Clincosm LogoSign in Get a demo

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

Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00699374
Collaborator
(none)
1,075
Enrollment
171
Locations
2
Arms
41
Duration (Months)
6.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be given until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of study treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This study was terminated on April 22th, 2010, based on a higher incidence of serious adverse events in the sunitinib arm compared to the sorafenib arm, and the fact that sunitinib did not meet the criteria to demonstrate that it was either superior or non-inferior to sorafenib in the survival of patients with advanced hepatocellular cancer. Patients on sunitinib who are judged by the investigator as receiving clinical benefit may chose to remain on study and continue treatment with sunitinib until clinical benefit as per the investigator's judgment.

Study Design

Study Type:
Interventional
Actual Enrollment :
1075 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

sunitinib arm

Drug: sunitinib malate
sunitinib capsules at starting dose of 37.5 mg PO daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sunitinib dosing interruptions and/or reductions are allowed based on patient tolerability.
Other Names:
  • Sutent®

    		•
    Active Comparator: Arm B

    sorafenib arm

    Drug: sorafenib
    sorafenib tablets at starting dose of 400 mg PO twice daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sorafenib dosing interruptions and/or reductions are allowed based on patient tolerability.
    Other Names:
  • Nexavar®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival (OS) [Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150]

      Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.

    Secondary Outcome Measures

    1. Progression-Free Survival (PFS) [Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150]

      The period from randomization until disease progression or death.

    2. Time to Tumor Progression (TTP) [Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150]

      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])

    3. European Quality of Life (EQ-5D)- Health State Profile Utility Score [Day 1 of each cycle]

      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.

    Eligibility Criteria

    Criteria

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

    • Histologically-confirmed diagnosis of hepatocellular carcinoma

    • presence of measurable disease by radiographic imaging

    • Child-Pugh class A

    • ECOG PS 0 or 1

    • adequate organ function.

    Exclusion Criteria:

    • Prior treatment with any systemic treatment for hepatocellular carcinoma

    • prior local treatment within 4 weeks from entry

    • presence of clinically relevant ascites

    • severe hemorrhage <4 weeks of starting study treatment

    • known HIV or serious acute or chronic illness

    • current treatment on another clinical trial

    • pregnancy or breastfeeding

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Fountain Valley California United States 92708
    2 Pfizer Investigational Site La Jolla California United States 92037
    3 Pfizer Investigational Site La Jolla California United States 92093
    4 Pfizer Investigational Site Orange California United States 92868
    5 Pfizer Investigational Site San Diego California United States 92103
    6 Pfizer Investigational Site Miami Florida United States 33136
    7 Pfizer Investigational Site Ringgold Georgia United States 30736
    8 Pfizer Investigational Site Iowa City Iowa United States 52242
    9 Pfizer Investigational Site Crestview Hills Kentucky United States 41017
    10 Pfizer Investigational Site Bronx New York United States 10467
    11 Pfizer Investigational Site Cincinnati Ohio United States 45219
    12 Pfizer Investigational Site Cincinnati Ohio United States 45230
    13 Pfizer Investigational Site Cincinnati Ohio United States 45236
    14 Pfizer Investigational Site Cincinnati Ohio United States 45238
    15 Pfizer Investigational Site Cincinnati Ohio United States 45242
    16 Pfizer Investigational Site Cincinnati Ohio United States 45248
    17 Pfizer Investigational Site Fairfield Ohio United States 45014
    18 Pfizer Investigational Site Hamilton Ohio United States 45013
    19 Pfizer Investigational Site Chattanooga Tennessee United States 37404
    20 Pfizer Investigational Site Franklin Tennessee United States 37067
    21 Pfizer Investigational Site Gallatin Tennessee United States 37066
    22 Pfizer Investigational Site Hermitage Tennessee United States 37076
    23 Pfizer Investigational Site Hixson Tennessee United States 37343
    24 Pfizer Investigational Site Lebanon Tennessee United States 37087
    25 Pfizer Investigational Site Murfreesboro Tennessee United States 37130
    26 Pfizer Investigational Site Nashville Tennessee United States 37203
    27 Pfizer Investigational Site Nashville Tennessee United States 37205
    28 Pfizer Investigational Site Nashville Tennessee United States 37207
    29 Pfizer Investigational Site Nashville Tennessee United States 37211
    30 Pfizer Investigational Site Smyrna Tennessee United States 37167
    31 Pfizer Investigational Site Mechanicsville Virginia United States 23116
    32 Pfizer Investigational Site Midlothian Virginia United States 23114
    33 Pfizer Investigational Site Richmond Virginia United States 23230
    34 Pfizer Investigational Site Richmond Virginia United States 23235-4730
    35 Pfizer Investigational Site Seattle Washington United States 98101
    36 Pfizer Investigational Site Concord New South Wales Australia 2139
    37 Pfizer Investigational Site Elizabeth Vale South Australia Australia 5112
    38 Pfizer Investigational Site Woodville South South Australia Australia 5011
    39 Pfizer Investigational Site Melbourne Victoria Australia 3004
    40 Pfizer Investigational Site Parkville Victoria Australia 3050
    41 Pfizer Investigational Site Bruxelles Belgium 1070
    42 Pfizer Investigational Site Bruxelles Belgium 1200
    43 Pfizer Investigational Site Gent Belgium 900
    44 Pfizer Investigational Site Calgary Alberta Canada T2N 4N2
    45 Pfizer Investigational Site Vancouver British Columbia Canada V5Z 4E6
    46 Pfizer Investigational Site Kingston Ontario Canada K7L 5P9
    47 Pfizer Investigational Site Toronto Ontario Canada M6R 1B5
    48 Pfizer Investigational Site Montreal Quebec Canada H2X 3J4
    49 Pfizer Investigational Site Hefei Anhui China 230022
    50 Pfizer Investigational Site Fuzhou City Fujian China 350014
    51 Pfizer Investigational Site Guangzhou Guangdong China 510060
    52 Pfizer Investigational Site Guangzhou Guangdong China 510080
    53 Pfizer Investigational Site Nanning Guangxi China 530021
    54 Pfizer Investigational Site Wuhan Hubei China 430030
    55 Pfizer Investigational Site Nanjing Jiangsu China 210002
    56 Pfizer Investigational Site Chengdu Sichuan China 610041
    57 Pfizer Investigational Site Hangzhou Zhejiang China 310016
    58 Pfizer Investigational Site Hangzhou Zhejiang China 310022
    59 Pfizer Investigational Site Beijing China 100035
    60 Pfizer Investigational Site Beijing China 100071
    61 Pfizer Investigational Site Bejing China 100021
    62 Pfizer Investigational Site Chong qing China 400038
    63 Pfizer Investigational Site Guangzhou China 510515
    64 Pfizer Investigational Site Nanjing China 210009
    65 Pfizer Investigational Site Shanghai China 200070
    66 Pfizer Investigational Site Amiens Cedex 1 France 80054
    67 Pfizer Investigational Site Bordeaux Cedex France 33075
    68 Pfizer Investigational Site Clichy Cedex France 92118
    69 Pfizer Investigational Site Creteil Cedex France 94010
    70 Pfizer Investigational Site Lille Cedex France 59037
    71 Pfizer Investigational Site Nice Cedex 2 France 06189
    72 Pfizer Investigational Site Paris Cedex 13 France 75651
    73 Pfizer Investigational Site Paris France 75012
    74 Pfizer Investigational Site St Herblain Cedex France 44805
    75 Pfizer Investigational Site Strasbourg Cedex France 67091
    76 Pfizer Investigational Site Toulouse France 31059
    77 Pfizer Investigational Site Vandoeuvre Les Nancy Cedex France 54511
    78 Pfizer Investigational Site Villejuif Cedex France 94804
    79 Pfizer Investigational Site Hamburg Germany 20246
    80 Pfizer Investigational Site Hannover Germany 30625
    81 Pfizer Investigational Site Mainz Germany 55131
    82 Pfizer Investigational Site Muenchen Germany 81377
    83 Pfizer Investigational Site Hong Hong Hong Kong
    84 Pfizer Investigational Site Kowloon Hong Kong
    85 Pfizer Investigational Site Shatin, New Territories Hong Kong
    86 Pfizer Investigational Site Tuen Mun, New Territories Hong Kong
    87 Pfizer Investigational Site Meldola FC Italy 47014
    88 Pfizer Investigational Site Bari Italy 70126
    89 Pfizer Investigational Site Bologna Italy 40138
    90 Pfizer Investigational Site Cattolica (RN) Italy 47841
    91 Pfizer Investigational Site Milano Italy 20122
    92 Pfizer Investigational Site Milano Italy 20132
    93 Pfizer Investigational Site Padova Italy 35128
    94 Pfizer Investigational Site Pavia Italy 27100
    95 Pfizer Investigational Site Ravenna Italy 48100
    96 Pfizer Investigational Site Rimini Italy 47900
    97 Pfizer Investigational Site Nagoya Aichi Japan
    98 Pfizer Investigational Site Chiba city Chiba Japan
    99 Pfizer Investigational Site Kashiwa-shi Chiba Japan
    100 Pfizer Investigational Site Kurume city Fukuoka Japan
    101 Pfizer Investigational Site Gifu-shi Gifu Japan
    102 Pfizer Investigational Site Sapporo-shi Hokkaido Japan
    103 Pfizer Investigational Site Nishinomiya Hyogo Japan
    104 Pfizer Investigational Site Kanazawa city Ishikawa Japan
    105 Pfizer Investigational Site Omura-shi Nagasaki Japan
    106 Pfizer Investigational Site Osaka-shi Osaka-fu Japan
    107 Pfizer Investigational Site Osaka-Sayama Osaka Japan
    108 Pfizer Investigational Site Izunokuni-shi Shizuoka Japan
    109 Pfizer Investigational Site Bunkyo-ku Tokyo Japan
    110 Pfizer Investigational Site Chiyoda-ku Tokyo Japan
    111 Pfizer Investigational Site Chuo-ku Tokyo Japan
    112 Pfizer Investigational Site Itabashi-ku Tokyo Japan
    113 Pfizer Investigational Site Mitaka-shi Tokyo Japan
    114 Pfizer Investigational Site Setagaya-ku Tokyo Japan
    115 Pfizer Investigational Site Okayama Japan
    116 Pfizer Investigational Site Chonju Chonbuk Korea, Republic of 561-712
    117 Pfizer Investigational Site Goyang-si Gyeonggi-do Korea, Republic of 411-769
    118 Pfizer Investigational Site Hwasun-gun Jeollanam-do Korea, Republic of 519-809
    119 Pfizer Investigational Site Busan Korea, Republic of 614-735
    120 Pfizer Investigational Site Daegu Korea, Republic of 700-712
    121 Pfizer Investigational Site Daegu Korea, Republic of 705-718
    122 Pfizer Investigational Site Incheon Korea, Republic of 405-760
    123 Pfizer Investigational Site Seoul Korea, Republic of 110-744
    124 Pfizer Investigational Site Seoul Korea, Republic of 120-752
    125 Pfizer Investigational Site Seoul Korea, Republic of 135-710
    126 Pfizer Investigational Site Seoul Korea, Republic of 138-736
    127 Pfizer Investigational Site Seoul Korea, Republic of 152-703
    128 Pfizer Investigational Site Lembah Pantai Kuala Lumpur Malaysia 59100
    129 Pfizer Investigational Site Subang Jaya Selangor Malaysia 47500
    130 Pfizer Investigational Site Kuala Lumpur Malaysia 50586
    131 Pfizer Investigational Site Cebu City Cebu Philippines 6000
    132 Pfizer Investigational Site Cebu City Philippines 6000
    133 Pfizer Investigational Site Davao City Philippines
    134 Pfizer Investigational Site Manila Philippines 1000
    135 Pfizer Investigational Site Manila Philippines 1015
    136 Pfizer Investigational Site Quezon City Philippines 1102
    137 Pfizer Investigational Site Quezon City Philippines 1104
    138 Pfizer Investigational Site Quezon City Philippines
    139 Pfizer Investigational Site Warszawa Poland 02-097
    140 Pfizer Investigational Site Warszawa Poland 02-781
    141 Pfizer Investigational Site Chelyabinsk Russian Federation 454087
    142 Pfizer Investigational Site Pyatigorsk Russian Federation 357502
    143 Pfizer Investigational Site St.Petersburg Russian Federation 194044
    144 Pfizer Investigational Site Singapore Singapore 119074
    145 Pfizer Investigational Site Singapore Singapore 169610
    146 Pfizer Investigational Site Parktown South Africa 2193
    147 Pfizer Investigational Site Sabadell Barcelona Spain 08208
    148 Pfizer Investigational Site Santander Cantabria Spain 39008
    149 Pfizer Investigational Site Palma de Mallorca Illes Balears Spain 07198
    150 Pfizer Investigational Site El Palmar Murcia Spain 30120
    151 Pfizer Investigational Site Sevilla Spain 41013
    152 Pfizer Investigational Site Linkoping Sweden 581 85
    153 Pfizer Investigational Site Pu-Tz City Chai-Yi Taiwan 613
    154 Pfizer Investigational Site Kwei-Shan Taoyuan Taiwan 333
    155 Pfizer Investigational Site Changhua Taiwan 500
    156 Pfizer Investigational Site Kaohsiung Taiwan 807
    157 Pfizer Investigational Site Kaohsiung Taiwan 833
    158 Pfizer Investigational Site Taichung City Taiwan 407
    159 Pfizer Investigational Site Taichung Taiwan 404
    160 Pfizer Investigational Site Tainan Taiwan 704
    161 Pfizer Investigational Site Tainan Taiwan 736
    162 Pfizer Investigational Site Taipei Taiwan 110
    163 Pfizer Investigational Site Taipei Taiwan 112
    164 Pfizer Investigational Site Bangkok Noi Bangkok Thailand 10700
    165 Pfizer Investigational Site Ptumwan Bangkok Thailand 10330
    166 Pfizer Investigational Site Amphoe Mueang Chiang Mai Thailand 50200
    167 Pfizer Investigational Site Ankara Turkey 06100
    168 Pfizer Investigational Site Istanbul Turkey
    169 Pfizer Investigational Site Cambridge Cambridgeshire United Kingdom CR2 0QQ
    170 Pfizer Investigational Site London United Kingdom W12 0NN
    171 Pfizer Investigational Site London United Kingdom W12 OHS

    Sponsors and Collaborators

    • Pfizer

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00699374
    Other Study ID Numbers:
    • A6181170
    First Posted:
    Jun 18, 2008
    Last Update Posted:
    Jan 14, 2013
    Last Verified:
    Dec 1, 2012
    Keywords provided by Pfizer
    sunitinib
    phase 3
    randomized
    hepatocellular
    liver
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Sorafenib
    Sunitinib

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 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 37.5 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

    Baseline Characteristics

    Arm/Group Title Sunitinib Sorafenib Total
    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 Participants 530 544 1074
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    58.1
    (12.86)
    58.5
    (12.93)
    58.3
    (12.89)
    Sex: Female, Male (Count of 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 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 37.5 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.
    Measure Participants 530 544
    Measure Events 431 388
    Median (95% Confidence Interval) [Weeks]
    34.3
    43.9
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sunitinib, Sorafenib
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    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
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.31
    Confidence Interval (2-Sided) 95%
    1.14 to 1.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Progression-Free Survival (PFS)
    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 37.5 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.
    Measure Participants 530 544
    Measure Events 408 433
    Median (95% Confidence Interval) [Weeks]
    15.3
    12.6
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sunitinib, Sorafenib
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    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
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.13
    Confidence Interval (2-Sided) 95%
    0.99 to 1.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Time to Tumor Progression (TTP)
    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 37.5 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.
    Measure Participants 530 544
    Measure Events 365 393
    Median (95% Confidence Interval) [Weeks]
    17.7
    15.4
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sunitinib, Sorafenib
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    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
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.13
    Confidence Interval (2-Sided) 95%
    0.98 to 1.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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 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 37.5 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.
    Measure Participants 0 0

    Adverse Events

    Time Frame
    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 37.5 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 (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Sunitinib Sorafenib
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 240/526 (45.6%) 204/542 (37.6%)
    Blood and lymphatic system disorders
    Anaemia 10/526 (1.9%) 5/542 (0.9%)
    Disseminated intravascular coagulation 1/526 (0.2%) 1/542 (0.2%)
    Febrile neutropenia 3/526 (0.6%) 0/542 (0%)
    Leukopenia 1/526 (0.2%) 0/542 (0%)
    Neutropenia 2/526 (0.4%) 0/542 (0%)
    Splenic infarction 0/526 (0%) 1/542 (0.2%)
    Thrombocytopenia 12/526 (2.3%) 1/542 (0.2%)
    Cardiac disorders
    Angina pectoris 0/526 (0%) 1/542 (0.2%)
    Atrial fibrillation 0/526 (0%) 2/542 (0.4%)
    Bradycardia 0/526 (0%) 1/542 (0.2%)
    Cardiac arrest 1/526 (0.2%) 0/542 (0%)
    Cardiac failure 1/526 (0.2%) 2/542 (0.4%)
    Myocardial infarction 1/526 (0.2%) 0/542 (0%)
    Myocardial ischaemia 0/526 (0%) 1/542 (0.2%)
    Palpitations 1/526 (0.2%) 0/542 (0%)
    Supraventricular tachycardia 0/526 (0%) 1/542 (0.2%)
    Tachycardia 1/526 (0.2%) 0/542 (0%)
    Eye disorders
    Cataract 0/526 (0%) 1/542 (0.2%)
    Diabetic retinopathy 1/526 (0.2%) 0/542 (0%)
    Gastrointestinal disorders
    Abdominal hernia 1/526 (0.2%) 0/542 (0%)
    Abdominal pain 6/526 (1.1%) 5/542 (0.9%)
    Abdominal pain upper 2/526 (0.4%) 5/542 (0.9%)
    Ascites 12/526 (2.3%) 6/542 (1.1%)
    Cheilitis 0/526 (0%) 1/542 (0.2%)
    Constipation 1/526 (0.2%) 1/542 (0.2%)
    Diarrhoea 10/526 (1.9%) 9/542 (1.7%)
    Duodenal ulcer 1/526 (0.2%) 2/542 (0.4%)
    Duodenal ulcer haemorrhage 1/526 (0.2%) 0/542 (0%)
    Enteritis 2/526 (0.4%) 0/542 (0%)
    Faeces discoloured 1/526 (0.2%) 0/542 (0%)
    Gastric antral vascular ectasia 0/526 (0%) 1/542 (0.2%)
    Gastric haemorrhage 0/526 (0%) 1/542 (0.2%)
    Gastric ulcer 2/526 (0.4%) 1/542 (0.2%)
    Gastric ulcer haemorrhage 1/526 (0.2%) 1/542 (0.2%)
    Gastric varices haemorrhage 1/526 (0.2%) 0/542 (0%)
    Gastritis erosive 1/526 (0.2%) 0/542 (0%)
    Gastritis haemorrhagic 1/526 (0.2%) 0/542 (0%)
    Gastrointestinal haemorrhage 12/526 (2.3%) 4/542 (0.7%)
    Gastrooesophageal reflux disease 1/526 (0.2%) 0/542 (0%)
    Gingival bleeding 3/526 (0.6%) 0/542 (0%)
    Glossitis 0/526 (0%) 1/542 (0.2%)
    Haematemesis 2/526 (0.4%) 0/542 (0%)
    Haemorrhoidal haemorrhage 1/526 (0.2%) 0/542 (0%)
    Haemorrhoids 0/526 (0%) 2/542 (0.4%)
    Ileus 2/526 (0.4%) 0/542 (0%)
    Intestinal ischaemia 0/526 (0%) 1/542 (0.2%)
    Melaena 1/526 (0.2%) 2/542 (0.4%)
    Mesenteric vein thrombosis 0/526 (0%) 1/542 (0.2%)
    Nausea 4/526 (0.8%) 2/542 (0.4%)
    Oesophageal rupture 1/526 (0.2%) 0/542 (0%)
    Oesophageal ulcer 1/526 (0.2%) 0/542 (0%)
    Oesophageal ulcer haemorrhage 1/526 (0.2%) 0/542 (0%)
    Oesophageal varices haemorrhage 3/526 (0.6%) 2/542 (0.4%)
    Pancreatic enzyme abnormality 0/526 (0%) 1/542 (0.2%)
    Pancreatitis 0/526 (0%) 1/542 (0.2%)
    Pancreatitis acute 2/526 (0.4%) 1/542 (0.2%)
    Peritoneal haemorrhage 0/526 (0%) 1/542 (0.2%)
    Rectal haemorrhage 2/526 (0.4%) 0/542 (0%)
    Small intestinal haemorrhage 1/526 (0.2%) 0/542 (0%)
    Stomatitis 1/526 (0.2%) 0/542 (0%)
    Upper gastrointestinal haemorrhage 11/526 (2.1%) 7/542 (1.3%)
    Vomiting 9/526 (1.7%) 4/542 (0.7%)
    General disorders
    Asthenia 10/526 (1.9%) 3/542 (0.6%)
    Chest pain 1/526 (0.2%) 1/542 (0.2%)
    Condition aggravated 9/526 (1.7%) 6/542 (1.1%)
    Death 0/526 (0%) 1/542 (0.2%)
    Device failure 1/526 (0.2%) 0/542 (0%)
    Disease progression 55/526 (10.5%) 62/542 (11.4%)
    Fatigue 5/526 (1%) 4/542 (0.7%)
    General physical health deterioration 3/526 (0.6%) 6/542 (1.1%)
    Generalised oedema 1/526 (0.2%) 0/542 (0%)
    Hyperthermia 1/526 (0.2%) 0/542 (0%)
    Malaise 2/526 (0.4%) 0/542 (0%)
    Multi-organ failure 1/526 (0.2%) 1/542 (0.2%)
    Oedema peripheral 1/526 (0.2%) 0/542 (0%)
    Pain 0/526 (0%) 1/542 (0.2%)
    Pyrexia 15/526 (2.9%) 9/542 (1.7%)
    Hepatobiliary disorders
    Acute hepatic failure 1/526 (0.2%) 0/542 (0%)
    Bile duct obstruction 0/526 (0%) 2/542 (0.4%)
    Bile duct stone 0/526 (0%) 1/542 (0.2%)
    Biliary colic 1/526 (0.2%) 0/542 (0%)
    Cholangitis 0/526 (0%) 1/542 (0.2%)
    Cholangitis acute 1/526 (0.2%) 0/542 (0%)
    Cholecystitis 1/526 (0.2%) 1/542 (0.2%)
    Hepatic failure 3/526 (0.6%) 5/542 (0.9%)
    Hepatic function abnormal 4/526 (0.8%) 4/542 (0.7%)
    Hepatic haemorrhage 1/526 (0.2%) 0/542 (0%)
    Hepatitis 0/526 (0%) 1/542 (0.2%)
    Hepatorenal syndrome 0/526 (0%) 2/542 (0.4%)
    Hepatotoxicity 1/526 (0.2%) 0/542 (0%)
    Hyperbilirubinaemia 3/526 (0.6%) 2/542 (0.4%)
    Hypertransaminasaemia 1/526 (0.2%) 0/542 (0%)
    Jaundice 1/526 (0.2%) 0/542 (0%)
    Jaundice cholestatic 1/526 (0.2%) 1/542 (0.2%)
    Immune system disorders
    Anaphylactic shock 0/526 (0%) 1/542 (0.2%)
    Hypersensitivity 0/526 (0%) 1/542 (0.2%)
    Infections and infestations
    Abdominal infection 0/526 (0%) 1/542 (0.2%)
    Anal abscess 1/526 (0.2%) 0/542 (0%)
    Bacteraemia 2/526 (0.4%) 0/542 (0%)
    Biliary sepsis 0/526 (0%) 1/542 (0.2%)
    Bronchitis 0/526 (0%) 1/542 (0.2%)
    Bronchopneumonia 0/526 (0%) 1/542 (0.2%)
    Campylobacter infection 0/526 (0%) 1/542 (0.2%)
    Cellulitis 2/526 (0.4%) 0/542 (0%)
    Clostridium difficile colitis 0/526 (0%) 1/542 (0.2%)
    Escherichia sepsis 1/526 (0.2%) 0/542 (0%)
    Fungal oesophagitis 1/526 (0.2%) 0/542 (0%)
    Gastroenteritis 2/526 (0.4%) 0/542 (0%)
    Gastrointestinal infection 0/526 (0%) 1/542 (0.2%)
    Hepatitis B 1/526 (0.2%) 0/542 (0%)
    Herpes zoster 0/526 (0%) 1/542 (0.2%)
    Herpes zoster ophthalmic 0/526 (0%) 1/542 (0.2%)
    Infected skin ulcer 0/526 (0%) 1/542 (0.2%)
    Infection 1/526 (0.2%) 1/542 (0.2%)
    Infectious peritonitis 1/526 (0.2%) 0/542 (0%)
    Liver abscess 1/526 (0.2%) 3/542 (0.6%)
    Lung infection 0/526 (0%) 1/542 (0.2%)
    Osteomyelitis 1/526 (0.2%) 0/542 (0%)
    Perineal abscess 0/526 (0%) 1/542 (0.2%)
    Peritonitis bacterial 2/526 (0.4%) 1/542 (0.2%)
    Pneumonia 4/526 (0.8%) 5/542 (0.9%)
    Pulmonary tuberculosis 0/526 (0%) 1/542 (0.2%)
    Rash pustular 0/526 (0%) 1/542 (0.2%)
    Respiratory tract infection 0/526 (0%) 1/542 (0.2%)
    Scrotal abscess 0/526 (0%) 1/542 (0.2%)
    Sepsis 6/526 (1.1%) 7/542 (1.3%)
    Septic shock 3/526 (0.6%) 0/542 (0%)
    Tuberculosis 1/526 (0.2%) 0/542 (0%)
    Upper respiratory tract infection 1/526 (0.2%) 1/542 (0.2%)
    Urinary tract infection 2/526 (0.4%) 1/542 (0.2%)
    Veillonella infection 0/526 (0%) 1/542 (0.2%)
    Injury, poisoning and procedural complications
    Clavicle fracture 1/526 (0.2%) 0/542 (0%)
    Concussion 0/526 (0%) 1/542 (0.2%)
    Cystitis radiation 1/526 (0.2%) 0/542 (0%)
    Fall 0/526 (0%) 1/542 (0.2%)
    Femur fracture 0/526 (0%) 1/542 (0.2%)
    Fracture 0/526 (0%) 1/542 (0.2%)
    Ligament sprain 0/526 (0%) 1/542 (0.2%)
    Radius fracture 1/526 (0.2%) 0/542 (0%)
    Thoracic vertebral fracture 0/526 (0%) 1/542 (0.2%)
    Traumatic liver injury 0/526 (0%) 1/542 (0.2%)
    Ulna fracture 1/526 (0.2%) 0/542 (0%)
    Investigations
    Alanine aminotransferase increased 0/526 (0%) 1/542 (0.2%)
    Aspartate aminotransferase increased 0/526 (0%) 2/542 (0.4%)
    Blood bilirubin increased 0/526 (0%) 1/542 (0.2%)
    Hepatic enzyme increased 0/526 (0%) 1/542 (0.2%)
    Liver function test abnormal 0/526 (0%) 2/542 (0.4%)
    Neutrophil count decreased 1/526 (0.2%) 0/542 (0%)
    Platelet count decreased 4/526 (0.8%) 1/542 (0.2%)
    White blood cell count decreased 1/526 (0.2%) 0/542 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 8/526 (1.5%) 4/542 (0.7%)
    Dehydration 8/526 (1.5%) 3/542 (0.6%)
    Hyperammonaemia 1/526 (0.2%) 0/542 (0%)
    Hyperkalaemia 1/526 (0.2%) 1/542 (0.2%)
    Hypoalbuminaemia 1/526 (0.2%) 1/542 (0.2%)
    Hypoglycaemia 3/526 (0.6%) 4/542 (0.7%)
    Hyponatraemia 3/526 (0.6%) 0/542 (0%)
    Hypophagia 1/526 (0.2%) 0/542 (0%)
    Malnutrition 0/526 (0%) 1/542 (0.2%)
    Musculoskeletal and connective tissue disorders
    Back pain 1/526 (0.2%) 3/542 (0.6%)
    Flank pain 0/526 (0%) 1/542 (0.2%)
    Musculoskeletal pain 1/526 (0.2%) 0/542 (0%)
    Pain in extremity 0/526 (0%) 1/542 (0.2%)
    Rhabdomyolysis 0/526 (0%) 1/542 (0.2%)
    Scoliosis 0/526 (0%) 1/542 (0.2%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatic neoplasm malignant 2/526 (0.4%) 1/542 (0.2%)
    Liver carcinoma ruptured 2/526 (0.4%) 0/542 (0%)
    Malignant pleural effusion 0/526 (0%) 1/542 (0.2%)
    Metastases to central nervous system 1/526 (0.2%) 0/542 (0%)
    Nervous system neoplasm 0/526 (0%) 1/542 (0.2%)
    Pharyngeal cancer stage unspecified 1/526 (0.2%) 0/542 (0%)
    Tumour associated fever 0/526 (0%) 1/542 (0.2%)
    Tumour haemorrhage 4/526 (0.8%) 1/542 (0.2%)
    Tumour pain 1/526 (0.2%) 1/542 (0.2%)
    Tumour rupture 2/526 (0.4%) 1/542 (0.2%)
    Nervous system disorders
    Altered state of consciousness 0/526 (0%) 1/542 (0.2%)
    Cerebral artery embolism 0/526 (0%) 1/542 (0.2%)
    Cerebral haemorrhage 2/526 (0.4%) 2/542 (0.4%)
    Cerebral infarction 2/526 (0.4%) 0/542 (0%)
    Coma 1/526 (0.2%) 0/542 (0%)
    Convulsion 1/526 (0.2%) 0/542 (0%)
    Diabetic hyperglycaemic coma 0/526 (0%) 1/542 (0.2%)
    Dizziness 1/526 (0.2%) 0/542 (0%)
    Encephalopathy 1/526 (0.2%) 1/542 (0.2%)
    Headache 1/526 (0.2%) 0/542 (0%)
    Hepatic encephalopathy 15/526 (2.9%) 4/542 (0.7%)
    Hypoaesthesia 1/526 (0.2%) 0/542 (0%)
    Hypoglycaemic coma 1/526 (0.2%) 1/542 (0.2%)
    Hypoxic-ischaemic encephalopathy 0/526 (0%) 1/542 (0.2%)
    Lacunar infarction 1/526 (0.2%) 0/542 (0%)
    Loss of consciousness 1/526 (0.2%) 0/542 (0%)
    Paralysis 0/526 (0%) 1/542 (0.2%)
    Subarachnoid haemorrhage 1/526 (0.2%) 0/542 (0%)
    Syncope 2/526 (0.4%) 1/542 (0.2%)
    Psychiatric disorders
    Alcohol withdrawal syndrome 1/526 (0.2%) 0/542 (0%)
    Alcoholism 1/526 (0.2%) 0/542 (0%)
    Confusional state 0/526 (0%) 1/542 (0.2%)
    Suicide attempt 1/526 (0.2%) 0/542 (0%)
    Renal and urinary disorders
    Haematuria 1/526 (0.2%) 0/542 (0%)
    Nephrolithiasis 1/526 (0.2%) 0/542 (0%)
    Nephrotic syndrome 0/526 (0%) 1/542 (0.2%)
    Proteinuria 1/526 (0.2%) 0/542 (0%)
    Renal failure 4/526 (0.8%) 1/542 (0.2%)
    Renal failure acute 2/526 (0.4%) 1/542 (0.2%)
    Renal impairment 2/526 (0.4%) 0/542 (0%)
    Renal tubular necrosis 0/526 (0%) 1/542 (0.2%)
    Urinary retention 1/526 (0.2%) 0/542 (0%)
    Reproductive system and breast disorders
    Scrotal erythema 1/526 (0.2%) 0/542 (0%)
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema 1/526 (0.2%) 0/542 (0%)
    Acute respiratory failure 0/526 (0%) 2/542 (0.4%)
    Apnoea 0/526 (0%) 1/542 (0.2%)
    Asphyxia 1/526 (0.2%) 0/542 (0%)
    Aspiration 0/526 (0%) 1/542 (0.2%)
    Bronchospasm 0/526 (0%) 1/542 (0.2%)
    Chronic obstructive pulmonary disease 1/526 (0.2%) 0/542 (0%)
    Dyspnoea 4/526 (0.8%) 4/542 (0.7%)
    Epistaxis 2/526 (0.4%) 0/542 (0%)
    Haemoptysis 3/526 (0.6%) 1/542 (0.2%)
    Hiccups 0/526 (0%) 1/542 (0.2%)
    Interstitial lung disease 0/526 (0%) 1/542 (0.2%)
    Lung disorder 1/526 (0.2%) 1/542 (0.2%)
    Pharyngeal haemorrhage 1/526 (0.2%) 0/542 (0%)
    Pleural effusion 2/526 (0.4%) 1/542 (0.2%)
    Pneumomediastinum 1/526 (0.2%) 0/542 (0%)
    Pneumonia aspiration 1/526 (0.2%) 0/542 (0%)
    Pneumothorax 2/526 (0.4%) 1/542 (0.2%)
    Pulmonary alveolar haemorrhage 0/526 (0%) 1/542 (0.2%)
    Pulmonary congestion 0/526 (0%) 1/542 (0.2%)
    Pulmonary embolism 1/526 (0.2%) 2/542 (0.4%)
    Respiratory failure 1/526 (0.2%) 1/542 (0.2%)
    Respiratory tract haemorrhage 1/526 (0.2%) 0/542 (0%)
    Upper respiratory tract inflammation 1/526 (0.2%) 0/542 (0%)
    Skin and subcutaneous tissue disorders
    Drug eruption 0/526 (0%) 1/542 (0.2%)
    Hyperhidrosis 1/526 (0.2%) 0/542 (0%)
    Neuropathic ulcer 1/526 (0.2%) 0/542 (0%)
    Palmar-plantar erythrodysaesthesia syndrome 6/526 (1.1%) 3/542 (0.6%)
    Rash 0/526 (0%) 2/542 (0.4%)
    Skin exfoliation 1/526 (0.2%) 0/542 (0%)
    Skin ulcer 0/526 (0%) 2/542 (0.4%)
    Toxic skin eruption 0/526 (0%) 1/542 (0.2%)
    Vascular disorders
    Bleeding varicose vein 1/526 (0.2%) 0/542 (0%)
    Deep vein thrombosis 1/526 (0.2%) 0/542 (0%)
    Haemorrhage 1/526 (0.2%) 2/542 (0.4%)
    Hypertension 1/526 (0.2%) 0/542 (0%)
    Hypertensive crisis 1/526 (0.2%) 0/542 (0%)
    Inferior vena caval occlusion 1/526 (0.2%) 0/542 (0%)
    Intra-abdominal haemorrhage 1/526 (0.2%) 0/542 (0%)
    Peripheral ischaemia 1/526 (0.2%) 0/542 (0%)
    Phlebitis 0/526 (0%) 1/542 (0.2%)
    Other (Not Including Serious) Adverse Events
    Sunitinib Sorafenib
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 515/526 (97.9%) 531/542 (98%)
    Blood and lymphatic system disorders
    Anaemia 79/526 (15%) 47/542 (8.7%)
    Leukopenia 96/526 (18.3%) 37/542 (6.8%)
    Neutropenia 119/526 (22.6%) 19/542 (3.5%)
    Thrombocytopenia 170/526 (32.3%) 69/542 (12.7%)
    Endocrine disorders
    Hypothyroidism 30/526 (5.7%) 7/542 (1.3%)
    Gastrointestinal disorders
    Abdominal distension 90/526 (17.1%) 56/542 (10.3%)
    Abdominal pain 121/526 (23%) 105/542 (19.4%)
    Abdominal pain upper 74/526 (14.1%) 78/542 (14.4%)
    Ascites 76/526 (14.4%) 64/542 (11.8%)
    Constipation 90/526 (17.1%) 81/542 (14.9%)
    Diarrhoea 248/526 (47.1%) 254/542 (46.9%)
    Dyspepsia 53/526 (10.1%) 39/542 (7.2%)
    Mouth ulceration 28/526 (5.3%) 18/542 (3.3%)
    Nausea 129/526 (24.5%) 93/542 (17.2%)
    Stomatitis 87/526 (16.5%) 53/542 (9.8%)
    Vomiting 103/526 (19.6%) 61/542 (11.3%)
    General disorders
    Asthenia 78/526 (14.8%) 60/542 (11.1%)
    Chest pain 21/526 (4%) 30/542 (5.5%)
    Face oedema 35/526 (6.7%) 5/542 (0.9%)
    Fatigue 171/526 (32.5%) 115/542 (21.2%)
    Mucosal inflammation 65/526 (12.4%) 39/542 (7.2%)
    Oedema 46/526 (8.7%) 23/542 (4.2%)
    Oedema peripheral 71/526 (13.5%) 46/542 (8.5%)
    Pain 25/526 (4.8%) 29/542 (5.4%)
    Pyrexia 105/526 (20%) 101/542 (18.6%)
    Hepatobiliary disorders
    Hyperbilirubinaemia 59/526 (11.2%) 43/542 (7.9%)
    Investigations
    Alanine aminotransferase increased 60/526 (11.4%) 70/542 (12.9%)
    Aspartate aminotransferase increased 84/526 (16%) 92/542 (17%)
    Blood bilirubin increased 30/526 (5.7%) 30/542 (5.5%)
    Gamma-glutamyltransferase increased 17/526 (3.2%) 28/542 (5.2%)
    Neutrophil count decreased 50/526 (9.5%) 4/542 (0.7%)
    Platelet count 29/526 (5.5%) 9/542 (1.7%)
    Platelet count decreased 65/526 (12.4%) 16/542 (3%)
    Weight decreased 44/526 (8.4%) 115/542 (21.2%)
    White blood cell count decreased 45/526 (8.6%) 5/542 (0.9%)
    Metabolism and nutrition disorders
    Decreased appetite 233/526 (44.3%) 187/542 (34.5%)
    Hypoalbuminaemia 47/526 (8.9%) 42/542 (7.7%)
    Musculoskeletal and connective tissue disorders
    Back pain 46/526 (8.7%) 40/542 (7.4%)
    Pain in extremity 14/526 (2.7%) 27/542 (5%)
    Nervous system disorders
    Dizziness 48/526 (9.1%) 17/542 (3.1%)
    Dysgeusia 69/526 (13.1%) 15/542 (2.8%)
    Headache 43/526 (8.2%) 40/542 (7.4%)
    Psychiatric disorders
    Insomnia 60/526 (11.4%) 54/542 (10%)
    Renal and urinary disorders
    Proteinuria 44/526 (8.4%) 38/542 (7%)
    Respiratory, thoracic and mediastinal disorders
    Cough 77/526 (14.6%) 62/542 (11.4%)
    Dysphonia 10/526 (1.9%) 49/542 (9%)
    Dyspnoea 53/526 (10.1%) 32/542 (5.9%)
    Epistaxis 63/526 (12%) 25/542 (4.6%)
    Oropharyngeal pain 30/526 (5.7%) 19/542 (3.5%)
    Skin and subcutaneous tissue disorders
    Alopecia 19/526 (3.6%) 154/542 (28.4%)
    Palmar-plantar erythrodysaesthesia syndrome 232/526 (44.1%) 330/542 (60.9%)
    Pruritus 34/526 (6.5%) 58/542 (10.7%)
    Rash 108/526 (20.5%) 147/542 (27.1%)
    Yellow skin 37/526 (7%) 0/542 (0%)
    Vascular disorders
    Hypertension 109/526 (20.7%) 95/542 (17.5%)

    Limitations/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.

    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

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer, Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00699374
    Other Study ID Numbers:
    • A6181170
    First Posted:
    Jun 18, 2008
    Last Update Posted:
    Jan 14, 2013
    Last Verified:
    Dec 1, 2012