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Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer

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ClinicalTrials.gov Identifier: NCT00678392
Recruitment Status : Completed
First Posted : May 15, 2008
Results First Posted : March 27, 2012
Last Update Posted : January 9, 2019
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 Kidney Neoplasms
Interventions Drug: Axitinib (AG-013736)
Drug: Sorafenib
Enrollment 723
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Axitinib 5 mg Sorafenib 400 mg
Hide Arm/Group Description Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks. Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Period Title: Overall Study
Started 361 362
Treated 359 355
Completed 0 0
Not Completed 361 362
Reason Not Completed
Adverse Event             0             6
Death             280             269
Lost to Follow-up             15             13
Objective Progression or Relapse             3             8
Sponsor's Decision             1             2
Withdrawal by Subject             4             4
Randomized But Not Treated             2             7
Other             56             53
Arm/Group Title Axitinib 5 mg Sorafenib 400 mg Total
Hide Arm/Group Description Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks. Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 361 362 723
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or receive a different drug from that to which they were randomized.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 361 participants 362 participants 723 participants
Less than (<) 65 years 238 238 476
Greater than or equal to (>=) 65 years 123 124 247
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 361 participants 362 participants 723 participants
Female
96
  26.6%
104
  28.7%
200
  27.7%
Male
265
  73.4%
258
  71.3%
523
  72.3%
1.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as the time in months from start of study treatment to the first documentation of objective tumor progression of disease (PD) or to death due to any cause, whichever occurs first. PD was assessed by response evaluation criteria in solid tumors (RECIST) version 1.0. PD: >=20 percent (%) increase in the sum of the longest dimensions (LD) of the target lesions taking as a reference the smallest sum of the LD recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Occurrence of a pleural effusion or ascites was also considered PD if demonstrated by cytological investigation and it was not previously documented. New bone lesions not previously documented were considered PD if confirmed by computed tomography/magnetic resonance imaging or X-ray.
Time Frame From initiation of treatment up to follow-up period (up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
Arm/Group Title Axitinib 5 mg Sorafenib 400 mg
Hide Arm/Group Description:
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Overall Number of Participants Analyzed 361 362
Median (95% Confidence Interval)
Unit of Measure: Months
6.7
(6.3 to 8.6)
4.7
(4.6 to 5.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Axitinib 5 mg, Sorafenib 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was obtained from 1-sided log rank test, stratified by eastern cooperative oncology group (ECOG) and prior treatment. One-sided log-rank test at 0.025 level of significance was used to compare PFS between the 2 treatment arms.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.665
Confidence Interval (2-Sided) 95%
0.544 to 0.812
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the duration from start of study treatment to date of death due to any cause. OS was calculated as (months) = (date of death minus the date of first dose of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive.
Time Frame From initiation of treatment up to follow-up period (up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
Arm/Group Title Axitinib 5 mg Sorafenib 400 mg
Hide Arm/Group Description:
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Overall Number of Participants Analyzed 361 362
Median (95% Confidence Interval)
Unit of Measure: Months
20.1
(16.7 to 23.4)
19.2
(17.5 to 22.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Axitinib 5 mg, Sorafenib 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3744
Comments [Not Specified]
Method Log Rank
Comments P-value was obtained from a 1-sided log-rank test of treatment stratified by ECOG performance status and prior treatment.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.969
Confidence Interval (2-Sided) 95%
0.800 to 1.174
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR = percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0 recorded from first dose of study treatment until PD or death due to any cause. CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks. PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions. PD: >=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray.
Time Frame From initiation of treatment up to follow-up period (up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
Arm/Group Title Axitinib 5 mg Sorafenib 400 mg
Hide Arm/Group Description:
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Overall Number of Participants Analyzed 361 362
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
19.4
(15.4 to 23.9)
9.4
(6.6 to 12.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Axitinib 5 mg, Sorafenib 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value was obtained from a 1-sided Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status and prior treatment.
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 2.056
Confidence Interval (2-Sided) 95%
1.408 to 3.003
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Duration of Response (DR)
Hide Description DR: time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.0, a) CR: disappearance of all target, non target lesions and no appearance of new lesions, documented on 2 occasions separated by at least 4 weeks, b) PR: at least 30 % decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non target lesions, no appearance of new lesions, c) PD: >=20% increase in sum of LD of the target lesions taking as a reference smallest sum of LD recorded since the start of treatment or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Occurrence of pleural effusion or ascites if demonstrated by cytological investigation, not previously documented. New bone lesions not previously documented if confirmed by computed tomography/magnetic resonance imaging or X-ray.
Time Frame From initiation of treatment up to follow-up period (up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
Arm/Group Title Axitinib 5 mg Sorafenib 400 mg
Hide Arm/Group Description:
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Overall Number of Participants Analyzed 361 362
Median (95% Confidence Interval)
Unit of Measure: Months
11.0 [1] 
(7.4 to NA)
10.6
(8.8 to 11.5)
[1]
The upper limit of 95 percent confidence interval was not reached at the time of data cut-off.
5.Secondary Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life­ threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non­serious AEs.
Time Frame From initiation of treatment up to follow-up period (up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Arm/Group Title Axitinib 5 mg Sorafenib 400 mg
Hide Arm/Group Description:
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Overall Number of Participants Analyzed 359 355
Measure Type: Number
Unit of Measure: Percentage of participants
AEs 96.1 98.0
SAEs 40.7 35.8
6.Secondary Outcome
Title Percentage of Participants With Adverse Events (AEs) by Severity
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE.
Time Frame From initiation of treatment up to follow-up period (up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Arm/Group Title Axitinib 5 mg Sorafenib 400 mg
Hide Arm/Group Description:
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Overall Number of Participants Analyzed 359 355
Measure Type: Number
Unit of Measure: Percentage of participants
Grade 1 3.9 3.1
Grade 2 20.1 21.7
Grade 3 47.6 52.4
Grade 4 10.6 11.5
Grade 5 13.9 9.3
7.Secondary Outcome
Title Percentage of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life ­threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non ­serious AEs.
Time Frame From initiation of treatment up to follow-up period (up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.
Arm/Group Title Axitinib 5 mg Sorafenib 400 mg
Hide Arm/Group Description:
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Overall Number of Participants Analyzed 359 355
Measure Type: Number
Unit of Measure: Percentage of participants
AEs 92.2 95.2
SAEs 15.3 13.8
8.Secondary Outcome
Title Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Hide Description Hematology laboratory test included hemoglobin, platelet count, white blood cells count, neutrophils and lymphocytes. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.
Time Frame From initiation of treatment up to follow-up period (up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "n" signifies number of participants available for specified categories for each arm respectively.
Arm/Group Title Axitinib 5 mg Sorafenib 400 mg
Hide Arm/Group Description:
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Overall Number of Participants Analyzed 359 355
Measure Type: Number
Unit of Measure: Participants
Hemoglobin: Grade 1 (n =320, 316) 93 112
Hemoglobin: Grade 2 (n =320, 316) 19 41
Hemoglobin: Grade 3 (n =320, 316) 1 11
Hemoglobin: Grade 4 (n =320, 316) 0 1
Lymphocytes: Grade 1 (n =317, 309) 7 7
Lymphocytes: Grade 2 (n =317, 309) 89 93
Lymphocytes: Grade 3 (n =317, 309) 10 11
Lymphocytes: Grade 4 (n =317, 309) 0 0
Neutrophils: Grade 1 (n =316, 308) 13 20
Neutrophils: Grade 2 (n =316, 308) 4 4
Neutrophils: Grade 3 (n =316, 308) 2 2
Neutrophils: Grade 4 (n =316, 308) 0 0
Platelets: Grade 1 (n =312, 310) 47 41
Platelets: Grade 2 (n =312, 310) 0 3
Platelets: Grade 3 (n =312, 310) 1 0
Platelets: Grade 4 (n =312, 310) 0 0
White Blood Cells: Grade 1 (n =320, 315) 32 36
White Blood Cells: Grade 2 (n =320, 315) 4 12
White Blood Cells: Grade 3 (n =320, 315) 0 1
White Blood Cells: Grade 4 (n =320, 315) 0 0
9.Secondary Outcome
Title Number of Participants With Clinically Significant Laboratory Abnormalities: Biochemistry
Hide Description Biochemistry laboratory test included parameters: alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bicarbonate, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, hypophosphatemia and lipase. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.
Time Frame From initiation of treatment up to follow-up period (up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "n" signifies number of participants available for specified categories for each arm respectively.
Arm/Group Title Axitinib 5 mg Sorafenib 400 mg
Hide Arm/Group Description:
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Overall Number of Participants Analyzed 359 355
Measure Type: Number
Unit of Measure: Participants
Alanine aminotransferase: Grade 1 (n =331, 313) 65 57
Alanine aminotransferase: Grade 2 (n =331, 313) 8 6
Alanine aminotransferase: Grade 3 (n =331, 313) 1 2
Alanine aminotransferase: Grade 4 (n =331, 313) 0 3
Alkaline phosphatase: Grade 1 (n =336, 319) 88 92
Alkaline phosphatase: Grade 2 (n =336, 319) 8 15
Alkaline phosphatase: Grade 3 (n =336, 319) 4 3
Alkaline phosphatase: Grade 4 (n =336, 319) 0 0
Amylase: Grade 1 (n =338, 319) 64 76
Amylase: Grade 2 (n =338, 319) 12 21
Amylase: Grade 3 (n =338, 319) 7 6
Amylase: Grade 4 (n =338, 319) 0 1
Aspartate aminotransferase: Grade 1 (n =331, 311) 59 67
Aspartate aminotransferase: Grade 2 (n =331, 311) 5 7
Aspartate aminotransferase: Grade 3 (n =331, 311) 1 4
Aspartate aminotransferase: Grade 4 (n =331, 311) 0 0
Bicarbonate: Grade 1 (n =314, 291) 127 115
Bicarbonate: Grade 2 (n =314, 291) 11 10
Bicarbonate: Grade 3 (n =314, 291) 0 0
Bicarbonate: Grade 4 (n =314, 291) 1 0
Bilirubin: Grade 1 (n =336, 318) 16 12
Bilirubin: Grade 2 (n =336, 318) 8 2
Bilirubin: Grade 3 (n =336, 318) 1 1
Bilirubin: Grade 4 (n =336, 318) 0 0
Creatinine: Grade 1 (n =336, 318) 155 121
Creatinine: Grade 2 (n =336, 318) 30 9
Creatinine: Grade 3 (n =336, 318) 0 1
Creatinine: Grade 4 (n =336, 318) 0 0
Hypercalcemia: Grade 1 (n =336, 319) 92 22
Hypercalcemia: Grade 2 (n =336, 319) 8 1
Hypercalcemia: Grade 3 (n =336, 319) 1 0
Hypercalcemia: Grade 4 (n =336, 319) 0 0
Hyperglycemia: Grade 1 (n =336, 319) 41 28
Hyperglycemia: Grade 2 (n =336, 319) 45 37
Hyperglycemia: Grade 3 (n =336, 319) 7 7
Hyperglycemia: Grade 4 (n =336, 319) 0 0
Hyperkalemia: Grade 1 (n =333, 314) 0 0
Hyperkalemia: Grade 2 (n =333, 314) 42 22
Hyperkalemia: Grade 3 (n =333, 314) 9 8
Hyperkalemia: Grade 4 (n =333, 314) 0 0
Hypernatremia: Grade 1 (n =338, 319) 34 23
Hypernatremia: Grade 2 (n =338, 319) 19 14
Hypernatremia: Grade 3 (n =338, 319) 3 1
Hypernatremia: Grade 4 (n =338, 319) 0 2
Hypoalbuminemia: Grade 1 (n =337, 319) 37 25
Hypoalbuminemia: Grade 2 (n =337, 319) 11 31
Hypoalbuminemia: Grade 3 (n =337, 319) 1 2
Hypoalbuminemia: Grade 4 (n =337, 319) 0 0
Hypocalcemia: Grade 1 (n =336, 319) 25 67
Hypocalcemia: Grade 2 (n =336, 319) 4 18
Hypocalcemia: Grade 3 (n =336, 319) 2 2
Hypocalcemia: Grade 4 (n =336, 319) 1 2
Hypoglycemia: Grade 1 (n =336, 319) 23 9
Hypoglycemia: Grade 2 (n =336, 319) 12 16
Hypoglycemia: Grade 3 (n =336, 319) 1 1
Hypoglycemia: Grade 4 (n =336, 319) 0 0
Hypokalemia: Grade 1 (n =333, 314) 22 21
Hypokalemia: Grade 2 (n =333, 314) 0 0
Hypokalemia: Grade 3 (n =333, 314) 0 5
Hypokalemia: Grade 4 (n =333, 314) 0 0
Hyponatremia: Grade 1 (n =338, 319) 33 27
Hyponatremia: Grade 2 (n =338, 319) 0 0
Hyponatremia: Grade 3 (n =338, 319) 11 6
Hyponatremia: Grade 4 (n =338, 319) 1 1
Hypophosphatemia: Grade 1 (n =336, 318) 4 8
Hypophosphatemia: Grade 2 (n =336, 318) 33 99
Hypophosphatemia: Grade 3 (n =336, 318) 6 51
Hypophosphatemia: Grade 4 (n =336, 318) 0 0
Lipase: Grade 1 (n =338, 319) 53 76
Lipase: Grade 2 (n =338, 319) 22 25
Lipase: Grade 3 (n =338, 319) 14 40
Lipase: Grade 4 (n =338, 319) 2 7
10.Secondary Outcome
Title Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
Hide Description Urinalysis included urine blood/ hemoglobin, glucose and protein. Abnormalities were assessed by CTCAE Grade Version 2 for severity: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.
Time Frame From initiation of treatment up to follow-up period (up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "n" signifies number of participants available for specified categories for each arm respectively.
Arm/Group Title Axitinib 5 mg Sorafenib 400 mg
Hide Arm/Group Description:
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Overall Number of Participants Analyzed 359 355
Measure Type: Number
Unit of Measure: Participants
Urine blood/ hemoglobin: Grade 1 (n =304, 272) 45 35
Urine blood/ hemoglobin: Grade 2 (n =304, 272) 1 0
Urine blood/ hemoglobin: Grade 3 (n =304, 272) 0 0
Urine blood/ hemoglobin: Grade 4 (n =304, 272) 0 0
Urine glucose: Grade 1 (n =322, 286) 12 13
Urine glucose: Grade 2 (n =322, 286) 0 3
Urine glucose: Grade 3 (n =322, 286) 0 0
Urine glucose: Grade 4 (n =322, 286) 1 1
Urine protein: Grade 1 (n =326, 289) 105 91
Urine protein: Grade 2 (n =326, 289) 31 27
Urine protein: Grade 3 (n =326, 289) 27 21
Urine protein: Grade 4 (n =326, 289) 9 7
11.Secondary Outcome
Title Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15) Score
Hide Description FKSI was used to assess quality of life (QoL) for those diagnosed with renal cell cancer and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher scores indicate greater presence of symptoms.
Time Frame Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, "n" signifies those participants who were evaluable for the specified time points.
Arm/Group Title Axitinib 5 mg Sorafenib 400 mg
Hide Arm/Group Description:
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Overall Number of Participants Analyzed 361 362
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n =346, 342) 43.199  (8.416) 43.339  (8.162)
Cycle 2/Day1 (n =319, 296) 42.351  (8.305) 41.668  (7.696)
Cycle 3/Day1 (n =279, 246) 42.590  (7.729) 42.424  (7.888)
Cycle 4/Day1 (n =257, 221) 42.791  (8.180) 43.424  (7.345)
Cycle 5/Day1 (n =238, 203) 42.968  (8.152) 42.907  (7.255)
Cycle 6/Day1 (n =213, 179) 42.949  (7.842) 43.057  (7.724)
Cycle 7/Day1 (n =206, 158) 42.747  (7.621) 43.578  (7.621)
Cycle 8/Day1 (n =177, 136) 43.580  (7.578) 44.074  (7.757)
Cycle 9/Day1 (n =163, 118) 43.191  (8.300) 44.518  (6.511)
Cycle 10/Day1 (n =146, 96) 43.312  (8.564) 44.771  (7.155)
Cycle 11/Day1 (n =122, 85) 44.119  (8.306) 44.438  (7.388)
Cycle 12/Day1 (n =110, 70) 44.517  (8.212) 44.357  (7.247)
Cycle 13/Day1 (n =92, 58) 44.492  (7.972) 45.261  (7.840)
Cycle 14/Day1 (n =81, 54) 44.485  (8.204) 44.898  (7.495)
Cycle 15/Day1 (n =61, 38) 45.291  (7.095) 45.053  (6.682)
Cycle 16/Day1 (n =52, 34) 45.217  (7.656) 44.445  (7.160)
Cycle 17/Day1 (n =47, 28) 45.242  (7.344) 44.438  (7.683)
Cycle 18/Day1 (n =36, 22) 44.861  (7.769) 44.182  (7.228)
Cycle 19/Day1 (n =29, 14) 45.379  (6.662) 45.026  (7.705)
Cycle 20/Day1 (n =20, 12) 47.050  (5.375) 44.780  (6.689)
Cycle 21/Day1 (n =15, 7) 45.850  (5.209) 44.494  (6.153)
End of treatment (n=163, 191) 38.328  (9.472) 38.457  (8.787)
Follow up (n =80, 110) 41.919  (8.318) 40.028  (9.048)
12.Secondary Outcome
Title Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Score
Hide Description FKSI-DRS was used to assess quality of life for those diagnosed with renal cell cancer and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert-type scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptoms) to 36 (very much); higher scores indicate greater presence of symptoms.
Time Frame Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, "n" signifies those participants who were evaluable for the specified time points.
Arm/Group Title Axitinib 5 mg Sorafenib 400 mg
Hide Arm/Group Description:
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Overall Number of Participants Analyzed 361 362
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n =346, 341) 28.874  (5.187) 28.975  (5.193)
Cycle 2/Day1 (n =319, 295) 28.211  (4.920) 28.399  (5.064)
Cycle 3/Day1 (n =279, 244) 28.640  (4.837) 28.640  (4.868)
Cycle 4/Day1 (n =257, 220) 28.822  (4.952) 29.130  (4.322)
Cycle 5/Day1 (n =238, 202) 28.869  (4.880) 29.007  (4.379)
Cycle 6/Day1 (n =213, 178) 29.159  (4.462) 29.098  (4.697)
Cycle 7/Day1 (n =206, 157) 29.042  (4.581) 29.361  (4.558)
Cycle 8/Day1 (n =177, 135) 29.520  (4.346) 29.619  (4.386)
Cycle 9/Day1 (n =163, 117) 29.194  (4.937) 29.884  (3.838)
Cycle 10/Day1 (n =146, 96) 29.343  (4.907) 29.604  (3.959)
Cycle 11/Day1 (n =122, 85) 29.762  (4.943) 29.366  (4.404)
Cycle 12/Day1 (n =110, 70) 29.764  (4.507) 29.257  (4.299)
Cycle 13/Day1 (n =92, 58) 29.594  (4.205) 29.666  (4.710)
Cycle 14/Day1 (n =81, 54) 29.711  (4.313) 29.820  (4.333)
Cycle 15/Day1 (n =61, 38) 30.324  (3.582) 29.500  (3.454)
Cycle 16/Day1 (n =52, 34) 30.430  (3.443) 29.474  (4.146)
Cycle 17/Day1 (n =47, 28) 30.551  (3.331) 28.737  (4.930)
Cycle 18/Day1 (n =36, 22) 30.194  (3.992) 29.045  (4.520)
Cycle 19/Day1 (n =29, 14) 30.130  (3.636) 29.286  (4.795)
Cycle 20/Day1 (n =20, 12) 31.300  (2.736) 29.250  (4.025)
Cycle 21/Day1 (n =15, 7) 31.067  (3.173) 30.143  (4.100)
End of Treatment (n =163, 191) 26.288  (5.806) 26.517  (5.614)
Follow up (n =80, 110) 28.263  (4.802) 27.516  (5.577)
13.Secondary Outcome
Title Euro Quality of Life Questionnaire- 5 Dimension (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 or index score. Health state profile component assesses level of health for 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain was rated on a 3-point response scale (1= no problems, 2= some/moderate problems and 3= extreme problems). Scoring formula developed by EuroQol Group assigned a utility value for each domain in the profile. Score were transformed and resulted in a total score range of 0 to 1, with higher scores indicating better health.
Time Frame Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, "n" signifies those participants who were evaluable for the specified time points.
Arm/Group Title Axitinib 5 mg Sorafenib 400 mg
Hide Arm/Group Description:
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Overall Number of Participants Analyzed 361 362
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n =347, 341) 0.732  (0.275) 0.731  (0.257)
Cycle 2/Day1 (n =326, 307) 0.716  (0.267) 0.696  (0.237)
Cycle 3/Day1 (n =287, 248) 0.722  (0.243) 0.709  (0.239)
Cycle 4/Day1 (n =262, 226) 0.730  (0.236) 0.716  (0.248)
Cycle 5/Day1 (n =244, 207) 0.730  (0.237) 0.711  (0.243)
Cycle 6/Day1 (n =221, 178) 0.734  (0.230) 0.704  (0.246)
Cycle 7/Day1 (n =213, 163) 0.718  (0.267) 0.728  (0.228)
Cycle 8/Day1 (n =181, 136) 0.756  (0.236) 0.702  (0.259)
Cycle 9/Day1 (n =169, 120) 0.760  (0.227) 0.730  (0.229)
Cycle 10/Day1 (n =151, 98) 0.734  (0.243) 0.730  (0.233)
Cycle 11/Day1 (n =126, 87) 0.764  (0.235) 0.724  (0.250)
Cycle 12/Day1 (n =110, 73) 0.744  (0.244) 0.734  (0.232)
Cycle 13/Day1 (n =96, 61) 0.760  (0.211) 0.753  (0.232)
Cycle 14/Day1 (n =80, 57) 0.723  (0.239) 0.752  (0.211)
Cycle 15/Day1 (n =63, 41) 0.730  (0.255) 0.758  (0.191)
Cycle 16/Day1 (n =54, 37) 0.749  (0.220) 0.785  (0.158)
Cycle 17/Day1 (n =48, 29) 0.779  (0.186) 0.764  (0.193)
Cycle 18/Day1 (n =37, 20) 0.755  (0.204) 0.755  (0.208)
Cycle 19/Day1 (n =29, 14) 0.734  (0.253) 0.804  (0.184)
Cycle 20/Day1 (n =21, 12) 0.794  (0.220) 0.771  (0.182)
Cycle 21/Day1 (n =16, 7) 0.700  (0.273) 0.771  (0.182)
End of Treatment (n =169, 196) 0.608  (0.316) 0.612  (0.310)
Follow up (n =76, 106) 0.682  (0.294) 0.666  (0.295)
14.Secondary Outcome
Title Euro Quality of Life Questionnaire- 5 Dimension (EQ-5D): Visual Analog Scale (VAS)
Hide Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. VAS component: participants rated their current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health.
Time Frame Baseline (Predose on Cycle 1 Day 1) , Day 1 of each cycle until Cycle 21, End of treatment (Day 670) and Follow-up visit (Day 698)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized. Here, "n" signifies those participants who were evaluable for the specified time points.
Arm/Group Title Axitinib 5 mg Sorafenib 400 mg
Hide Arm/Group Description:
Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks.
Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
Overall Number of Participants Analyzed 361 362
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n =341, 339) 70.560  (19.187) 70.351  (17.403)
Cycle 2/Day1 (n =317, 302) 69.003  (20.195) 67.606  (18.265)
Cycle 3/Day1 (n =280, 250) 69.843  (17.927) 69.712  (18.429)
Cycle 4/Day1 (n =261, 224) 69.180  (18.636) 70.759  (17.189)
Cycle 5/Day1 (n =244, 205) 69.705  (18.330) 71.888  (16.999)
Cycle 6/Day1 (n =220, 178) 69.900  (18.168) 71.365  (17.019)
Cycle 7/Day1 (n =209, 163) 69.919  (18.063) 72.282  (17.521)
Cycle 8/Day1 (n =180, 139) 70.756  (19.183) 71.475  (18.523)
Cycle 9/Day1 (n =168, 121) 70.667  (18.556) 73.380  (17.473)
Cycle 10/Day1 (n =151, 98) 70.629  (18.680) 75.102  (14.854)
Cycle 11/Day1 (n =126, 87) 72.103  (18.064) 74.586  (15.161)
Cycle 12/Day1 (n =111, 73) 71.730  (17.276) 73.959  (15.852)
Cycle 13/Day1 (n =94, 61) 70.723  (19.147) 75.693  (14.571)
Cycle 14/Day1 (n =81, 58) 69.420  (20.286) 75.362  (15.875)
Cycle 15/Day1 (n =62, 42) 73.016  (15.325) 75.357  (15.368)
Cycle 16/Day1 (n =52, 37) 70.269  (19.272) 73.676  (15.699)
Cycle 17/Day1 (n =48, 30) 71.375  (17.840) 73.767  (16.298)
Cycle 18/Day1 (n =37, 23) 70.459  (18.853) 73.870  (16.904)
Cycle 19/Day1 (n =29, 14) 71.034  (16.963) 70.571  (17.956)
Cycle 20/Day1 (n =21, 12) 73.143  (15.347) 66.917  (17.758)
Cycle 21/Day1 (n =16, 7) 74.563  (16.054) 64.714  (16.183)
End of Treatment (n =166, 197) 61.759  (21.668) 61.690  (20.973)
Follow up (n =76, 109) 64.382  (21.392) 66.037  (19.754)
Time Frame From initiation of treatment up to follow-up period (up to 3 years)
Adverse Event Reporting Description Same event may appear as both AE and SAE, what is presented are distinct event. Event may be classified as serious in 1 participant, nonserious in other, or 1 participant may have experienced both serious, nonserious event during study.
 
Arm/Group Title Axitinib 5 mg Sorafenib 400 mg
Hide Arm/Group Description Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily in cycles of 4 weeks. Sorafenib 400 mg tablet administered orally twice daily in cycles of 4 weeks.
All-Cause Mortality
Axitinib 5 mg Sorafenib 400 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Axitinib 5 mg Sorafenib 400 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   146/359 (40.67%)   127/355 (35.77%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/359 (0.00%)  8/355 (2.25%) 
Splenic infarction * 1  0/359 (0.00%)  1/355 (0.28%) 
Cardiac disorders     
Acute coronary syndrome * 1  0/359 (0.00%)  2/355 (0.56%) 
Acute myocardial infarction * 1  2/359 (0.56%)  0/355 (0.00%) 
Angina pectoris * 1  0/359 (0.00%)  2/355 (0.56%) 
Arrhythmia supraventricular * 1  1/359 (0.28%)  0/355 (0.00%) 
Arteriosclerosis coronary artery * 1  1/359 (0.28%)  0/355 (0.00%) 
Atrial fibrillation * 1  2/359 (0.56%)  0/355 (0.00%) 
Atrial flutter * 1  1/359 (0.28%)  0/355 (0.00%) 
Atrioventricular block * 1  0/359 (0.00%)  1/355 (0.28%) 
Bradycardia * 1  1/359 (0.28%)  0/355 (0.00%) 
Cardiac arrest * 1  1/359 (0.28%)  0/355 (0.00%) 
Cardiac failure * 1  2/359 (0.56%)  1/355 (0.28%) 
Cardiopulmonary failure * 1  2/359 (0.56%)  1/355 (0.28%) 
Congestive cardiomyopathy * 1  0/359 (0.00%)  1/355 (0.28%) 
Coronary artery insufficiency * 1  1/359 (0.28%)  0/355 (0.00%) 
Haemorrhage coronary artery * 1  1/359 (0.28%)  0/355 (0.00%) 
Mitral valve incompetence * 1  1/359 (0.28%)  0/355 (0.00%) 
Myocardial infarction * 1  6/359 (1.67%)  4/355 (1.13%) 
Myocardial ischaemia * 1  1/359 (0.28%)  0/355 (0.00%) 
Prinzmetal angina * 1  1/359 (0.28%)  0/355 (0.00%) 
Supraventricular tachycardia * 1  1/359 (0.28%)  0/355 (0.00%) 
Tachycardia * 1  0/359 (0.00%)  1/355 (0.28%) 
Endocrine disorders     
Adrenal insufficiency * 1  0/359 (0.00%)  1/355 (0.28%) 
Hypothyroidism * 1  1/359 (0.28%)  0/355 (0.00%) 
Secondary hypothyroidism * 1  1/359 (0.28%)  0/355 (0.00%) 
Thyroiditis * 1  0/359 (0.00%)  1/355 (0.28%) 
Eye disorders     
Diplopia * 1  1/359 (0.28%)  0/355 (0.00%) 
Retinal artery embolism * 1  0/359 (0.00%)  1/355 (0.28%) 
Retinal artery occlusion * 1  1/359 (0.28%)  0/355 (0.00%) 
Retinal vein occlusion * 1  1/359 (0.28%)  0/355 (0.00%) 
Retinal vein thrombosis * 1  1/359 (0.28%)  0/355 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/359 (0.28%)  2/355 (0.56%) 
Anal fistula * 1  1/359 (0.28%)  0/355 (0.00%) 
Ascites * 1  0/359 (0.00%)  1/355 (0.28%) 
Colitis ulcerative * 1  0/359 (0.00%)  1/355 (0.28%) 
Constipation * 1  2/359 (0.56%)  1/355 (0.28%) 
Diarrhoea * 1  8/359 (2.23%)  5/355 (1.41%) 
Duodenal ulcer haemorrhage * 1  0/359 (0.00%)  1/355 (0.28%) 
Enterocolitis * 1  0/359 (0.00%)  1/355 (0.28%) 
Gastric haemorrhage * 1  2/359 (0.56%)  0/355 (0.00%) 
Gastric ulcer * 1  1/359 (0.28%)  0/355 (0.00%) 
Gastritis * 1  0/359 (0.00%)  1/355 (0.28%) 
Gastrointestinal haemorrhage * 1  0/359 (0.00%)  5/355 (1.41%) 
Gastrointestinal perforation * 1  1/359 (0.28%)  0/355 (0.00%) 
Haematemesis * 1  0/359 (0.00%)  1/355 (0.28%) 
Inguinal hernia * 1  3/359 (0.84%)  0/355 (0.00%) 
Intestinal obstruction * 1  4/359 (1.11%)  1/355 (0.28%) 
Lower gastrointestinal haemorrhage * 1  1/359 (0.28%)  1/355 (0.28%) 
Melaena * 1  1/359 (0.28%)  0/355 (0.00%) 
Nausea * 1  1/359 (0.28%)  1/355 (0.28%) 
Pancreatitis * 1  0/359 (0.00%)  1/355 (0.28%) 
Rectal haemorrhage * 1  0/359 (0.00%)  1/355 (0.28%) 
Retroperitoneal haemorrhage * 1  0/359 (0.00%)  1/355 (0.28%) 
Small intestinal obstruction * 1  1/359 (0.28%)  0/355 (0.00%) 
Subileus * 1  0/359 (0.00%)  1/355 (0.28%) 
Upper gastrointestinal haemorrhage * 1  0/359 (0.00%)  1/355 (0.28%) 
Vomiting * 1  5/359 (1.39%)  2/355 (0.56%) 
General disorders     
Asthenia * 1  2/359 (0.56%)  1/355 (0.28%) 
Chest pain * 1  2/359 (0.56%)  2/355 (0.56%) 
Chills * 1  1/359 (0.28%)  0/355 (0.00%) 
Death * 1  3/359 (0.84%)  6/355 (1.69%) 
Device dislocation * 1  0/359 (0.00%)  1/355 (0.28%) 
Disease progression * 1  32/359 (8.91%)  18/355 (5.07%) 
Fatigue * 1  4/359 (1.11%)  0/355 (0.00%) 
General physical health deterioration * 1  3/359 (0.84%)  5/355 (1.41%) 
Hernia * 1  1/359 (0.28%)  0/355 (0.00%) 
Impaired healing * 1  0/359 (0.00%)  1/355 (0.28%) 
Inflammation * 1  0/359 (0.00%)  1/355 (0.28%) 
Malaise * 1  1/359 (0.28%)  0/355 (0.00%) 
Mucosal inflammation * 1  1/359 (0.28%)  0/355 (0.00%) 
Oedema * 1  1/359 (0.28%)  0/355 (0.00%) 
Pain * 1  2/359 (0.56%)  3/355 (0.85%) 
Pyrexia * 1  7/359 (1.95%)  5/355 (1.41%) 
Hepatobiliary disorders     
Biliary dilatation * 1  0/359 (0.00%)  1/355 (0.28%) 
Budd-Chiari syndrome * 1  1/359 (0.28%)  0/355 (0.00%) 
Cholangitis * 1  1/359 (0.28%)  1/355 (0.28%) 
Cholecystitis * 1  1/359 (0.28%)  1/355 (0.28%) 
Cholelithiasis * 1  0/359 (0.00%)  1/355 (0.28%) 
Hepatic function abnormal * 1  0/359 (0.00%)  1/355 (0.28%) 
Immune system disorders     
Hypersensitivity * 1  1/359 (0.28%)  0/355 (0.00%) 
Infections and infestations     
Abdominal abscess * 1  1/359 (0.28%)  0/355 (0.00%) 
Appendicitis * 1  1/359 (0.28%)  2/355 (0.56%) 
Aspergillus infection * 1  0/359 (0.00%)  1/355 (0.28%) 
Bacterial diarrhoea * 1  1/359 (0.28%)  0/355 (0.00%) 
Cellulitis * 1  0/359 (0.00%)  1/355 (0.28%) 
Diverticulitis * 1  0/359 (0.00%)  1/355 (0.28%) 
Erysipelas * 1  1/359 (0.28%)  0/355 (0.00%) 
Gastroenteritis * 1  1/359 (0.28%)  0/355 (0.00%) 
Gastroenteritis viral * 1  1/359 (0.28%)  0/355 (0.00%) 
Herpes zoster * 1  0/359 (0.00%)  1/355 (0.28%) 
Infection * 1  3/359 (0.84%)  0/355 (0.00%) 
Intervertebral discitis * 1  0/359 (0.00%)  1/355 (0.28%) 
Lower respiratory tract infection * 1  0/359 (0.00%)  4/355 (1.13%) 
Lower respiratory tract infection bacterial * 1  1/359 (0.28%)  0/355 (0.00%) 
Lung infection * 1  0/359 (0.00%)  1/355 (0.28%) 
Muscle abscess * 1  0/359 (0.00%)  1/355 (0.28%) 
Pneumonia * 1  5/359 (1.39%)  4/355 (1.13%) 
Pneumonia streptococcal * 1  1/359 (0.28%)  0/355 (0.00%) 
Pneumonia viral * 1  1/359 (0.28%)  0/355 (0.00%) 
Pulmonary tuberculosis * 1  0/359 (0.00%)  1/355 (0.28%) 
Pyelonephritis * 1  0/359 (0.00%)  1/355 (0.28%) 
Respiratory tract infection * 1  1/359 (0.28%)  1/355 (0.28%) 
Sepsis * 1  1/359 (0.28%)  2/355 (0.56%) 
Septic shock * 1  0/359 (0.00%)  1/355 (0.28%) 
Urinary tract infection * 1  2/359 (0.56%)  2/355 (0.56%) 
Injury, poisoning and procedural complications     
Fall * 1  1/359 (0.28%)  2/355 (0.56%) 
Femoral neck fracture * 1  1/359 (0.28%)  0/355 (0.00%) 
Gastrointestinal anastomotic leak * 1  1/359 (0.28%)  0/355 (0.00%) 
Humerus fracture * 1  1/359 (0.28%)  0/355 (0.00%) 
Laceration * 1  1/359 (0.28%)  0/355 (0.00%) 
Lumbar vertebral fracture * 1  2/359 (0.56%)  0/355 (0.00%) 
Procedural pain * 1  1/359 (0.28%)  0/355 (0.00%) 
Radiation pneumonitis * 1  1/359 (0.28%)  0/355 (0.00%) 
Rib fracture * 1  0/359 (0.00%)  1/355 (0.28%) 
Soft tissue injury * 1  0/359 (0.00%)  1/355 (0.28%) 
Spinal compression fracture * 1  1/359 (0.28%)  0/355 (0.00%) 
Investigations     
Neutrophil count abnormal * 1  1/359 (0.28%)  0/355 (0.00%) 
Alanine aminotransferase increased * 1  0/359 (0.00%)  1/355 (0.28%) 
Aspartate aminotransferase increased * 1  0/359 (0.00%)  1/355 (0.28%) 
Blood alkaline phosphatase increased * 1  0/359 (0.00%)  1/355 (0.28%) 
Blood creatinine increased * 1  2/359 (0.56%)  1/355 (0.28%) 
Blood lactate dehydrogenase increased * 1  0/359 (0.00%)  1/355 (0.28%) 
C-reactive protein increased * 1  0/359 (0.00%)  1/355 (0.28%) 
Gamma-glutamyltransferase increased * 1  0/359 (0.00%)  1/355 (0.28%) 
Hepatic enzyme increased * 1  0/359 (0.00%)  1/355 (0.28%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  3/359 (0.84%)  0/355 (0.00%) 
Dehydration * 1  10/359 (2.79%)  1/355 (0.28%) 
Hypercalcaemia * 1  1/359 (0.28%)  2/355 (0.56%) 
Hyperkalaemia * 1  2/359 (0.56%)  1/355 (0.28%) 
Hypocalcaemia * 1  0/359 (0.00%)  1/355 (0.28%) 
Hypoglycaemia * 1  1/359 (0.28%)  0/355 (0.00%) 
Hypokalaemia * 1  2/359 (0.56%)  0/355 (0.00%) 
Hyponatraemia * 1  1/359 (0.28%)  3/355 (0.85%) 
Hypovolaemia * 1  1/359 (0.28%)  0/355 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/359 (0.28%)  1/355 (0.28%) 
Back pain * 1  3/359 (0.84%)  2/355 (0.56%) 
Flank pain * 1  0/359 (0.00%)  1/355 (0.28%) 
Musculoskeletal chest pain * 1  0/359 (0.00%)  1/355 (0.28%) 
Pain in extremity * 1  2/359 (0.56%)  0/355 (0.00%) 
Polyarthritis * 1  0/359 (0.00%)  1/355 (0.28%) 
Spinal column stenosis * 1  0/359 (0.00%)  1/355 (0.28%) 
Spondylolisthesis * 1  0/359 (0.00%)  1/355 (0.28%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastasis * 1  1/359 (0.28%)  0/355 (0.00%) 
Metastatic pain * 1  0/359 (0.00%)  1/355 (0.28%) 
Neoplasm progression * 1  1/359 (0.28%)  0/355 (0.00%) 
Renal cell carcinoma * 1  1/359 (0.28%)  1/355 (0.28%) 
Squamous cell carcinoma * 1  0/359 (0.00%)  1/355 (0.28%) 
Tumour associated fever * 1  1/359 (0.28%)  0/355 (0.00%) 
Nervous system disorders     
Aphasia * 1  1/359 (0.28%)  0/355 (0.00%) 
Balance disorder * 1  0/359 (0.00%)  1/355 (0.28%) 
Central nervous system haemorrhage * 1  1/359 (0.28%)  0/355 (0.00%) 
Cerebral infarction * 1  0/359 (0.00%)  1/355 (0.28%) 
Cerebral ischaemia * 1  0/359 (0.00%)  1/355 (0.28%) 
Cerebrovascular accident * 1  2/359 (0.56%)  1/355 (0.28%) 
Dizziness * 1  3/359 (0.84%)  0/355 (0.00%) 
Headache * 1  1/359 (0.28%)  0/355 (0.00%) 
Hemiparesis * 1  0/359 (0.00%)  1/355 (0.28%) 
Ischaemic stroke * 1  0/359 (0.00%)  1/355 (0.28%) 
Leukoencephalopathy * 1  1/359 (0.28%)  0/355 (0.00%) 
Loss of consciousness * 1  2/359 (0.56%)  0/355 (0.00%) 
Meningeal disorder * 1  1/359 (0.28%)  0/355 (0.00%) 
Monoplegia * 1  0/359 (0.00%)  1/355 (0.28%) 
Presyncope * 1  1/359 (0.28%)  0/355 (0.00%) 
Seizure * 1  1/359 (0.28%)  0/355 (0.00%) 
Spinal cord compression * 1  2/359 (0.56%)  0/355 (0.00%) 
Syncope * 1  2/359 (0.56%)  0/355 (0.00%) 
Transient ischaemic attack * 1  3/359 (0.84%)  0/355 (0.00%) 
Psychiatric disorders     
Anxiety * 1  0/359 (0.00%)  1/355 (0.28%) 
Confusional state * 1  1/359 (0.28%)  0/355 (0.00%) 
Disorientation * 1  1/359 (0.28%)  0/355 (0.00%) 
Mental status changes * 1  1/359 (0.28%)  1/355 (0.28%) 
Renal and urinary disorders     
Acute kidney injury * 1  4/359 (1.11%)  2/355 (0.56%) 
Acute prerenal failure * 1  1/359 (0.28%)  0/355 (0.00%) 
Haematuria * 1  1/359 (0.28%)  0/355 (0.00%) 
Nephropathy * 1  0/359 (0.00%)  1/355 (0.28%) 
Oliguria * 1  0/359 (0.00%)  1/355 (0.28%) 
Renal failure * 1  1/359 (0.28%)  0/355 (0.00%) 
Urinary retention * 1  1/359 (0.28%)  0/355 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1 [1]  1/265 (0.38%)  0/258 (0.00%) 
Menometrorrhagia * 1 [1]  0/96 (0.00%)  1/104 (0.96%) 
Vaginal polyp * 1 [1]  1/96 (1.04%)  0/104 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  0/359 (0.00%)  1/355 (0.28%) 
Cough * 1  0/359 (0.00%)  1/355 (0.28%) 
Dyspnoea * 1  7/359 (1.95%)  3/355 (0.85%) 
Dyspnoea exertional * 1  1/359 (0.28%)  0/355 (0.00%) 
Epistaxis * 1  1/359 (0.28%)  1/355 (0.28%) 
Haemoptysis * 1  1/359 (0.28%)  2/355 (0.56%) 
Haemothorax * 1  0/359 (0.00%)  1/355 (0.28%) 
Interstitial lung disease * 1  1/359 (0.28%)  0/355 (0.00%) 
Lung disorder * 1  1/359 (0.28%)  0/355 (0.00%) 
Pleural effusion * 1  3/359 (0.84%)  5/355 (1.41%) 
Pleurisy * 1  0/359 (0.00%)  1/355 (0.28%) 
Pneumothorax * 1  4/359 (1.11%)  1/355 (0.28%) 
Pneumothorax spontaneous * 1  1/359 (0.28%)  0/355 (0.00%) 
Pulmonary embolism * 1  7/359 (1.95%)  1/355 (0.28%) 
Pulmonary haemorrhage * 1  0/359 (0.00%)  2/355 (0.56%) 
Respiratory distress * 1  1/359 (0.28%)  0/355 (0.00%) 
Skin and subcutaneous tissue disorders     
Erythema multiforme * 1  0/359 (0.00%)  3/355 (0.85%) 
Hyperhidrosis * 1  1/359 (0.28%)  0/355 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  0/359 (0.00%)  1/355 (0.28%) 
Pustular psoriasis * 1  0/359 (0.00%)  1/355 (0.28%) 
Rash * 1  0/359 (0.00%)  2/355 (0.56%) 
Urticaria * 1  1/359 (0.28%)  0/355 (0.00%) 
Surgical and medical procedures     
Pain management * 1  0/359 (0.00%)  1/355 (0.28%) 
Vertebroplasty * 1  0/359 (0.00%)  1/355 (0.28%) 
Vascular disorders     
Accelerated hypertension * 1  1/359 (0.28%)  0/355 (0.00%) 
Deep vein thrombosis * 1  1/359 (0.28%)  1/355 (0.28%) 
Hypertension * 1  1/359 (0.28%)  2/355 (0.56%) 
Hypertensive crisis * 1  1/359 (0.28%)  0/355 (0.00%) 
Hypotension * 1  1/359 (0.28%)  4/355 (1.13%) 
Infarction * 1  0/359 (0.00%)  1/355 (0.28%) 
Jugular vein thrombosis * 1  1/359 (0.28%)  0/355 (0.00%) 
Subclavian vein thrombosis * 1  1/359 (0.28%)  0/355 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
[1]
This event was gender specific.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Axitinib 5 mg Sorafenib 400 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   337/359 (93.87%)   346/355 (97.46%) 
Blood and lymphatic system disorders     
Anaemia * 1  18/359 (5.01%)  44/355 (12.39%) 
Endocrine disorders     
Hypothyroidism * 1  74/359 (20.61%)  33/355 (9.30%) 
Gastrointestinal disorders     
Abdominal pain * 1  55/359 (15.32%)  46/355 (12.96%) 
Abdominal pain upper * 1  37/359 (10.31%)  16/355 (4.51%) 
Constipation * 1  79/359 (22.01%)  82/355 (23.10%) 
Diarrhoea * 1  208/359 (57.94%)  195/355 (54.93%) 
Dyspepsia * 1  39/359 (10.86%)  15/355 (4.23%) 
Flatulence * 1  20/359 (5.57%)  8/355 (2.25%) 
Nausea * 1  128/359 (35.65%)  84/355 (23.66%) 
Stomatitis * 1  60/359 (16.71%)  47/355 (13.24%) 
Vomiting * 1  95/359 (26.46%)  69/355 (19.44%) 
General disorders     
Asthenia * 1  78/359 (21.73%)  57/355 (16.06%) 
Chest pain * 1  23/359 (6.41%)  20/355 (5.63%) 
Fatigue * 1  151/359 (42.06%)  122/355 (34.37%) 
Mucosal inflammation * 1  61/359 (16.99%)  45/355 (12.68%) 
Oedema peripheral * 1  22/359 (6.13%)  22/355 (6.20%) 
Pain * 1  19/359 (5.29%)  17/355 (4.79%) 
Pyrexia * 1  26/359 (7.24%)  40/355 (11.27%) 
Infections and infestations     
Nasopharyngitis * 1  25/359 (6.96%)  13/355 (3.66%) 
Investigations     
Blood thyroid stimulating hormone increased * 1  19/359 (5.29%)  11/355 (3.10%) 
Lipase increased * 1  13/359 (3.62%)  22/355 (6.20%) 
Weight decreased * 1  111/359 (30.92%)  83/355 (23.38%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  140/359 (39.00%)  112/355 (31.55%) 
Dehydration * 1  18/359 (5.01%)  10/355 (2.82%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  62/359 (17.27%)  46/355 (12.96%) 
Back pain * 1  59/359 (16.43%)  54/355 (15.21%) 
Muscle spasms * 1  11/359 (3.06%)  21/355 (5.92%) 
Musculoskeletal pain * 1  28/359 (7.80%)  27/355 (7.61%) 
Myalgia * 1  28/359 (7.80%)  12/355 (3.38%) 
Pain in extremity * 1  49/359 (13.65%)  53/355 (14.93%) 
Nervous system disorders     
Dizziness * 1  33/359 (9.19%)  21/355 (5.92%) 
Dysgeusia * 1  43/359 (11.98%)  31/355 (8.73%) 
Headache * 1  55/359 (15.32%)  43/355 (12.11%) 
Psychiatric disorders     
Insomnia * 1  33/359 (9.19%)  21/355 (5.92%) 
Renal and urinary disorders     
Proteinuria * 1  49/359 (13.65%)  32/355 (9.01%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  68/359 (18.94%)  70/355 (19.72%) 
Dysphonia * 1  116/359 (32.31%)  49/355 (13.80%) 
Dyspnoea * 1  64/359 (17.83%)  53/355 (14.93%) 
Dyspnoea exertional * 1  18/359 (5.01%)  11/355 (3.10%) 
Epistaxis * 1  28/359 (7.80%)  19/355 (5.35%) 
Haemoptysis * 1  8/359 (2.23%)  18/355 (5.07%) 
Oropharyngeal pain * 1  22/359 (6.13%)  21/355 (5.92%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  18/359 (5.01%)  122/355 (34.37%) 
Dry skin * 1  36/359 (10.03%)  42/355 (11.83%) 
Erythema * 1  12/359 (3.34%)  39/355 (10.99%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  100/359 (27.86%)  183/355 (51.55%) 
Pruritus * 1  25/359 (6.96%)  48/355 (13.52%) 
Rash * 1  53/359 (14.76%)  109/355 (30.70%) 
Vascular disorders     
Hypertension * 1  156/359 (43.45%)  107/355 (30.14%) 
Hypotension * 1  19/359 (5.29%)  6/355 (1.69%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
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):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00678392     History of Changes
Other Study ID Numbers: A4061032
AXIS TRIAL
2008-001451-21 ( EudraCT Number )
AXIS ( Other Identifier: Alias Study Number )
First Submitted: May 12, 2008
First Posted: May 15, 2008
Results First Submitted: February 25, 2012
Results First Posted: March 27, 2012
Last Update Posted: January 9, 2019