Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
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
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
Hide 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
Arm/Group Title Sunitinib Sorafenib Total
Hide 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
Hide 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%
1.Primary Outcome
Title Overall Survival (OS)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population
Arm/Group Title Sunitinib Sorafenib
Hide 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)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population
Arm/Group Title Sunitinib Sorafenib
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected per Amendment 2 to the protocol removing collection for this endpoint.
Arm/Group Title Sunitinib Sorafenib
Hide 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.
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
Hide 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   --/--   --/-- 
Hide 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
Hide 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
Study terminated early due to futility. Subsequently, EQ-5D data were not collected or analyzed.
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
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