Cancer Center	Saint Louis	Missouri	United States	63110
9	Siteman Cancer Center	Saint Peters	Missouri	United States	63376
10	Comprehensive Cancer Center of Nevada	Las Vegas	Nevada	United States	89128
11	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89169
12	Northwest Cancer Specialists, P.C.	Portland	Oregon	United States	97213-2982
13	Northwest Cancer Specialists, P.C.	Portland	Oregon	United States	97225
14	US Oncology Research and Clinical Pharmacy (Drug Shipment Only)	Fort Worth	Texas	United States	76177
15	The Strelitz Diabetes Institute of Eastern Virginia Medical School	Norfolk	Virginia	United States	23510
16	Clinica Viedma	Viedma	Rio Negro	Argentina	8500
17	Centro Oncológico Rosario	Rosario	Santa Fé	Argentina	S2000KZE
18	Instituto Oncologico de Cordoba	Nueva Cordoba		Argentina	X5006HBF
19	Centro Medico San Roque	San Miguel de Tucuman		Argentina	T4000IAK
20	Royal Brisbane & Women's Hospital	Herston	Queensland	Australia	4029
21	Royal Adelaide Hospital, Department of Medical Oncology	Adelaide	South Australia	Australia	5000
22	Austin Health	Heidelberg	Victoria	Australia	3084
23	Royal Melbourne Hospital	Parkville	Victoria	Australia	3050
24	Mount Medical Centre	Perth	Western Australia	Australia	6000
25	Hopital Erasme / Gastroenterologie	Bruxelles		Belgium	1070
26	Cliniques Universitaires Saint Luc / Gastroentérologie	Bruxelles		Belgium	1200
27	Cliniques Universitaires Saint-Luc, Oncologie	Bruxelles		Belgium	1200
28	UZ Gasthuisberg, Department Internal Medicine - Gastroenterology - Gastro-intestinal Oncology	Leuven		Belgium	B-3000
29	Centre Hospitalier Universitaire de Liege	Liege		Belgium	4000
30	Algemeen Ziekenhuis Nikolaas	Sint-Niklaas		Belgium	9100
31	AZ Sint-Augustinus, Oncologisch Centrum	Wilrijk		Belgium	2610
32	Hospital São Lucas da PUCRS	Porto Alegre	RS	Brazil	90610-000
33	Hospital Nossa Senhora da Conceicao	Porto Alegre	RS	Brazil	91350-200
34	Sociedade Beneficente de Senhoras Hospital Sirio Libanes	Sao Paulo	SP	Brazil	01308-050
35	Centro de Oncologia do Instituto de Radiologia	São Paulo	SP	Brazil	01246-000
36	BC Cancer Agency - Vancouver Centre	Vancouver	British Columbia	Canada	V5Z 4E6
37	QEII Health Sciences Centre - Nova Scotia Cancer Centre	Halifax	Nova Scotia	Canada	B3H 1V7
38	QEII Health Sciences Centre - Victoria General Site	Halifax	Nova Scotia	Canada	B3H 2Y9
39	QEII Health Sciences Centre - Halifax Infirmary Site	Halifax	Nova Scotia	Canada	B3H 3A7
40	London Regional Cancer Program	London	Ontario	Canada	N6A 4L6
41	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
42	CHUM, Hopital Saint-Luc	Montreal	Quebec	Canada	H2X 3J4
43	Royal Victoria Hospital	Montreal	Quebec	Canada	H3A 1A1
44	Fundacion Centro de Investigacion Clinica CIC	Medellin	Anquioquia	Colombia
45	Hospital Universitario San Vicente de Paul	Medellin	Antioquia	Colombia	0
46	Clinica Astorga	Medellin	Antioquia	Colombia
47	Centre Antoine Lacassagne	Nice	Cedex 02	France	06189
48	Hopital Beaujon	Clichy Cedex	Cedex	France	92118
49	Groupe Hospitalier Cochin, Cancer Quest AP-HP	Paris	Cedex	France	75679
50	CHU-Hôpital Jean Minjoz	Besancon		France	25030
51	Hopital Saint-Andre	Bordeaux Cedex		France	33075
52	Centre Jean Perrin	Clermont Ferrand		France	63011
53	Polyclinique du Bois	Lille		France	59000
54	Centre Oscar Lambret	Lille		France	59020
55	Hopital Edouard Herriot	Lyon Cedex 03		France	69437
56	Centre Leon Berard	Lyon		France	69008
57	Chu La Timone	Marseille Cedex 5		France	13385
58	Clinique Hartmann	Neuilly Sur Seine		France	92200
59	Hopital Saint-Antoine	Paris		France	75012
60	Centre Eugene Marquis	Rennes Cedex		France	35042
61	Klinik fuer Innere Medizin, Gastroenterologie, Onkologie, Endokrinologie	Bad Berka		Germany	99437
62	Universitaetsklinikum Charité, Campus Virchow Klinikum	Berlin		Germany	13353
63	eps - early phase GmbH	Jena		Germany	07743
64	Frauenaerzte Pruener Gang	Kiel		Germany	24103
65	Klinik fuer Frauenheilkunde und Geburtshilfe, Universitaetsklinikum Schleswig-Holstein	Luebeck		Germany	23538
66	Universitaetsklinikum Schleswig-Holstein, Campus Luebeck	Luebeck		Germany	23538
67	Universitaetsklinikum Giessen und Marburg, Standort Marburg	Marburg		Germany	35043
68	Rhoen Klinikum Meiningen, Gynaekologie und Geburtshilfe	Meiningen		Germany	98617
69	Frauenklinik und Poliklinik, Klinikum rechts der Isar, Technische Universitaet Muenchen	Muenchen		Germany	81675
70	Department of Clinical Oncology, Tuen Mun Hospital	Tuen Mun	New Territories	Hong Kong	0
71	Queen Mary Hospital	Hong Kong		Hong Kong	150001
72	Division of Haematology/Oncology, Department of Medicine, Queen Mary Hospital,	Hong Kong		Hong Kong
73	Queen Elizabeth Hospital, Department of Clinical Oncology	Kowloon		Hong Kong
74	Tuen Mun Hospital, Department of Clinical Oncology	Tuen Mun, New Territories		Hong Kong
75	UNIMED Medical Institute	Wan Chai,		Hong Kong
76	National Cancer Center	Goyang-si	Gyeonggi-do	Korea, Republic of	410-769
77	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	463-707
78	Seoul National University Hospital / Department of Internal Medecine	Seoul	Republic Of Korea	Korea, Republic of	110-744
79	Asan Medical Center, Division of Oncology, Department of Internal Medicine	Seoul	Republic Of Korea	Korea, Republic of	138-736
80	Yeungnam University Medical Center/Department of Internal medicine	Daegu		Korea, Republic of	705-717
81	Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine	Seoul		Korea, Republic of	120-752
82	Hospital Universitario Dr. Jose Eleuterio Gonzalez Centro Universitario contra el cancer	Monterrey	Nuevo Leon	Mexico	64460
83	Hospital Christus Muguerza del Parque	Chihuahua		Mexico	31000
84	Cancer Care Clinic	Quezon City, Metro Manila		Philippines	1100
85	National University Hospital/Department of Heamatology-Oncology	Singapore		Singapore	119074
86	National Cancer Center/Department of Medical Oncology	Singapore		Singapore	169610
87	Corporacio Sanitaria Parc Tauli	Sabadell	Barcelona	Spain	08208
88	Fundacion Hospital Alcorcon	Alcorcon	Madrid	Spain	28922
89	Servicio de Oncologia	Barcelona		Spain	08035
90	Complexo Hospitalario Universitario A Coruña	La Coruña		Spain	15006
91	Centro Oncologico Md Anderson International España	Madrid		Spain	28033
92	Hospital Clinico San Carlos	Madrid		Spain	28040
93	Hospital 12 de Octubre	Madrid		Spain	28041
94	Hospital Universitario La Paz	Madrid		Spain	28046
95	Chang Gung Medical Foundation, Linkou Branch	Kuei-Shan	Taoyuan	Taiwan	333
96	Changhua Christian Hospital	Changhua		Taiwan	500
97	Chung-Ho Memorial Hospital, Kaohsiung Medical University/Department of Surgery	Kaohsiung		Taiwan	807
98	Chi Mei Medical Center, Liouying	Liouying Township, Tainan,		Taiwan	736
99	Taichung Veterans General Hospital, Department of Surgery	Taichung		Taiwan	407
100	National Taiwan University Hospital/Department of Oncology	Taipei		Taiwan	100
101	Koo Foundation Sun Yat-Sen Cancer Center, Div. of Hematology/Oncology	Taipei		Taiwan	112
102	Taipei Veterans General Hospital	Taipei		Taiwan	112
103	Chi-Mei Medical Center	YungKang City, Tainan		Taiwan	710
104	Division of Surgery and Oncology	Liverpool	Merseyside	United Kingdom	L69 3GA
105	Deparment of Cardiology	Glasgow		United Kingdom	G116NT
106	The Beatson West of Scotland Cancer Centre	Glasgow		United Kingdom	G12 0YH
107	Dainton Building	Leeds		United Kingdom	LS16 6QB
108	St James' Institute of Oncology	Leeds		United Kingdom	LS9 7TF
109	Management Offices, 4th Floor, Thomas Guy House	London		United Kingdom	SE1 9RT
110	Royal Marsden Hospital	London		United Kingdom	SW3 6JJ
111	Department of Medical Oncology	Manchester		United Kingdom	M20 4BX
112	Cardiology Department, Wythenshawe Hospital	Manchester		United Kingdom	M23 9LT
113	Nottingham City Hospital	Nottingham		United Kingdom	NG5 1PB

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00428220
• Other Study ID Numbers: A6181114; 2006-006538-16
• First Posted: Jan 29, 2007
• Last Update Posted: Jun 27, 2019
• Last Verified: Jun 1, 2019

• Keywords provided by Pfizer: Potentially other tumor types in the future
• Additional relevant MeSH terms: Carcinoma; Breast Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neuroendocrine Tumors; Carcinoma, Renal Cell; Gastrointestinal Stromal Tumors; Carcinoma, Islet Cell; Sunitinib

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Sunitinib
Arm/Group Description	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.
Period Title: Overall Study
STARTED	223
COMPLETED	0
NOT COMPLETED	223

Baseline Characteristics

Arm/Group Title	Sunitinib
Arm/Group Description	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.
Overall Participants	223
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.2 (12.5)
Sex: Female, Male (Count of Participants)
Female	130 58.3%
Male	93 41.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities)
Description	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.
Time Frame	From first day of treatment on the current study up to 28 days post the last dose of study treatment

Outcome Measure Data

Analysis Population Description

The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.

Arm/Group Title	Sunitinib
Arm/Group Description	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.
Measure Participants	223
Participants with adverse events (AE)	221 99.1%
Participants with serious adverse events (SAE)	90 40.4%
Participants with grade 3 or 4 AEs	174 78%
Participants with grade 5 AEs	24 10.8%
Participants discontinued due to AEs	67 30%
Participants with dose reduction due to AEs	66 29.6%
Temporary discontinuations due to AEs	146 65.5%

2. Primary Outcome

Title	Number of Participants With Treatment-emergent AEs (Treatment-Related)
Description	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.
Time Frame	From first day of treatment on the current study up to 28 days post the last dose of study treatment

Outcome Measure Data

Analysis Population Description

The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.

Arm/Group Title	Sunitinib
Arm/Group Description	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.
Measure Participants	223
Participants with AE	217 97.3%
Participants with SAE	39 17.5%
Participants with grade 3 or 4 AEs	146 65.5%
Participants with grade 5 AEs	0 0%
Participants discontinued due to AEs	29 13%
Participants with dose reduction due to AEs	64 28.7%
Temporary discontinuations due to AEs	135 60.5%

3. Other Pre-specified Outcome

Title	Summary of Duration of Clinical Benefit
Description	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.
Time Frame	From the first day of treatment in parent study until last day of treatment in A6181114 study.

Outcome Measure Data

Analysis Population Description

The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.

Arm/Group Title	Sunitinib 1	Sunitinib 2	Sunitinib 3	Sunitinib 4	Sunitinib 5	Sunitinib 6	Sunitinib 7	Sunitinib 8	Sunitinib 9	Sunitinib 10	Sunitinib 11
Arm/Group Description	Parent Study: A6181078	Parent Study: A6181087	Parent Study: A6181094	Parent Study: A6181107	Parent Study: A6181110	Parent Study: A6181111	Parent Study: A6181112	Parent Study: A6181113	Parent Study: A6181120	Parent Study: A6181126	Parent Study: A6181170
Measure Participants	3	1	2	69	38	95	8	1	3	1	2
Mean (Standard Deviation) [Weeks]	186.6 (68.2)	76.0 (NA)	157.5 (6.2)	22.1 (25.2)	122.9 (73.4)	76.6 (69.0)	71.6 (26.2)	198.9 (NA)	142.2 (23.6)	183.6 (NA)	227.5 (57.9)

Adverse Events

Time Frame	From first day of treatment on the current study up to 28 days post the last dose of study treatment
Adverse Event Reporting Description	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.
Arm/Group Title	Sunitinib
Arm/Group Description	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.
All Cause Mortality
	Sunitinib
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Sunitinib
	Affected / at Risk (%)	# Events
Total	90/223 (40.4%)
Blood and lymphatic system disorders
Anaemia	5/223 (2.2%)
Neutropenia	1/223 (0.4%)
Thrombocytopenia	1/223 (0.4%)
Cardiac disorders
Acute coronary syndrome	1/223 (0.4%)
Acute myocardial infarction	1/223 (0.4%)
Myocardial infarction	1/223 (0.4%)
Gastrointestinal disorders
Abdominal adhesions	1/223 (0.4%)
Abdominal pain	8/223 (3.6%)
Abdominal pain upper	2/223 (0.9%)
Ascites	2/223 (0.9%)
Diarrhoea	6/223 (2.7%)
Duodenitis	1/223 (0.4%)
Gastritis	1/223 (0.4%)
Gastrointestinal haemorrhage	2/223 (0.9%)
Haematemesis	2/223 (0.9%)
Inguinal hernia	1/223 (0.4%)
Intestinal perforation	1/223 (0.4%)
Mallory-weiss syndrome	1/223 (0.4%)
Nausea	3/223 (1.3%)
Oesophagitis	1/223 (0.4%)
Pancreatitis	2/223 (0.9%)
Peritoneal haemorrhage	1/223 (0.4%)
Pneumatosis intestinalis	1/223 (0.4%)
Small intestinal obstruction	1/223 (0.4%)
Subileus	1/223 (0.4%)
Vomiting	7/223 (3.1%)
General disorders
Asthenia	3/223 (1.3%)
Chest pain	2/223 (0.9%)
Disease progression	12/223 (5.4%)
Fatigue	1/223 (0.4%)
Gait disturbance	1/223 (0.4%)
General physical health deterioration	5/223 (2.2%)
Generalised oedema	1/223 (0.4%)
Mucosal inflammation	1/223 (0.4%)
Oedema	1/223 (0.4%)
Pyrexia	5/223 (2.2%)
Sudden death	1/223 (0.4%)
Hepatobiliary disorders
Biliary colic	1/223 (0.4%)
Cholangitis	1/223 (0.4%)
Cholecystitis acute	2/223 (0.9%)
Hepatic failure	1/223 (0.4%)
Jaundice	2/223 (0.9%)
Jaundice cholestatic	1/223 (0.4%)
Infections and infestations
Bronchitis	1/223 (0.4%)
Gastroenteritis	1/223 (0.4%)
Infection	1/223 (0.4%)
Lymphangitis	1/223 (0.4%)
Pneumonia	2/223 (0.9%)
Pneumonia bacterial	1/223 (0.4%)
Sepsis	1/223 (0.4%)
Urinary tract infection	2/223 (0.9%)
Urosepsis	1/223 (0.4%)
Injury, poisoning and procedural complications
Joint dislocation	1/223 (0.4%)
Pelvic fracture	1/223 (0.4%)
Road traffic accident	1/223 (0.4%)
Ulna fracture	1/223 (0.4%)
Investigations
Alanine aminotransferase increased	1/223 (0.4%)
Blood calcium increased	1/223 (0.4%)
Ejection fraction decreased	1/223 (0.4%)
Weight decreased	1/223 (0.4%)
Lipase increased	1/223 (0.4%)
Metabolism and nutrition disorders
Acidosis	1/223 (0.4%)
Decreased appetite	3/223 (1.3%)
Dehydration	2/223 (0.9%)
Hypoglycaemia	1/223 (0.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	4/223 (1.8%)
Back pain	3/223 (1.3%)
Flank pain	1/223 (0.4%)
Intervertebral disc protrusion	1/223 (0.4%)
Osteonecrosis of jaw	1/223 (0.4%)
Pain in extremity	1/223 (0.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	1/223 (0.4%)
Breast cancer	1/223 (0.4%)
Chronic myeloid leukaemia	1/223 (0.4%)
Infected neoplasm	1/223 (0.4%)
Lymphangiosis carcinomatosa	1/223 (0.4%)
Prostate cancer	1/223 (0.4%)
Tumour haemorrhage	1/223 (0.4%)
Nervous system disorders
Convulsion	1/223 (0.4%)
Encephalopathy	1/223 (0.4%)
Hepatic encephalopathy	1/223 (0.4%)
Lethargy	1/223 (0.4%)
Metabolic encephalopathy	1/223 (0.4%)
Psychiatric disorders
Confusional state	1/223 (0.4%)
Depression	1/223 (0.4%)
Mental status changes	1/223 (0.4%)
Suicide attempt	1/223 (0.4%)
Renal and urinary disorders
Renal failure	1/223 (0.4%)
Renal failure acute	2/223 (0.9%)
Reproductive system and breast disorders
Scrotal erythema	1/223 (0.4%)
Respiratory, thoracic and mediastinal disorders
Cough	1/223 (0.4%)
Dyspnoea	3/223 (1.3%)
Epistaxis	2/223 (0.9%)
Lung disorder	1/223 (0.4%)
Pleural effusion	1/223 (0.4%)
Pneumothorax	2/223 (0.9%)
Pulmonary embolism	2/223 (0.9%)
Respiratory failure	1/223 (0.4%)
Skin and subcutaneous tissue disorders
Rash	1/223 (0.4%)
Skin exfoliation	1/223 (0.4%)
Vascular disorders
Aortic dissection	1/223 (0.4%)
Hypertension	1/223 (0.4%)
Pelvic venous thrombosis	1/223 (0.4%)
Thrombosis	1/223 (0.4%)
Venous thrombosis limb	1/223 (0.4%)
Other (Not Including Serious) Adverse Events
	Sunitinib
	Affected / at Risk (%)	# Events
Total	219/223 (98.2%)
Blood and lymphatic system disorders
Anaemia	41/223 (18.4%)
Leukopenia	35/223 (15.7%)
Neutropenia	76/223 (34.1%)
Thrombocytopenia	57/223 (25.6%)
Endocrine disorders
Hypothyroidism	24/223 (10.8%)
Eye disorders
Lacrimation increased	13/223 (5.8%)
Gastrointestinal disorders
Abdominal distention	20/223 (9%)
Abdominal pain	62/223 (27.8%)
Abdominal pain upper	46/223 (20.6%)
Constipation	41/223 (18.4%)
Diarrhoea	142/223 (63.7%)
Dry mouth	14/223 (6.3%)
Dyspepsia	36/223 (16.1%)
Gastritis	13/223 (5.8%)
Gastrooesophageal reflux disease	14/223 (6.3%)
Haemorrhoids	13/223 (5.8%)
Nausea	77/223 (34.5%)
Stomatitis	39/223 (17.5%)
Vomiting	61/223 (27.4%)
General disorders
Asthenia	67/223 (30%)
Chest pain	14/223 (6.3%)
Face oedema	17/223 (7.6%)
Fatigue	83/223 (37.2%)
Mucosal inflammation	58/223 (26%)
Oedema peripheral	30/223 (13.5%)
Pain	13/223 (5.8%)
Pyrexia	26/223 (11.7%)
Infections and infestations
Gingivitis	12/223 (5.4%)
Nasopharyngitis	18/223 (8.1%)
Upper respiratory tract infection	17/223 (7.6%)
Investigations
Alanine aminotransferase increased	21/223 (9.4%)
Aspartate aminotransferase increased	15/223 (6.7%)
Blood creatinine increased	13/223 (5.8%)
Haemoglobin decreased	20/223 (9%)
Neutrophil count decreased	16/223 (7.2%)
Platelet count decreased	19/223 (8.5%)
Weight decreased	36/223 (16.1%)
Metabolism and nutrition disorders
Decreased appetite	76/223 (34.1%)
Hyperglycaemia	13/223 (5.8%)
Hypoalbuminaemia	12/223 (5.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	31/223 (13.9%)
Back pain	47/223 (21.1%)
Bone pain	12/223 (5.4%)
Muscle spasms	18/223 (8.1%)
Myalgia	24/223 (10.8%)
Pain in extremity	36/223 (16.1%)
Nervous system disorders
Dizziness	16/223 (7.2%)
Dysgeusia	60/223 (26.9%)
Headache	44/223 (19.7%)
Psychiatric disorders
Depression	14/223 (6.3%)
Insomnia	35/223 (15.7%)
Respiratory, thoracic and mediastinal disorders
Cough	35/223 (15.7%)
Dyspnoea	44/223 (19.7%)
Epistaxis	43/223 (19.3%)
Oropharyngeal pain	19/223 (8.5%)
Pleural effusion	14/223 (6.3%)
Skin and subcutaneous tissue disorders
Alopecia	17/223 (7.6%)
Dry skin	21/223 (9.4%)
Erythema	19/223 (8.5%)
Hair colour changes	55/223 (24.7%)
Hyperkeratosis	13/223 (5.8%)
Palmar-plantar erythrodysaesthesia syndrome	83/223 (37.2%)
Rash	30/223 (13.5%)
Skin discolouration	26/223 (11.7%)
Yellow skin	22/223 (9.9%)
Vascular disorders
Hypertension	64/223 (28.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.