Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients (ATLAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01599754
Recruitment Status : Terminated (Primary endpoint did not reach statistical significance)
First Posted : May 16, 2012
Results First Posted : August 26, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
Pfizer
SFJ Pharmaceuticals, Inc.
Information provided by (Responsible Party):
SFJ Pharmaceuticals, Inc. ( SFJ Pharma Ltd. II )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Clear Cell Renal Carcinoma
Interventions Drug: Axitinib
Drug: Placebo
Enrollment 724
Recruitment Details A total of 128 study sites in 9 countries randomized 724 participants into this study.
Pre-assignment Details  
Arm/Group Title Axitinib Placebo
Hide Arm/Group Description Participants at high risk of recurrent renal cell carcinoma (RCC) received Axitinib 5 milligram (mg) twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment. Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Period Title: Overall Study
Started 363 361
Treated 360 360
Completed 0 1
Not Completed 363 360
Reason Not Completed
Anticancer therapy need not in protocol             5             2
Participant noncompliance             4             4
Lost to Follow-up             13             6
Death             31             33
Adverse Event             3             2
Investigator decision             1             3
Withdrawal by Subject             24             25
Study terminated by sponsor             282             285
Arm/Group Title Axitinib Placebo Total
Hide Arm/Group Description Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment. . Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment. Total of all reporting groups
Overall Number of Baseline Participants 363 361 724
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) population included all randomized participants regardless of whether or not treatment was administered and based on randomized treatment assignment.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 363 participants 361 participants 724 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
255
  70.2%
247
  68.4%
502
  69.3%
>=65 years
108
  29.8%
114
  31.6%
222
  30.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 363 participants 361 participants 724 participants
57.9  (10.80) 58.1  (11.33) 58.0  (11.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 363 participants 361 participants 724 participants
Female
83
  22.9%
111
  30.7%
194
  26.8%
Male
280
  77.1%
250
  69.3%
530
  73.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 363 participants 361 participants 724 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
264
  72.7%
267
  74.0%
531
  73.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   0.8%
1
   0.3%
4
   0.6%
White
91
  25.1%
90
  24.9%
181
  25.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
   1.4%
3
   0.8%
8
   1.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 363 participants 361 participants 724 participants
South Korea 87 88 175
Hong Kong 6 5 11
United States 50 47 97
Japan 81 79 160
China 63 65 128
Taiwan 18 19 37
France 23 23 46
India 7 8 15
Spain 28 27 55
BMI   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 363 participants 361 participants 724 participants
Normal Weight
187
  51.5%
173
  47.9%
360
  49.7%
Overweight + Obese
165
  45.5%
175
  48.5%
340
  47.0%
Overweight
115
  31.7%
124
  34.3%
239
  33.0%
Obese
50
  13.8%
51
  14.1%
101
  14.0%
Underweight
7
   1.9%
12
   3.3%
19
   2.6%
Missing
4
   1.1%
1
   0.3%
5
   0.7%
[1]
Measure Description: Categorization of participants on body mass index (BMI): Normal (18.5 less than or equal to [<=] BMI less than [<] 25), Overweight + Obese (BMI greater than or equal to [>=] 25), Overweight (25<=BMI<30), Obese (BMI>=30) and Underweight (BMI<18.5).
1.Primary Outcome
Title Disease Free Survival (DFS) as Assessed by Blinded Independent Review Committee (IRC)
Hide Description DFS is defined as time interval from the date of randomization to first date of recurrence/relapse (distant or local recurrence of [RCC] or occurrence of a secondary malignancy {occurrence of a second primary cancer other than RCC} or death). For participants with no DFS event, DFS was censored at date of last scan prior to time of analyses. Participants alive who did not have post-baseline disease assessments, DFS was censored at randomization. Participants who received further anti-tumor therapy prior to recurrence or occurrence of a secondary malignancy or death, DFS was censored on date of last scan prior to taking anti-tumor medication. Participants who missed 2 or more consecutive tumor scans immediately followed by an event were censored at date of last objective tumor assessment prior to missing/not readable scan.
Time Frame From randomization date up to first date of recurrence or the occurrence of a secondary malignancy or death (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants regardless of whether or not treatment was administered and based on randomized treatment assignment.
Arm/Group Title Axitinib Placebo
Hide Arm/Group Description:
Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Overall Number of Participants Analyzed 363 361
Median (95% Confidence Interval)
Unit of Measure: years
NA [1] 
(4.1 to NA)
NA [1] 
(4.1 to NA)
[1]
Median and upper limit of CI was not estimable due to low number of participants who had event.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Axitinib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3211
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.870
Confidence Interval (2-Sided) 95%
0.660 to 1.147
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. Participants lacking data beyond randomization had their survival times censored at randomization.
Time Frame From randomization date until death due to any cause (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants regardless of whether or not treatment was administered and based on randomized treatment assignment.
Arm/Group Title Axitinib Placebo
Hide Arm/Group Description:
Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Overall Number of Participants Analyzed 363 361
Median (95% Confidence Interval)
Unit of Measure: years
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median, upper and lower limit of CI was not estimable due to low number of participants who had event.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Axitinib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9246
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.026
Confidence Interval (2-Sided) 95%
0.600 to 1.756
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Treatment‑Emergent Adverse Events (AE) 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 non-serious adverse events.
Time Frame From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
As-Treated 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 Placebo
Hide Arm/Group Description:
Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Overall Number of Participants Analyzed 360 360
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
353
  98.1%
333
  92.5%
SAEs
75
  20.8%
54
  15.0%
4.Secondary Outcome
Title Number of Participants With Treatment‑Emergent Treatment Related Adverse Events and Serious Adverse Events (SAEs)
Hide Description A treatment related AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event had a causal relationship with the treatment or usage. A 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. Relatedness was judged by investigator. AEs included both serious and non-serious adverse events.
Time Frame From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
As-Treated 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 Placebo
Hide Arm/Group Description:
Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Overall Number of Participants Analyzed 360 360
Measure Type: Count of Participants
Unit of Measure: Participants
Treatment Related AEs
326
  90.6%
202
  56.1%
Treatment Related SAEs
27
   7.5%
9
   2.5%
5.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) 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. 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. AE was assessed according to severity as: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).
Time Frame From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
As-Treated 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 Placebo
Hide Arm/Group Description:
Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Overall Number of Participants Analyzed 360 360
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
23
   6.4%
69
  19.2%
Grade 2
108
  30.0%
152
  42.2%
Grade 3
208
  57.8%
103
  28.6%
Grade 4
12
   3.3%
8
   2.2%
Grade 5
2
   0.6%
1
   0.3%
6.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology
Hide Description Hematology parameters included anemia, hemoglobin increased, lymphocyte count increased, lymphocyte count decreased, neutrophil count decreased, platelet count decreased, and white blood cell count decreased. CTCAE grades: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).
Time Frame From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "number analyzed" signifies number of participants evaluable for specified categories.
Arm/Group Title Axitinib Placebo
Hide Arm/Group Description:
Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Overall Number of Participants Analyzed 360 360
Measure Type: Count of Participants
Unit of Measure: Participants
Anemia Number Analyzed 351 participants 355 participants
Grade 1
256
  72.9%
233
  65.6%
Grade 2
87
  24.8%
114
  32.1%
Grade 3
8
   2.3%
6
   1.7%
Grade 4
0
   0.0%
2
   0.6%
Grade 5
0
   0.0%
0
   0.0%
Hemoglobin increased Number Analyzed 351 participants 355 participants
Grade 1
328
  93.4%
354
  99.7%
Grade 2
23
   6.6%
1
   0.3%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
Grade 5
0
   0.0%
0
   0.0%
Lymphocyte count decreased Number Analyzed 351 participants 355 participants
Grade 1
305
  86.9%
282
  79.4%
Grade 2
26
   7.4%
39
  11.0%
Grade 3
19
   5.4%
33
   9.3%
Grade 4
1
   0.3%
1
   0.3%
Grade 5
0
   0.0%
0
   0.0%
Lymphocyte count increased Number Analyzed 351 participants 355 participants
Grade 1
343
  97.7%
339
  95.5%
Grade 2
0
   0.0%
0
   0.0%
Grade 3
8
   2.3%
16
   4.5%
Grade 4
0
   0.0%
0
   0.0%
Grade 5
0
   0.0%
0
   0.0%
Neutrophil count decreased Number Analyzed 351 participants 355 participants
Grade 1
284
  80.9%
299
  84.2%
Grade 2
48
  13.7%
45
  12.7%
Grade 3
19
   5.4%
8
   2.3%
Grade 4
0
   0.0%
3
   0.8%
Grade 5
0
   0.0%
0
   0.0%
Platelet count decreased Number Analyzed 349 participants 354 participants
Grade 1
267
  76.5%
303
  85.6%
Grade 2
77
  22.1%
49
  13.8%
Grade 3
5
   1.4%
1
   0.3%
Grade 4
0
   0.0%
1
   0.3%
Grade 5
0
   0.0%
0
   0.0%
White blood cell count decreased Number Analyzed 351 participants 355 participants
Grade 1
288
  82.1%
281
  79.2%
Grade 2
55
  15.7%
67
  18.9%
Grade 3
8
   2.3%
6
   1.7%
Grade 4
0
   0.0%
1
   0.3%
Grade 5
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry
Hide Description Chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase increased, creatinine increased, hypoalbuminemia, hypercalcemia, hypocalcemia, hyperglycemia, hypoglycemia, hyperkalemia, hypokalemia, hypernatremia, hyponatremia. CTCAE grades: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).
Time Frame From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "number analyzed" signifies number of participants evaluable for specified categories.
Arm/Group Title Axitinib Placebo
Hide Arm/Group Description:
Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Overall Number of Participants Analyzed 360 360
Measure Type: Count of Participants
Unit of Measure: Participants
Alanine aminotransferase increased Number Analyzed 2 participants 6 participants
Grade 1
1
  50.0%
2
  33.3%
Grade 2
0
   0.0%
3
  50.0%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
1
  50.0%
1
  16.7%
Grade 5
0
   0.0%
0
   0.0%
Alkaline phosphatase increased, Number Analyzed 351 participants 355 participants
Grade 1
298
  84.9%
316
  89.0%
Grade 2
53
  15.1%
37
  10.4%
Grade 3
0
   0.0%
2
   0.6%
Grade 4
0
   0.0%
0
   0.0%
Grade 5
0
   0.0%
0
   0.0%
Aspartate aminotransferase increased Number Analyzed 3 participants 6 participants
Grade 1
0
   0.0%
1
  16.7%
Grade 2
2
  66.7%
1
  16.7%
Grade 3
1
  33.3%
3
  50.0%
Grade 4
0
   0.0%
1
  16.7%
Grade 5
0
   0.0%
0
   0.0%
Blood bilirubin increased Number Analyzed 351 participants 355 participants
Grade 1
315
  89.7%
330
  93.0%
Grade 2
30
   8.5%
18
   5.1%
Grade 3
6
   1.7%
6
   1.7%
Grade 4
0
   0.0%
1
   0.3%
Grade 5
0
   0.0%
0
   0.0%
Creatine phosphokinase increased Number Analyzed 2 participants 2 participants
Grade 1
0
   0.0%
0
   0.0%
Grade 2
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
2
 100.0%
1
  50.0%
Grade 5
0
   0.0%
1
  50.0%
Creatinine increased Number Analyzed 351 participants 355 participants
Grade 1
13
   3.7%
7
   2.0%
Grade 2
274
  78.1%
301
  84.8%
Grade 3
60
  17.1%
46
  13.0%
Grade 4
3
   0.9%
0
   0.0%
Grade 5
1
   0.3%
1
   0.3%
Hypoalbuminemia Number Analyzed 351 participants 355 participants
Grade 1
347
  98.9%
348
  98.0%
Grade 2
4
   1.1%
5
   1.4%
Grade 3
0
   0.0%
2
   0.6%
Grade 4
0
   0.0%
0
   0.0%
Grade 5
0
   0.0%
0
   0.0%
Hypercalcemia Number Analyzed 351 participants 355 participants
Grade 1
335
  95.4%
344
  96.9%
Grade 2
16
   4.6%
11
   3.1%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
Grade 5
0
   0.0%
0
   0.0%
Hypocalcemia Number Analyzed 351 participants 355 participants
Grade 1
280
  79.8%
266
  74.9%
Grade 2
64
  18.2%
85
  23.9%
Grade 3
3
   0.9%
4
   1.1%
Grade 4
2
   0.6%
0
   0.0%
Grade 5
2
   0.6%
0
   0.0%
Hyperglycemia Number Analyzed 351 participants 355 participants
Grade 1
116
  33.0%
115
  32.4%
Grade 2
160
  45.6%
159
  44.8%
Grade 3
62
  17.7%
56
  15.8%
Grade 4
12
   3.4%
23
   6.5%
Grade 5
1
   0.3%
2
   0.6%
Hypoglycemia Number Analyzed 351 participants 355 participants
Grade 1
230
  65.5%
246
  69.3%
Grade 2
111
  31.6%
101
  28.5%
Grade 3
9
   2.6%
6
   1.7%
Grade 4
0
   0.0%
1
   0.3%
Grade 5
1
   0.3%
1
   0.3%
Hyperkalemia Number Analyzed 351 participants 355 participants
Grade 1
318
  90.6%
325
  91.5%
Grade 2
1
   0.3%
0
   0.0%
Grade 3
26
   7.4%
21
   5.9%
Grade 4
6
   1.7%
9
   2.5%
Grade 5
0
   0.0%
0
   0.0%
Hypokalemia Number Analyzed 351 participants 355 participants
Grade 1
340
  96.9%
348
  98.0%
Grade 2
9
   2.6%
7
   2.0%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
2
   0.6%
0
   0.0%
Grade 5
0
   0.0%
0
   0.0%
Hypernatremia Number Analyzed 351 participants 355 participants
Grade 1
245
  69.8%
245
  69.0%
Grade 2
96
  27.4%
94
  26.5%
Grade 3
8
   2.3%
14
   3.9%
Grade 4
2
   0.6%
2
   0.6%
Grade 5
0
   0.0%
0
   0.0%
Hyponatremia Number Analyzed 351 participants 355 participants
Grade 1
331
  94.3%
338
  95.2%
Grade 2
13
   3.7%
11
   3.1%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
7
   2.0%
5
   1.4%
Grade 5
0
   0.0%
1
   0.3%
8.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities: Thyroid Function
Hide Description Number of participants with thyrotropin levels: <5 milli-international units per litre (mIU/L), >=5 to <10 mIU/L, >=10 mIU/L are reported.
Time Frame From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Axitinib Placebo
Hide Arm/Group Description:
Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Overall Number of Participants Analyzed 351 356
Measure Type: Count of Participants
Unit of Measure: Participants
<5 mIU/L
160
  45.6%
308
  86.5%
>=5 - <10 mIU/L
105
  29.9%
37
  10.4%
>=10 mIU/L
86
  24.5%
11
   3.1%
9.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities: Urinalysis
Hide Description Number of participants with urine protein dipstick grading: negative/trace (5 to 20 milligram per deciliter [mg/dL]), 1+ (30 mg/dL]), 2+ (100 mg/dL), 3+ (300 mg/dL) and 4+ (more than 1000 mg/dL) are reported.
Time Frame From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Axitinib Placebo
Hide Arm/Group Description:
Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
Overall Number of Participants Analyzed 351 355
Measure Type: Count of Participants
Unit of Measure: Participants
Negative/trace
135
  38.5%
237
  66.8%
1+
88
  25.1%
84
  23.7%
2+
74
  21.1%
24
   6.8%
3+
49
  14.0%
8
   2.3%
4+
5
   1.4%
2
   0.6%
Time Frame From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Adverse Event Reporting Description Same event may appear as both an AE and SAE. However,what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. As-Treated population consists of 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 Placebo
Hide Arm/Group Description Participants at high risk of recurrent RCC received Axitinib 5 mg twice a day, in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment. Participants at high risk of RCC received placebo matched to Axitinib twice a day in cycles of 4 weeks, up to 3 years with a minimum treatment duration of 1 year unless relapse, the occurrence of secondary malignancy or death occurred prior to 1 year. Participants were followed up after every 6 months after end of treatment.
All-Cause Mortality
Axitinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   31/360 (8.61%)   33/360 (9.17%) 
Show Serious Adverse Events Hide Serious Adverse Events
Axitinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   75/360 (20.83%)   54/360 (15.00%) 
Cardiac disorders     
Acute Coronary Syndrome  1  3/360 (0.83%)  0/360 (0.00%) 
Acute Myocardial Infarction  1  3/360 (0.83%)  1/360 (0.28%) 
Angina Pectoris  1  2/360 (0.56%)  0/360 (0.00%) 
Angina Unstable  1  0/360 (0.00%)  1/360 (0.28%) 
Atrial Fibrillation  1  1/360 (0.28%)  0/360 (0.00%) 
Cardiac Failure Congestive  1  2/360 (0.56%)  0/360 (0.00%) 
Myocardial Infarction  1  1/360 (0.28%)  0/360 (0.00%) 
Stress Cardiomyopathy  1  0/360 (0.00%)  1/360 (0.28%) 
Eye disorders     
Cataract  1  1/360 (0.28%)  0/360 (0.00%) 
Retinal Haemorrhage  1  1/360 (0.28%)  0/360 (0.00%) 
Gastrointestinal disorders     
Abdominal Discomfort  1  0/360 (0.00%)  1/360 (0.28%) 
Abdominal Hernia  1  1/360 (0.28%)  1/360 (0.28%) 
Abdominal Pain  1  2/360 (0.56%)  0/360 (0.00%) 
Anal Fistula  1  0/360 (0.00%)  1/360 (0.28%) 
Diarrhoea  1  2/360 (0.56%)  0/360 (0.00%) 
Enteritis  1  1/360 (0.28%)  0/360 (0.00%) 
Gastric Ulcer  1  0/360 (0.00%)  1/360 (0.28%) 
Haemorrhoidal Haemorrhage  1  1/360 (0.28%)  0/360 (0.00%) 
Intestinal Polyp  1  0/360 (0.00%)  1/360 (0.28%) 
Large Intestinal Stenosis  1  1/360 (0.28%)  0/360 (0.00%) 
Large Intestine Polyp  1  0/360 (0.00%)  2/360 (0.56%) 
Nausea  1  0/360 (0.00%)  1/360 (0.28%) 
Oesophageal Disorder  1  1/360 (0.28%)  0/360 (0.00%) 
Pancreatic Cyst  1  1/360 (0.28%)  0/360 (0.00%) 
Pancreatitis Acute  1  2/360 (0.56%)  0/360 (0.00%) 
Small Intestinal Obstruction  1  1/360 (0.28%)  0/360 (0.00%) 
Umbilical Hernia  1  1/360 (0.28%)  0/360 (0.00%) 
Upper Gastrointestinal Haemorrhage  1  1/360 (0.28%)  0/360 (0.00%) 
General disorders     
Asthenia  1  1/360 (0.28%)  0/360 (0.00%) 
Inflammation  1  0/360 (0.00%)  1/360 (0.28%) 
Hepatobiliary disorders     
Biliary Colic  1  1/360 (0.28%)  0/360 (0.00%) 
Cholangitis Acute  1  0/360 (0.00%)  1/360 (0.28%) 
Cholecystitis  1  5/360 (1.39%)  1/360 (0.28%) 
Cholelithiasis  1  1/360 (0.28%)  0/360 (0.00%) 
Livery Injury  1  0/360 (0.00%)  1/360 (0.28%) 
Immune system disorders     
Anaphylactic Reaction  1  1/360 (0.28%)  0/360 (0.00%) 
Anaphylactic Shock  1  0/360 (0.00%)  1/360 (0.28%) 
Infections and infestations     
Abdominal Abscess  1  0/360 (0.00%)  1/360 (0.28%) 
Anal Abscess  1  1/360 (0.28%)  0/360 (0.00%) 
Appendicitis  1  2/360 (0.56%)  1/360 (0.28%) 
Cellulitis  1  0/360 (0.00%)  1/360 (0.28%) 
Diarrhoea Infectious  1  0/360 (0.00%)  1/360 (0.28%) 
Diverticulitis  1  1/360 (0.28%)  0/360 (0.00%) 
Gastroenteritis  1  1/360 (0.28%)  0/360 (0.00%) 
Herpes Zoster  1  0/360 (0.00%)  1/360 (0.28%) 
Orchitis  1  1/360 (0.28%)  0/360 (0.00%) 
Otitis Externa  1  1/360 (0.28%)  0/360 (0.00%) 
Otitis Media Chronic  1  1/360 (0.28%)  0/360 (0.00%) 
Pneumonia  1  0/360 (0.00%)  1/360 (0.28%) 
Pneumonia Bacterial  1  2/360 (0.56%)  0/360 (0.00%) 
Pulmonary Tuberculosis  1  1/360 (0.28%)  0/360 (0.00%) 
Pyelonephritis Acute  1  1/360 (0.28%)  0/360 (0.00%) 
Tonsillitis  1  1/360 (0.28%)  0/360 (0.00%) 
Urinary Tract Infection  1  0/360 (0.00%)  1/360 (0.28%) 
Injury, poisoning and procedural complications     
Abdominal Wound Dehiscence  1  1/360 (0.28%)  0/360 (0.00%) 
Fibula Fracture  1  1/360 (0.28%)  0/360 (0.00%) 
Head Injury  1  0/360 (0.00%)  1/360 (0.28%) 
Humerus Fracture  1  0/360 (0.00%)  1/360 (0.28%) 
Ligament Injury  1  0/360 (0.00%)  1/360 (0.28%) 
Ligament Sprain  1  1/360 (0.28%)  0/360 (0.00%) 
Meniscus Injury  1  1/360 (0.28%)  0/360 (0.00%) 
Multiple Fractures  1  0/360 (0.00%)  1/360 (0.28%) 
Snake Bite  1  1/360 (0.28%)  0/360 (0.00%) 
Spinal Compression Fracture  1  0/360 (0.00%)  1/360 (0.28%) 
Wound  1  1/360 (0.28%)  0/360 (0.00%) 
Wrist Fracture  1  0/360 (0.00%)  1/360 (0.28%) 
Metabolism and nutrition disorders     
Dehydration  1  1/360 (0.28%)  0/360 (0.00%) 
Diabetes Mellitus  1  1/360 (0.28%)  1/360 (0.28%) 
Hyperglycaemia  1  2/360 (0.56%)  1/360 (0.28%) 
Hyperlipidaemia  1  1/360 (0.28%)  0/360 (0.00%) 
Hyponatraemia  1  0/360 (0.00%)  1/360 (0.28%) 
Musculoskeletal and connective tissue disorders     
Bursitis  1  1/360 (0.28%)  0/360 (0.00%) 
Pathological Fracture  1  0/360 (0.00%)  1/360 (0.28%) 
Rhabdomyolysis  1  0/360 (0.00%)  1/360 (0.28%) 
Spinal Column Stenosis  1  0/360 (0.00%)  1/360 (0.28%) 
Spondylolisthesis  1  0/360 (0.00%)  1/360 (0.28%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bile Duct Cancer  1  0/360 (0.00%)  1/360 (0.28%) 
Bladder Cancer  1  1/360 (0.28%)  0/360 (0.00%) 
Bronchial Neoplasm  1  0/360 (0.00%)  1/360 (0.28%) 
Colon Cancer  1  1/360 (0.28%)  0/360 (0.00%) 
Gastric Cancer  1  0/360 (0.00%)  1/360 (0.28%) 
Gastrointestinal Tract Adenoma  1  1/360 (0.28%)  0/360 (0.00%) 
Kaposi's Sarcoma  1  0/360 (0.00%)  1/360 (0.28%) 
Laryngeal Cancer  1  0/360 (0.00%)  1/360 (0.28%) 
Lung Neoplasm Malignant  1  0/360 (0.00%)  2/360 (0.56%) 
Papillary Thyroid Cancer  1  0/360 (0.00%)  1/360 (0.28%) 
Prostate Cancer  1  0/360 (0.00%)  1/360 (0.28%) 
Rectal Cancer  1  1/360 (0.28%)  0/360 (0.00%) 
Small Intestine Carcinoma  1  0/360 (0.00%)  1/360 (0.28%) 
Squamous Cell Carcinoma  1  1/360 (0.28%)  0/360 (0.00%) 
Squamous Cell Carcinoma of the Oral Cavity  1  0/360 (0.00%)  1/360 (0.28%) 
Thymoma  1  0/360 (0.00%)  1/360 (0.28%) 
Transitional Cell Carcinoma  1  0/360 (0.00%)  1/360 (0.28%) 
Nervous system disorders     
Cerebral Haemorrhage  1  1/360 (0.28%)  0/360 (0.00%) 
Cerebral Infarction  1  2/360 (0.56%)  0/360 (0.00%) 
Haemorrhagic Stroke  1  1/360 (0.28%)  0/360 (0.00%) 
Intracranial Aneurysm  1  0/360 (0.00%)  1/360 (0.28%) 
Loss of Consciousness  1  0/360 (0.00%)  1/360 (0.28%) 
Myelopathy  1  1/360 (0.28%)  0/360 (0.00%) 
Transient Ischaemic Attack  1  0/360 (0.00%)  1/360 (0.28%) 
Psychiatric disorders     
Alcohol Withdrawal Syndrome  1  0/360 (0.00%)  1/360 (0.28%) 
Completed Suicide  1  1/360 (0.28%)  1/360 (0.28%) 
Depression  1  1/360 (0.28%)  1/360 (0.28%) 
Suicide Attempt  1  1/360 (0.28%)  1/360 (0.28%) 
Renal and urinary disorders     
Acute Kidney Injury  1  2/360 (0.56%)  1/360 (0.28%) 
Bladder Neck Obstruction  1  0/360 (0.00%)  1/360 (0.28%) 
Haematuria  1  0/360 (0.00%)  1/360 (0.28%) 
Nephrolithiasis  1  2/360 (0.56%)  0/360 (0.00%) 
Renal Disorder  1  1/360 (0.28%)  0/360 (0.00%) 
Ureterolithiasis  1  0/360 (0.00%)  1/360 (0.28%) 
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia  1  1/360 (0.28%)  1/360 (0.28%) 
Variococele  1  1/360 (0.28%)  0/360 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic Obstructive Pulmonary Disease  1  0/360 (0.00%)  1/360 (0.28%) 
Dyspnoea  1  1/360 (0.28%)  0/360 (0.00%) 
Pneumothorax  1  2/360 (0.56%)  0/360 (0.00%) 
Sleep Apnoea Syndrome  1  0/360 (0.00%)  1/360 (0.28%) 
Skin and subcutaneous tissue disorders     
Toxic Skin Eruption  1  1/360 (0.28%)  0/360 (0.00%) 
Vascular disorders     
Aortic Intramural Haematoma  1  1/360 (0.28%)  0/360 (0.00%) 
Hypertension  1  2/360 (0.56%)  0/360 (0.00%) 
Peripheral Artery Aneurysm  1  1/360 (0.28%)  0/360 (0.00%) 
1
Term from vocabulary, MedDRA v21.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Axitinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   353/360 (98.06%)   332/360 (92.22%) 
Endocrine disorders     
Hypothyroidism  1  73/360 (20.28%)  22/360 (6.11%) 
Gastrointestinal disorders     
Abdominal Pain  1  25/360 (6.94%)  17/360 (4.72%) 
Abdominal Pain Upper  1  25/360 (6.94%)  10/360 (2.78%) 
Consitpation  1  24/360 (6.67%)  23/360 (6.39%) 
Diarrhoea  1  168/360 (46.67%)  52/360 (14.44%) 
Dyspepsia  1  22/360 (6.11%)  10/360 (2.78%) 
Nausea  1  36/360 (10.00%)  34/360 (9.44%) 
Stomatitis  1  46/360 (12.78%)  9/360 (2.50%) 
Vomiting  1  20/360 (5.56%)  16/360 (4.44%) 
General disorders     
Asthenia  1  41/360 (11.39%)  22/360 (6.11%) 
Fatigue  1  75/360 (20.83%)  44/360 (12.22%) 
Malaise  1  19/360 (5.28%)  10/360 (2.78%) 
Pyrexia  1  13/360 (3.61%)  19/360 (5.28%) 
Infections and infestations     
Nasopharyngitis  1  57/360 (15.83%)  62/360 (17.22%) 
Upper Respiratory Tract Infection  1  33/360 (9.17%)  32/360 (8.89%) 
Investigations     
Alanine Aminotransferase Increased  1  31/360 (8.61%)  13/360 (3.61%) 
Aspartate Aminotransferase Increased  1  28/360 (7.78%)  11/360 (3.06%) 
Blood Creatinine Increased  1  34/360 (9.44%)  23/360 (6.39%) 
Blood Thyroid Stimulating Hormone Increased  1  48/360 (13.33%)  5/360 (1.39%) 
Weight Decreased  1  25/360 (6.94%)  5/360 (1.39%) 
Weight Increased  1  18/360 (5.00%)  35/360 (9.72%) 
Metabolism and nutrition disorders     
Decreased Appetite  1  45/360 (12.50%)  7/360 (1.94%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  59/360 (16.39%)  36/360 (10.00%) 
Back Pain  1  46/360 (12.78%)  54/360 (15.00%) 
Musculoskeletal Pain  1  21/360 (5.83%)  10/360 (2.78%) 
Myalgia  1  25/360 (6.94%)  11/360 (3.06%) 
Pain In Extremity  1  35/360 (9.72%)  23/360 (6.39%) 
Nervous system disorders     
Dizziness  1  42/360 (11.67%)  34/360 (9.44%) 
Dysgeusia  1  24/360 (6.67%)  5/360 (1.39%) 
Headache  1  48/360 (13.33%)  40/360 (11.11%) 
Psychiatric disorders     
Insomnia  1  20/360 (5.56%)  18/360 (5.00%) 
Renal and urinary disorders     
Proteniurea  1  84/360 (23.33%)  25/360 (6.94%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  34/360 (9.44%)  28/360 (7.78%) 
Dysphonia  1  149/360 (41.39%)  21/360 (5.83%) 
Dyspnoea  1  19/360 (5.28%)  11/360 (3.06%) 
Epistaxis  1  29/360 (8.06%)  4/360 (1.11%) 
Oropharyngeal Pain  1  20/360 (5.56%)  12/360 (3.33%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  20/360 (5.56%)  11/360 (3.06%) 
Dry Skin  1  25/360 (6.94%)  14/360 (3.89%) 
Palmar-Plantar Ertythrodysaesthesia Syndrome  1  115/360 (31.94%)  17/360 (4.72%) 
Pruritus  1  23/360 (6.39%)  31/360 (8.61%) 
Rash  1  46/360 (12.78%)  15/360 (4.17%) 
Vascular disorders     
Hypertension  1  231/360 (64.17%)  91/360 (25.28%) 
1
Term from vocabulary, MedDRA v21.0
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stewart Hallett
Organization: SFJ Pharmaceuticals
Phone: 19252011003
EMail: stewart.hallett@sfj-pharma.com
Layout table for additonal information
Responsible Party: SFJ Pharmaceuticals, Inc. ( SFJ Pharma Ltd. II )
ClinicalTrials.gov Identifier: NCT01599754     History of Changes
Other Study ID Numbers: AP311736
First Submitted: May 11, 2012
First Posted: May 16, 2012
Results First Submitted: May 31, 2019
Results First Posted: August 26, 2019
Last Update Posted: September 20, 2019