Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer

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ClinicalTrials.gov Identifier: NCT00699374

Recruitment Status : Terminated (See termination reason in detailed description.)

First Posted : June 18, 2008

Results First Posted : January 14, 2013

Last Update Posted : January 14, 2013

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Pfizer

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Carcinoma, Hepatocellular
Interventions	Drug: sunitinib malate Drug: sorafenib
Enrollment	1075

Participant Flow

Recruitment Details
Pre-assignment Details	One participant was randomized twice, once to the sorafenib arm and discontinued prior to receiving treatment and a second randomization to the sunitinib arm and dispensed treatment.


Arm/Group Title	Sunitinib	Sorafenib
Arm/Group Description	Participants received sunitinib 37....	Participants received sorafenib 400...
Arm/Group Description	Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.	Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
Period Title: Overall Study
Started	530	544
Treated	526	542
Completed	0	0
Not Completed	530	544
Reason Not Completed
Death	93	83
Adverse Event	70	67
Global deterioration of health status	7	8
Lost to Follow-up	3	5
Withdrawal by Subject	34	44
Objective progression or relapse	281	277
Other	18	15
Protocol Violation	2	6
Study terminated by sponsor	13	28
Randomized but not treated	4	2
Died 28 days after last dose	5	9

Baseline Characteristics

Arm/Group Title		Sunitinib	Sorafenib	Total
Arm/Group Description		Participants received sunitinib 37....	Participants received sorafenib 400...	Total of all reporting groups
Arm/Group Description		Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.	Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.	Total of all reporting groups
Overall Number of Baseline Participants		530	544	1074
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	530 participants	544 participants	1074 participants
		58.1 (12.86)	58.5 (12.93)	58.3 (12.89)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	530 participants	544 participants	1074 participants
	Female	94 17.7%	85 15.6%	179 16.7%
	Male	436 82.3%	459 84.4%	895 83.3%

Outcome Measures

1.Primary Outcome


Title	Overall Survival (OS)
Description	Overall survival is the duration from randomization to death. For part...
Description	Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
Time Frame	Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150

Outcome Measure Data

Analysis Population Description

Full Analysis Population, all randomized participants where participants were classifed according to the randomized treatment arm regardless of what treatment, if any, was received.


Arm/Group Title	Sunitinib	Sorafenib
Arm/Group Description:	Participants received sunitinib 37....	Participants received sorafenib 400...
Arm/Group Description:	Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.	Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
Overall Number of Participants Analyzed	530	544
Overall Number of Units Analyzed Type of Units Analyzed: Events	431	388
Median (95% Confidence Interval) Unit of Measure: Weeks
	34.3 (31.9 to 39.9)	43.9 (38.1 to 48.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Sorafenib
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.9993
	Comments	One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior transarterial chemoembolization (TACE) and tumor invasion condition.
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.31
	Confidence Interval	(2-Sided) 95% 1.14 to 1.50
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Progression-Free Survival (PFS)
Description	The period from randomization until disease progression or death.
Description	The period from randomization until disease progression or death.
Time Frame	Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150

Outcome Measure Data

Analysis Population Description

Full Analysis Population


Arm/Group Title	Sunitinib	Sorafenib
Arm/Group Description:	Participants received sunitinib 37....	Participants received sorafenib 400...
Arm/Group Description:	Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.	Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
Overall Number of Participants Analyzed	530	544
Overall Number of Units Analyzed Type of Units Analyzed: Events	408	433
Median (95% Confidence Interval) Unit of Measure: Weeks
	15.3 (12.1 to 17.7)	12.6 (12.1 to 17.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Sorafenib
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.8857
	Comments	One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior TACE, and tumor invasion condition
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95% 0.99 to 1.30
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Time to Tumor Progression (TTP)
Description	Time in weeks from randomization to first documentation of objective t...
Description	Time in weeks from randomization to first documentation of objective tumor progression or death due to cancer, whichever comes first. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])
Time Frame	Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150

Outcome Measure Data

Analysis Population Description

Full Analysis Population


Arm/Group Title	Sunitinib	Sorafenib
Arm/Group Description:	Participants received sunitinib 37....	Participants received sorafenib 400...
Arm/Group Description:	Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.	Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
Overall Number of Participants Analyzed	530	544
Overall Number of Units Analyzed Type of Units Analyzed: Events	365	393
Median (95% Confidence Interval) Unit of Measure: Weeks
	17.7 (13.6 to 18.0)	15.4 (12.3 to 18.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sunitinib, Sorafenib
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.8459
	Comments	One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior TACE and tumor invasion condition
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.13
	Confidence Interval	(2-Sided) 95% 0.98 to 1.31
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	European Quality of Life (EQ-5D)- Health State Profile Utility Score
Description	EQ-5D: participant rated questionnaire to assess health-related qualit...
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula assigns a utility value for each domain in the profile. Score is transformed and results in a score range -0.594 to 1.000; higher score indicates better health state.
Time Frame	Day 1 of each cycle

Outcome Measure Data

Analysis Population Description

Data were not collected per Amendment 2 to the protocol removing collection for this endpoint.


Arm/Group Title	Sunitinib	Sorafenib
Arm/Group Description:	Participants received sunitinib 37....	Participants received sorafenib 400...
Arm/Group Description:	Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.	Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Arm/Group Title	Sunitinib	Sorafenib
Arm/Group Description	Participants received sunitinib 37....	Participants received sorafenib 400...
Arm/Group Description	Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.	Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
All-Cause Mortality
	Sunitinib	Sorafenib
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Sunitinib	Sorafenib
	Affected / at Risk (%)	Affected / at Risk (%)
Total	240/526 (45.63%)	204/542 (37.64%)
Blood and lymphatic system disorders
Anaemia ^* 1	10/526 (1.90%)	5/542 (0.92%)
Disseminated intravascular coagulation ^* 1	1/526 (0.19%)	1/542 (0.18%)
Febrile neutropenia ^* 1	3/526 (0.57%)	0/542 (0.00%)
Leukopenia ^* 1	1/526 (0.19%)	0/542 (0.00%)
Neutropenia ^* 1	2/526 (0.38%)	0/542 (0.00%)
Splenic infarction ^* 1	0/526 (0.00%)	1/542 (0.18%)
Thrombocytopenia ^* 1	12/526 (2.28%)	1/542 (0.18%)
Cardiac disorders
Angina pectoris ^* 1	0/526 (0.00%)	1/542 (0.18%)
Atrial fibrillation ^* 1	0/526 (0.00%)	2/542 (0.37%)
Bradycardia ^* 1	0/526 (0.00%)	1/542 (0.18%)
Cardiac arrest ^* 1	1/526 (0.19%)	0/542 (0.00%)
Cardiac failure ^* 1	1/526 (0.19%)	2/542 (0.37%)
Myocardial infarction ^* 1	1/526 (0.19%)	0/542 (0.00%)
Myocardial ischaemia ^* 1	0/526 (0.00%)	1/542 (0.18%)
Palpitations ^* 1	1/526 (0.19%)	0/542 (0.00%)
Supraventricular tachycardia ^* 1	0/526 (0.00%)	1/542 (0.18%)
Tachycardia ^* 1	1/526 (0.19%)	0/542 (0.00%)
Eye disorders
Cataract ^* 1	0/526 (0.00%)	1/542 (0.18%)
Diabetic retinopathy ^* 1	1/526 (0.19%)	0/542 (0.00%)
Gastrointestinal disorders
Abdominal hernia ^* 1	1/526 (0.19%)	0/542 (0.00%)
Abdominal pain ^* 1	6/526 (1.14%)	5/542 (0.92%)
Abdominal pain upper ^* 1	2/526 (0.38%)	5/542 (0.92%)
Ascites ^* 1	12/526 (2.28%)	6/542 (1.11%)
Cheilitis ^* 1	0/526 (0.00%)	1/542 (0.18%)
Constipation ^* 1	1/526 (0.19%)	1/542 (0.18%)
Diarrhoea ^* 1	10/526 (1.90%)	9/542 (1.66%)
Duodenal ulcer ^* 1	1/526 (0.19%)	2/542 (0.37%)
Duodenal ulcer haemorrhage ^* 1	1/526 (0.19%)	0/542 (0.00%)
Enteritis ^* 1	2/526 (0.38%)	0/542 (0.00%)
Faeces discoloured ^* 1	1/526 (0.19%)	0/542 (0.00%)
Gastric antral vascular ectasia ^* 1	0/526 (0.00%)	1/542 (0.18%)
Gastric haemorrhage ^* 1	0/526 (0.00%)	1/542 (0.18%)
Gastric ulcer ^* 1	2/526 (0.38%)	1/542 (0.18%)
Gastric ulcer haemorrhage ^* 1	1/526 (0.19%)	1/542 (0.18%)
Gastric varices haemorrhage ^* 1	1/526 (0.19%)	0/542 (0.00%)
Gastritis erosive ^* 1	1/526 (0.19%)	0/542 (0.00%)
Gastritis haemorrhagic ^* 1	1/526 (0.19%)	0/542 (0.00%)
Gastrointestinal haemorrhage ^* 1	12/526 (2.28%)	4/542 (0.74%)
Gastrooesophageal reflux disease ^* 1	1/526 (0.19%)	0/542 (0.00%)
Gingival bleeding ^* 1	3/526 (0.57%)	0/542 (0.00%)
Glossitis ^* 1	0/526 (0.00%)	1/542 (0.18%)
Haematemesis ^* 1	2/526 (0.38%)	0/542 (0.00%)
Haemorrhoidal haemorrhage ^* 1	1/526 (0.19%)	0/542 (0.00%)
Haemorrhoids ^* 1	0/526 (0.00%)	2/542 (0.37%)
Ileus ^* 1	2/526 (0.38%)	0/542 (0.00%)
Intestinal ischaemia ^* 1	0/526 (0.00%)	1/542 (0.18%)
Melaena ^* 1	1/526 (0.19%)	2/542 (0.37%)
Mesenteric vein thrombosis ^* 1	0/526 (0.00%)	1/542 (0.18%)
Nausea ^* 1	4/526 (0.76%)	2/542 (0.37%)
Oesophageal rupture ^* 1	1/526 (0.19%)	0/542 (0.00%)
Oesophageal ulcer ^* 1	1/526 (0.19%)	0/542 (0.00%)
Oesophageal ulcer haemorrhage ^* 1	1/526 (0.19%)	0/542 (0.00%)
Oesophageal varices haemorrhage ^* 1	3/526 (0.57%)	2/542 (0.37%)
Pancreatic enzyme abnormality ^* 1	0/526 (0.00%)	1/542 (0.18%)
Pancreatitis ^* 1	0/526 (0.00%)	1/542 (0.18%)
Pancreatitis acute ^* 1	2/526 (0.38%)	1/542 (0.18%)
Peritoneal haemorrhage ^* 1	0/526 (0.00%)	1/542 (0.18%)
Rectal haemorrhage ^* 1	2/526 (0.38%)	0/542 (0.00%)
Small intestinal haemorrhage ^* 1	1/526 (0.19%)	0/542 (0.00%)
Stomatitis ^* 1	1/526 (0.19%)	0/542 (0.00%)
Upper gastrointestinal haemorrhage ^* 1	11/526 (2.09%)	7/542 (1.29%)
Vomiting ^* 1	9/526 (1.71%)	4/542 (0.74%)
General disorders
Asthenia ^* 1	10/526 (1.90%)	3/542 (0.55%)
Chest pain ^* 1	1/526 (0.19%)	1/542 (0.18%)
Condition aggravated ^* 1	9/526 (1.71%)	6/542 (1.11%)
Death ^* 1	0/526 (0.00%)	1/542 (0.18%)
Device failure ^* 1	1/526 (0.19%)	0/542 (0.00%)
Disease progression ^* 1	55/526 (10.46%)	62/542 (11.44%)
Fatigue ^* 1	5/526 (0.95%)	4/542 (0.74%)
General physical health deterioration ^* 1	3/526 (0.57%)	6/542 (1.11%)
Generalised oedema ^* 1	1/526 (0.19%)	0/542 (0.00%)
Hyperthermia ^* 1	1/526 (0.19%)	0/542 (0.00%)
Malaise ^* 1	2/526 (0.38%)	0/542 (0.00%)
Multi-organ failure ^* 1	1/526 (0.19%)	1/542 (0.18%)
Oedema peripheral ^* 1	1/526 (0.19%)	0/542 (0.00%)
Pain ^* 1	0/526 (0.00%)	1/542 (0.18%)
Pyrexia ^* 1	15/526 (2.85%)	9/542 (1.66%)
Hepatobiliary disorders
Acute hepatic failure ^* 1	1/526 (0.19%)	0/542 (0.00%)
Bile duct obstruction ^* 1	0/526 (0.00%)	2/542 (0.37%)
Bile duct stone ^* 1	0/526 (0.00%)	1/542 (0.18%)
Biliary colic ^* 1	1/526 (0.19%)	0/542 (0.00%)
Cholangitis ^* 1	0/526 (0.00%)	1/542 (0.18%)
Cholangitis acute ^* 1	1/526 (0.19%)	0/542 (0.00%)
Cholecystitis ^* 1	1/526 (0.19%)	1/542 (0.18%)
Hepatic failure ^* 1	3/526 (0.57%)	5/542 (0.92%)
Hepatic function abnormal ^* 1	4/526 (0.76%)	4/542 (0.74%)
Hepatic haemorrhage ^* 1	1/526 (0.19%)	0/542 (0.00%)
Hepatitis ^* 1	0/526 (0.00%)	1/542 (0.18%)
Hepatorenal syndrome ^* 1	0/526 (0.00%)	2/542 (0.37%)
Hepatotoxicity ^* 1	1/526 (0.19%)	0/542 (0.00%)
Hyperbilirubinaemia ^* 1	3/526 (0.57%)	2/542 (0.37%)
Hypertransaminasaemia ^* 1	1/526 (0.19%)	0/542 (0.00%)
Jaundice ^* 1	1/526 (0.19%)	0/542 (0.00%)
Jaundice cholestatic ^* 1	1/526 (0.19%)	1/542 (0.18%)
Immune system disorders
Anaphylactic shock ^* 1	0/526 (0.00%)	1/542 (0.18%)
Hypersensitivity ^* 1	0/526 (0.00%)	1/542 (0.18%)
Infections and infestations
Abdominal infection ^* 1	0/526 (0.00%)	1/542 (0.18%)
Anal abscess ^* 1	1/526 (0.19%)	0/542 (0.00%)
Bacteraemia ^* 1	2/526 (0.38%)	0/542 (0.00%)
Biliary sepsis ^* 1	0/526 (0.00%)	1/542 (0.18%)
Bronchitis ^* 1	0/526 (0.00%)	1/542 (0.18%)
Bronchopneumonia ^* 1	0/526 (0.00%)	1/542 (0.18%)
Campylobacter infection ^* 1	0/526 (0.00%)	1/542 (0.18%)
Cellulitis ^* 1	2/526 (0.38%)	0/542 (0.00%)
Clostridium difficile colitis ^* 1	0/526 (0.00%)	1/542 (0.18%)
Escherichia sepsis ^* 1	1/526 (0.19%)	0/542 (0.00%)
Fungal oesophagitis ^* 1	1/526 (0.19%)	0/542 (0.00%)
Gastroenteritis ^* 1	2/526 (0.38%)	0/542 (0.00%)
Gastrointestinal infection ^* 1	0/526 (0.00%)	1/542 (0.18%)
Hepatitis B ^* 1	1/526 (0.19%)	0/542 (0.00%)
Herpes zoster ^* 1	0/526 (0.00%)	1/542 (0.18%)
Herpes zoster ophthalmic ^* 1	0/526 (0.00%)	1/542 (0.18%)
Infected skin ulcer ^* 1	0/526 (0.00%)	1/542 (0.18%)
Infection ^* 1	1/526 (0.19%)	1/542 (0.18%)
Infectious peritonitis ^* 1	1/526 (0.19%)	0/542 (0.00%)
Liver abscess ^* 1	1/526 (0.19%)	3/542 (0.55%)
Lung infection ^* 1	0/526 (0.00%)	1/542 (0.18%)
Osteomyelitis ^* 1	1/526 (0.19%)	0/542 (0.00%)
Perineal abscess ^* 1	0/526 (0.00%)	1/542 (0.18%)
Peritonitis bacterial ^* 1	2/526 (0.38%)	1/542 (0.18%)
Pneumonia ^* 1	4/526 (0.76%)	5/542 (0.92%)
Pulmonary tuberculosis ^* 1	0/526 (0.00%)	1/542 (0.18%)
Rash pustular ^* 1	0/526 (0.00%)	1/542 (0.18%)
Respiratory tract infection ^* 1	0/526 (0.00%)	1/542 (0.18%)
Scrotal abscess ^* 1	0/526 (0.00%)	1/542 (0.18%)
Sepsis ^* 1	6/526 (1.14%)	7/542 (1.29%)
Septic shock ^* 1	3/526 (0.57%)	0/542 (0.00%)
Tuberculosis ^* 1	1/526 (0.19%)	0/542 (0.00%)
Upper respiratory tract infection ^* 1	1/526 (0.19%)	1/542 (0.18%)
Urinary tract infection ^* 1	2/526 (0.38%)	1/542 (0.18%)
Veillonella infection ^* 1	0/526 (0.00%)	1/542 (0.18%)
Injury, poisoning and procedural complications
Clavicle fracture ^* 1	1/526 (0.19%)	0/542 (0.00%)
Concussion ^* 1	0/526 (0.00%)	1/542 (0.18%)
Cystitis radiation ^* 1	1/526 (0.19%)	0/542 (0.00%)
Fall ^* 1	0/526 (0.00%)	1/542 (0.18%)
Femur fracture ^* 1	0/526 (0.00%)	1/542 (0.18%)
Fracture ^* 1	0/526 (0.00%)	1/542 (0.18%)
Ligament sprain ^* 1	0/526 (0.00%)	1/542 (0.18%)
Radius fracture ^* 1	1/526 (0.19%)	0/542 (0.00%)
Thoracic vertebral fracture ^* 1	0/526 (0.00%)	1/542 (0.18%)
Traumatic liver injury ^* 1	0/526 (0.00%)	1/542 (0.18%)
Ulna fracture ^* 1	1/526 (0.19%)	0/542 (0.00%)
Investigations
Alanine aminotransferase increased ^* 1	0/526 (0.00%)	1/542 (0.18%)
Aspartate aminotransferase increased ^* 1	0/526 (0.00%)	2/542 (0.37%)
Blood bilirubin increased ^* 1	0/526 (0.00%)	1/542 (0.18%)
Hepatic enzyme increased ^* 1	0/526 (0.00%)	1/542 (0.18%)
Liver function test abnormal ^* 1	0/526 (0.00%)	2/542 (0.37%)
Neutrophil count decreased ^* 1	1/526 (0.19%)	0/542 (0.00%)
Platelet count decreased ^* 1	4/526 (0.76%)	1/542 (0.18%)
White blood cell count decreased ^* 1	1/526 (0.19%)	0/542 (0.00%)
Metabolism and nutrition disorders
Decreased appetite ^* 1	8/526 (1.52%)	4/542 (0.74%)
Dehydration ^* 1	8/526 (1.52%)	3/542 (0.55%)
Hyperammonaemia ^* 1	1/526 (0.19%)	0/542 (0.00%)
Hyperkalaemia ^* 1	1/526 (0.19%)	1/542 (0.18%)
Hypoalbuminaemia ^* 1	1/526 (0.19%)	1/542 (0.18%)
Hypoglycaemia ^* 1	3/526 (0.57%)	4/542 (0.74%)
Hyponatraemia ^* 1	3/526 (0.57%)	0/542 (0.00%)
Hypophagia ^* 1	1/526 (0.19%)	0/542 (0.00%)
Malnutrition ^* 1	0/526 (0.00%)	1/542 (0.18%)
Musculoskeletal and connective tissue disorders
Back pain ^* 1	1/526 (0.19%)	3/542 (0.55%)
Flank pain ^* 1	0/526 (0.00%)	1/542 (0.18%)
Musculoskeletal pain ^* 1	1/526 (0.19%)	0/542 (0.00%)
Pain in extremity ^* 1	0/526 (0.00%)	1/542 (0.18%)
Rhabdomyolysis ^* 1	0/526 (0.00%)	1/542 (0.18%)
Scoliosis ^* 1	0/526 (0.00%)	1/542 (0.18%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant ^* 1	2/526 (0.38%)	1/542 (0.18%)
Liver carcinoma ruptured ^* 1	2/526 (0.38%)	0/542 (0.00%)
Malignant pleural effusion ^* 1	0/526 (0.00%)	1/542 (0.18%)
Metastases to central nervous system ^* 1	1/526 (0.19%)	0/542 (0.00%)
Nervous system neoplasm ^* 1	0/526 (0.00%)	1/542 (0.18%)
Pharyngeal cancer stage unspecified ^* 1	1/526 (0.19%)	0/542 (0.00%)
Tumour associated fever ^* 1	0/526 (0.00%)	1/542 (0.18%)
Tumour haemorrhage ^* 1	4/526 (0.76%)	1/542 (0.18%)
Tumour pain ^* 1	1/526 (0.19%)	1/542 (0.18%)
Tumour rupture ^* 1	2/526 (0.38%)	1/542 (0.18%)
Nervous system disorders
Altered state of consciousness ^* 1	0/526 (0.00%)	1/542 (0.18%)
Cerebral artery embolism ^* 1	0/526 (0.00%)	1/542 (0.18%)
Cerebral haemorrhage ^* 1	2/526 (0.38%)	2/542 (0.37%)
Cerebral infarction ^* 1	2/526 (0.38%)	0/542 (0.00%)
Coma ^* 1	1/526 (0.19%)	0/542 (0.00%)
Convulsion ^* 1	1/526 (0.19%)	0/542 (0.00%)
Diabetic hyperglycaemic coma ^* 1	0/526 (0.00%)	1/542 (0.18%)
Dizziness ^* 1	1/526 (0.19%)	0/542 (0.00%)
Encephalopathy ^* 1	1/526 (0.19%)	1/542 (0.18%)
Headache ^* 1	1/526 (0.19%)	0/542 (0.00%)
Hepatic encephalopathy ^* 1	15/526 (2.85%)	4/542 (0.74%)
Hypoaesthesia ^* 1	1/526 (0.19%)	0/542 (0.00%)
Hypoglycaemic coma ^* 1	1/526 (0.19%)	1/542 (0.18%)
Hypoxic-ischaemic encephalopathy ^* 1	0/526 (0.00%)	1/542 (0.18%)
Lacunar infarction ^* 1	1/526 (0.19%)	0/542 (0.00%)
Loss of consciousness ^* 1	1/526 (0.19%)	0/542 (0.00%)
Paralysis ^* 1	0/526 (0.00%)	1/542 (0.18%)
Subarachnoid haemorrhage ^* 1	1/526 (0.19%)	0/542 (0.00%)
Syncope ^* 1	2/526 (0.38%)	1/542 (0.18%)
Psychiatric disorders
Alcohol withdrawal syndrome ^* 1	1/526 (0.19%)	0/542 (0.00%)
Alcoholism ^* 1	1/526 (0.19%)	0/542 (0.00%)
Confusional state ^* 1	0/526 (0.00%)	1/542 (0.18%)
Suicide attempt ^* 1	1/526 (0.19%)	0/542 (0.00%)
Renal and urinary disorders
Haematuria ^* 1	1/526 (0.19%)	0/542 (0.00%)
Nephrolithiasis ^* 1	1/526 (0.19%)	0/542 (0.00%)
Nephrotic syndrome ^* 1	0/526 (0.00%)	1/542 (0.18%)
Proteinuria ^* 1	1/526 (0.19%)	0/542 (0.00%)
Renal failure ^* 1	4/526 (0.76%)	1/542 (0.18%)
Renal failure acute ^* 1	2/526 (0.38%)	1/542 (0.18%)
Renal impairment ^* 1	2/526 (0.38%)	0/542 (0.00%)
Renal tubular necrosis ^* 1	0/526 (0.00%)	1/542 (0.18%)
Urinary retention ^* 1	1/526 (0.19%)	0/542 (0.00%)
Reproductive system and breast disorders
Scrotal erythema ^* 1	1/526 (0.19%)	0/542 (0.00%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema ^* 1	1/526 (0.19%)	0/542 (0.00%)
Acute respiratory failure ^* 1	0/526 (0.00%)	2/542 (0.37%)
Apnoea ^* 1	0/526 (0.00%)	1/542 (0.18%)
Asphyxia ^* 1	1/526 (0.19%)	0/542 (0.00%)
Aspiration ^* 1	0/526 (0.00%)	1/542 (0.18%)
Bronchospasm ^* 1	0/526 (0.00%)	1/542 (0.18%)
Chronic obstructive pulmonary disease ^* 1	1/526 (0.19%)	0/542 (0.00%)
Dyspnoea ^* 1	4/526 (0.76%)	4/542 (0.74%)
Epistaxis ^* 1	2/526 (0.38%)	0/542 (0.00%)
Haemoptysis ^* 1	3/526 (0.57%)	1/542 (0.18%)
Hiccups ^* 1	0/526 (0.00%)	1/542 (0.18%)
Interstitial lung disease ^* 1	0/526 (0.00%)	1/542 (0.18%)
Lung disorder ^* 1	1/526 (0.19%)	1/542 (0.18%)
Pharyngeal haemorrhage ^* 1	1/526 (0.19%)	0/542 (0.00%)
Pleural effusion ^* 1	2/526 (0.38%)	1/542 (0.18%)
Pneumomediastinum ^* 1	1/526 (0.19%)	0/542 (0.00%)
Pneumonia aspiration ^* 1	1/526 (0.19%)	0/542 (0.00%)
Pneumothorax ^* 1	2/526 (0.38%)	1/542 (0.18%)
Pulmonary alveolar haemorrhage ^* 1	0/526 (0.00%)	1/542 (0.18%)
Pulmonary congestion ^* 1	0/526 (0.00%)	1/542 (0.18%)
Pulmonary embolism ^* 1	1/526 (0.19%)	2/542 (0.37%)
Respiratory failure ^* 1	1/526 (0.19%)	1/542 (0.18%)
Respiratory tract haemorrhage ^* 1	1/526 (0.19%)	0/542 (0.00%)
Upper respiratory tract inflammation ^* 1	1/526 (0.19%)	0/542 (0.00%)
Skin and subcutaneous tissue disorders
Drug eruption ^* 1	0/526 (0.00%)	1/542 (0.18%)
Hyperhidrosis ^* 1	1/526 (0.19%)	0/542 (0.00%)
Neuropathic ulcer ^* 1	1/526 (0.19%)	0/542 (0.00%)
Palmar-plantar erythrodysaesthesia syndrome ^* 1	6/526 (1.14%)	3/542 (0.55%)
Rash ^* 1	0/526 (0.00%)	2/542 (0.37%)
Skin exfoliation ^* 1	1/526 (0.19%)	0/542 (0.00%)
Skin ulcer ^* 1	0/526 (0.00%)	2/542 (0.37%)
Toxic skin eruption ^* 1	0/526 (0.00%)	1/542 (0.18%)
Vascular disorders
Bleeding varicose vein ^* 1	1/526 (0.19%)	0/542 (0.00%)
Deep vein thrombosis ^* 1	1/526 (0.19%)	0/542 (0.00%)
Haemorrhage ^* 1	1/526 (0.19%)	2/542 (0.37%)
Hypertension ^* 1	1/526 (0.19%)	0/542 (0.00%)
Hypertensive crisis ^* 1	1/526 (0.19%)	0/542 (0.00%)
Inferior vena caval occlusion ^* 1	1/526 (0.19%)	0/542 (0.00%)
Intra-abdominal haemorrhage ^* 1	1/526 (0.19%)	0/542 (0.00%)
Peripheral ischaemia ^* 1	1/526 (0.19%)	0/542 (0.00%)
Phlebitis ^* 1	0/526 (0.00%)	1/542 (0.18%)
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA 14.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Sunitinib	Sorafenib
	Affected / at Risk (%)	Affected / at Risk (%)
Total	515/526 (97.91%)	531/542 (97.97%)
Blood and lymphatic system disorders
Anaemia ^* 1	79/526 (15.02%)	47/542 (8.67%)
Leukopenia ^* 1	96/526 (18.25%)	37/542 (6.83%)
Neutropenia ^* 1	119/526 (22.62%)	19/542 (3.51%)
Thrombocytopenia ^* 1	170/526 (32.32%)	69/542 (12.73%)
Endocrine disorders
Hypothyroidism ^* 1	30/526 (5.70%)	7/542 (1.29%)
Gastrointestinal disorders
Abdominal distension ^* 1	90/526 (17.11%)	56/542 (10.33%)
Abdominal pain ^* 1	121/526 (23.00%)	105/542 (19.37%)
Abdominal pain upper ^* 1	74/526 (14.07%)	78/542 (14.39%)
Ascites ^* 1	76/526 (14.45%)	64/542 (11.81%)
Constipation ^* 1	90/526 (17.11%)	81/542 (14.94%)
Diarrhoea ^* 1	248/526 (47.15%)	254/542 (46.86%)
Dyspepsia ^* 1	53/526 (10.08%)	39/542 (7.20%)
Mouth ulceration ^* 1	28/526 (5.32%)	18/542 (3.32%)
Nausea ^* 1	129/526 (24.52%)	93/542 (17.16%)
Stomatitis ^* 1	87/526 (16.54%)	53/542 (9.78%)
Vomiting ^* 1	103/526 (19.58%)	61/542 (11.25%)
General disorders
Asthenia ^* 1	78/526 (14.83%)	60/542 (11.07%)
Chest pain ^* 1	21/526 (3.99%)	30/542 (5.54%)
Face oedema ^* 1	35/526 (6.65%)	5/542 (0.92%)
Fatigue ^* 1	171/526 (32.51%)	115/542 (21.22%)
Mucosal inflammation ^* 1	65/526 (12.36%)	39/542 (7.20%)
Oedema ^* 1	46/526 (8.75%)	23/542 (4.24%)
Oedema peripheral ^* 1	71/526 (13.50%)	46/542 (8.49%)
Pain ^* 1	25/526 (4.75%)	29/542 (5.35%)
Pyrexia ^* 1	105/526 (19.96%)	101/542 (18.63%)
Hepatobiliary disorders
Hyperbilirubinaemia ^* 1	59/526 (11.22%)	43/542 (7.93%)
Investigations
Alanine aminotransferase increased ^* 1	60/526 (11.41%)	70/542 (12.92%)
Aspartate aminotransferase increased ^* 1	84/526 (15.97%)	92/542 (16.97%)
Blood bilirubin increased ^* 1	30/526 (5.70%)	30/542 (5.54%)
Gamma-glutamyltransferase increased ^* 1	17/526 (3.23%)	28/542 (5.17%)
Neutrophil count decreased ^* 1	50/526 (9.51%)	4/542 (0.74%)
Platelet count ^* 1	29/526 (5.51%)	9/542 (1.66%)
Platelet count decreased ^* 1	65/526 (12.36%)	16/542 (2.95%)
Weight decreased ^* 1	44/526 (8.37%)	115/542 (21.22%)
White blood cell count decreased ^* 1	45/526 (8.56%)	5/542 (0.92%)
Metabolism and nutrition disorders
Decreased appetite ^* 1	233/526 (44.30%)	187/542 (34.50%)
Hypoalbuminaemia ^* 1	47/526 (8.94%)	42/542 (7.75%)
Musculoskeletal and connective tissue disorders
Back pain ^* 1	46/526 (8.75%)	40/542 (7.38%)
Pain in extremity ^* 1	14/526 (2.66%)	27/542 (4.98%)
Nervous system disorders
Dizziness ^* 1	48/526 (9.13%)	17/542 (3.14%)
Dysgeusia ^* 1	69/526 (13.12%)	15/542 (2.77%)
Headache ^* 1	43/526 (8.17%)	40/542 (7.38%)
Psychiatric disorders
Insomnia ^* 1	60/526 (11.41%)	54/542 (9.96%)
Renal and urinary disorders
Proteinuria ^* 1	44/526 (8.37%)	38/542 (7.01%)
Respiratory, thoracic and mediastinal disorders
Cough ^* 1	77/526 (14.64%)	62/542 (11.44%)
Dysphonia ^* 1	10/526 (1.90%)	49/542 (9.04%)
Dyspnoea ^* 1	53/526 (10.08%)	32/542 (5.90%)
Epistaxis ^* 1	63/526 (11.98%)	25/542 (4.61%)
Oropharyngeal pain ^* 1	30/526 (5.70%)	19/542 (3.51%)
Skin and subcutaneous tissue disorders
Alopecia ^* 1	19/526 (3.61%)	154/542 (28.41%)
Palmar-plantar erythrodysaesthesia syndrome ^* 1	232/526 (44.11%)	330/542 (60.89%)
Pruritus ^* 1	34/526 (6.46%)	58/542 (10.70%)
Rash ^* 1	108/526 (20.53%)	147/542 (27.12%)
Yellow skin ^* 1	37/526 (7.03%)	0/542 (0.00%)
Vascular disorders
Hypertension ^* 1	109/526 (20.72%)	95/542 (17.53%)
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA 14.1

Limitations and Caveats

Study terminated early due to futility. Subsequently, EQ-5D data were not collected or analyzed.

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Pfizer ClinicalTrials.gov Call Center
Organization:	Pfizer, Inc.
Phone:	1-800-718-1021
EMail:	ClinicalTrials.gov_Inquiries@pfizer.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Abuhelwa AY, Badaoui S, Yuen HY, McKinnon RA, Ruanglertboon W, Shankaran K, Tuteja A, Sorich MJ, Hopkins AM. A clinical scoring tool validated with machine learning for predicting severe hand-foot syndrome from sorafenib in hepatocellular carcinoma. Cancer Chemother Pharmacol. 2022 Apr;89(4):479-485. doi: 10.1007/s00280-022-04411-9. Epub 2022 Feb 28.

Cheng AL, Kang YK, Lin DY, Park JW, Kudo M, Qin S, Chung HC, Song X, Xu J, Poggi G, Omata M, Pitman Lowenthal S, Lanzalone S, Yang L, Lechuga MJ, Raymond E. Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial. J Clin Oncol. 2013 Nov 10;31(32):4067-75. doi: 10.1200/JCO.2012.45.8372. Epub 2013 Sep 30.

Koeberle D, Montemurro M, Samaras P, Majno P, Simcock M, Limacher A, Lerch S, Kovacs K, Inauen R, Hess V, Saletti P, Borner M, Roth A, Bodoky G. Continuous Sunitinib treatment in patients with advanced hepatocellular carcinoma: a Swiss Group for Clinical Cancer Research (SAKK) and Swiss Association for the Study of the Liver (SASL) multicenter phase II trial (SAKK 77/06). Oncologist. 2010;15(3):285-92. doi: 10.1634/theoncologist.2009-0316. Epub 2010 Mar 4.

Layout table for additonal information

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00699374
Other Study ID Numbers:	A6181170
First Submitted:	June 16, 2008
First Posted:	June 18, 2008
Results First Submitted:	December 7, 2012
Results First Posted:	January 14, 2013
Last Update Posted:	January 14, 2013

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