Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00282048
Recruitment Status : Completed
First Posted : January 25, 2006
Results First Posted : April 3, 2012
Last Update Posted : July 31, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Kidney Neoplasms
Carcinoma, Renal Cell
Intervention Drug: AG-013736 (axitinib)
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Axitinib
Hide Arm/Group Description Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
Period Title: Overall Study
Started 62
Completed 0
Not Completed 62
Reason Not Completed
Lack of Efficacy             30
Adverse Event             22
Withdrawal by Subject             1
Other             8
Ongoing             1
Arm/Group Title Axitinib
Hide Arm/Group Description Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
Overall Number of Baseline Participants 62
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants
57.9  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants
Female
20
  32.3%
Male
42
  67.7%
1.Primary Outcome
Title Percentage of Participants With Objective Response (OR)
Hide Description Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of responses. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions.
Time Frame Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type.
Arm/Group Title Axitinib
Hide Arm/Group Description:
Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
Overall Number of Participants Analyzed 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
22.6
(12.9 to 35.0)
2.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Time Frame Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 152 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type.
Arm/Group Title Axitinib
Hide Arm/Group Description:
Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
Overall Number of Participants Analyzed 62
Median (95% Confidence Interval)
Unit of Measure: Days
225
(203 to 334)
3.Secondary Outcome
Title Duration of Response (DR)
Hide Description Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time Frame Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).
Arm/Group Title Axitinib
Hide Arm/Group Description:
Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
Overall Number of Participants Analyzed 14
Median (95% Confidence Interval)
Unit of Measure: Days
531 [1] 
(225 to NA)
[1]
The upper limit was not estimable because large number of participants were censored.
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.
Time Frame Baseline to death due to any cause or at least 1 year after the first dose for the last participant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type.
Arm/Group Title Axitinib
Hide Arm/Group Description:
Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
Overall Number of Participants Analyzed 62
Median (95% Confidence Interval)
Unit of Measure: Days
412.5
(256.0 to 570.0)
5.Secondary Outcome
Title Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index for Disease Cancer Related Symptoms (FKSI-DRS) Score
Hide Description FKSI-DRS is a subset of FKSI which is a questionnaire for FACT -Kidney Symptom Index used to assess Quality of Life (QoL)/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS.
Time Frame Baseline (Day 1 of Cycle 1), Day 1 of all subsequent cycles up to Cycle 38 and follow up (28 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type. 'n' is the number of participants who completed at least one question.
Arm/Group Title Axitinib
Hide Arm/Group Description:
Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
Overall Number of Participants Analyzed 62
Mean (95% Confidence Interval)
Unit of Measure: Units on a Scale
Baseline (n=62)
28.94
(27.69 to 30.19)
Day 1 (Cycle 2) (n=52)
27.12
(25.76 to 28.47)
Day 1 (Cycle 3) (n=46)
27.11
(25.79 to 28.43)
Day 1 (Cycle 4) (n=41)
27.68
(26.21 to 29.16)
Day 1 (Cycle 5) (n=39)
27.94
(26.55 to 29.34)
Day 1 (Cycle 6) (n=33)
27.31
(25.52 to 29.11)
Day 1 (Cycle 7) (n=32)
28.56
(26.79 to 30.33)
Day 1 (Cycle 8) (n=30)
28.55
(26.58 to 30.53)
Day 1 (Cycle 9) (n=27)
28.75
(27.05 to 30.44)
Day 1 (Cycle 10) (n=19)
29.37
(27.40 to 31.34)
Day 1 (Cycle 11) (n=17)
29.35
(27.13 to 31.57)
Day 1 (Cycle 12) (n=17)
29.24
(26.67 to 31.80)
Day 1 (Cycle 13) (n=16)
30.41
(28.27 to 32.56)
Day 1 (Cycle 14) (n=15)
31.02
(29.56 to 32.47)
Day 1 (Cycle 15) (n=14)
30.29
(28.48 to 32.09)
Day 1 (Cycle 16) (n=14)
30.79
(28.88 to 32.70)
Day 1 (Cycle 17) (n=13)
31.46
(29.10 to 33.82)
Day 1 (Cycle 18) (n=12)
31.08
(29.20 to 32.97)
Day 1 (Cycle 19) (n=9)
29.44
(26.72 to 32.17)
Day 1 (Cycle 20) (n=10)
29.80
(27.87 to 31.73)
Day 1 (Cycle 21) (n=11)
29.91
(26.71 to 33.11)
Day 1 (Cycle 22) (n=10)
30.80
(27.88 to 33.72)
Day 1 (Cycle 23) (n=9)
30.22
(25.74 to 34.70)
Day 1 (Cycle 24) (n=8)
31.75
(28.76 to 34.74)
Day 1 (Cycle 25) (n=7)
31.14
(27.58 to 34.70)
Day 1 (Cycle 26) (n=7)
31.29
(27.76 to 34.82)
Day 1 (Cycle 27) (n=7)
32.00
(28.08 to 35.92)
Day 1 (Cycle 28) (n=5)
34.00
(31.37 to 36.63)
Day 1 (Cycle 29) (n=6)
33.83
(31.49 to 36.17)
Day 1 (Cycle 30) (n=6)
34.00
(30.82 to 37.18)
Day 1 (Cycle 31) (n=4)
33.75
(28.49 to 39.01)
Day 1 (Cycle 32) (n=1)
34.00 [1] 
(NA to NA)
Day 1 (Cycle 33) (n=1)
34.00 [2] 
(NA to NA)
Day 1 (Cycle 34) (n=0)
NA [3] 
(NA to NA)
Day 1 (Cycle 35) (n=1)
33.00 [2] 
(NA to NA)
Day 1 (Cycle 36) (n=1)
33.00 [2] 
(NA to NA)
Day 1 (Cycle 37) (n=1)
29.00 [2] 
(NA to NA)
Day 1 (Cycle 38) (n=1)
30.00 [2] 
(NA to NA)
at Follow Up (n=9)
25.11
(20.64 to 29.58)
[1]
95% Confidence interval (CI) was not estimable because only 1 participant was evaluable.
[2]
95% CI was not estimable because only 1 participant was evaluable.
[3]
Mean was not estimable because no participant was evaluable.
6.Secondary Outcome
Title Population Pharmacokinetics of Axitinib (AG-013736)
Hide Description Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Time Frame Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index (FKSI) Score
Hide Description FKSI is a questionnaire for FACT-Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.
Time Frame Baseline (Day 1 of Cycle 1), Day 1 of all subsequent cycles up to Cycle 38 and follow up (28 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants who received at least 1 dose of the study medication, had a baseline assessment of disease and had the correct histological cancer type. 'n' is the number of participants who completed at least one question.
Arm/Group Title Axitinib
Hide Arm/Group Description:
Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
Overall Number of Participants Analyzed 62
Mean (95% Confidence Interval)
Unit of Measure: Units on a Scale
Baseline (n=62)
44.84
(42.65 to 47.03)
Day 1 (Cycle 2) (n=52)
41.40
(39.13 to 43.67)
Day 1 (Cycle 3) (n=46)
41.62
(39.28 to 43.97)
Day 1 (Cycle 4) (n=41)
42.26
(39.55 to 44.97)
Day 1 (Cycle 5) (n=39)
42.35
(39.85 to 44.84)
Day 1 (Cycle 6) (n=33)
41.65
(38.82 to 44.49)
Day 1 (Cycle 7) (n=32)
43.77
(41.09 to 46.45)
Day 1 (Cycle 8) (n=30)
44.00
(40.75 to 47.25)
Day 1 (Cycle 9) (n=27)
44.80
(41.84 to 47.76)
Day 1 (Cycle 10) (n=19)
45.39
(41.82 to 48.95)
Day 1 (Cycle 11) (n=17)
44.14
(40.23 to 48.06)
Day 1 (Cycle 12) (n=17)
44.73
(40.79 to 48.67)
Day 1 (Cycle 13) (n=16)
46.13
(42.19 to 50.06)
Day 1 (Cycle 14) (n=15)
47.04
(43.94 to 50.14)
Day 1 (Cycle 15) (n=14)
45.93
(42.67 to 49.20)
Day 1 (Cycle 16) (n=14)
46.16
(41.96 to 50.36)
Day 1 (Cycle 17) (n=13)
48.14
(44.18 to 52.10)
Day 1 (Cycle 18) (n=12)
47.08
(42.43 to 51.72)
Day 1 (Cycle 19) (n=9)
44.98
(39.24 to 50.71)
Day 1 (Cycle 20) (n=10)
45.81
(41.41 to 50.20)
Day 1 (Cycle 21) (n=11)
47.02
(40.99 to 53.05)
Day 1 (Cycle 22) (n=10)
47.50
(42.06 to 52.94)
Day 1 (Cycle 23) (n=9)
46.30
(38.77 to 53.83)
Day 1 (Cycle 24) (n=8)
48.64
(42.38 to 54.91)
Day 1 (Cycle 25) (n=7)
49.11
(44.46 to 53.77)
Day 1 (Cycle 26) (n=7)
50.26
(45.32 to 55.19)
Day 1 (Cycle 27) (n=7)
49.82
(43.61 to 56.02)
Day 1 (Cycle 28) (n=5)
53.20
(46.55 to 59.85)
Day 1 (Cycle 29) (n=6)
52.67
(45.84 to 59.49)
Day 1 (Cycle 30) (n=6)
53.17
(46.26 to 60.08)
Day 1 (Cycle 31) (n=4)
53.00
(40.74 to 65.26)
Day 1 (Cycle 32) (n=1)
53.00 [1] 
(NA to NA)
Day 1 (Cycle 33) (n=1)
51.00 [1] 
(NA to NA)
Day 1 (Cycle 34) (n=0)
NA [2] 
(NA to NA)
Day 1 (Cycle 35) (n=1)
51.00 [1] 
(NA to NA)
Day 1 (Cycle 36) (n=1)
51.00 [1] 
(NA to NA)
Day 1 (Cycle 37) (n=1)
45.00 [1] 
(NA to NA)
Day 1 (Cycle 38) (n=1)
48.00 [1] 
(NA to NA)
At Follow Up (n=9)
38.98
(32.46 to 45.49)
[1]
95% CI was not estimable because only 1 participant was evaluable.
[2]
95% CI was not estimable because no participant was evaluable.
8.Other Pre-specified Outcome
Title Correlation of Area Under the Concentration-time Curve at Steady State (AUCss) With Confirmed Partial Response (PR)
Hide Description AUCss: pharmacokinetic parameter derived from plasma concentration versus time data using non-compartmental or population based analysis methods, computed as each participant's average total daily dose (accounting for dose reductions and any recorded missed doses) divided by population estimated posthoc individual apparent clearance (CL/F), i.e., AUCss = Daily Dose/(CL/F), where F refers to the oral bioavailability, and CL refers to the systemic clearance. PR: responses with at least 30% decrease in sum of longest dimensions of target lesions using baseline (pre-treatment) sum of longest dimensions as reference. Logistic regression with general linear model was applied to data of PR using AUCss; PR was correlated with AUCss as fold increase in odds of PR with increase in AUCss. Fold increase was calculated as exponent of product of logistic regression slope coefficient and unit change of AUCss.
Time Frame Day 1 (Pre-dose), Day 29 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants for whom both Pharmacokinetic (PK) and PR data were available were included in analysis.
Arm/Group Title Axitinib
Hide Arm/Group Description:
Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Ratio
Fold change per 1 ng*hr/mL: Cycle1 1.0028
Fold change per 100 ng*hr/mL: Cycle1 1.3300
9.Other Pre-specified Outcome
Title Relationship of Area Under the Concentration-time Curve at Steady State (AUCss) With Progression-free Survival (PFS)
Hide Description AUCss is a pharmacokinetic parameter derived from plasma concentration versus time data using non-compartmental or population based analysis methods. PFS is median time from first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Relationship of PFS versus AUCss was determined as median PFS in participants with high AUCss [AUCss greater than or equal to (>=) median AUCss] or low AUCss [AUCss less than (<) median AUCss].
Time Frame Day 1 (Pre-dose), Day 29, and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants for whom both PK and PFS data were available were included in analysis. 'n' signifies number of participants evaluable for the corresponding category.
Arm/Group Title Axitinib
Hide Arm/Group Description:
Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
Overall Number of Participants Analyzed 57
Median (Full Range)
Unit of Measure: weeks
PFS at Low AUCss: Cycle1 (n=28)
31
(24 to 80)
PFS at High AUCss: Cycle1 (n=29)
39 [1] 
(31 to NA)
[1]
Upper limit of range was not estimable due to insuffecient number of progression events.
10.Other Pre-specified Outcome
Title Relationship of Area Under the Concentration-time Curve at Steady State (AUCss) With Overall Survival (OS)
Hide Description AUCss is a pharmacokinetic parameter derived from plasma concentration versus time data using non-compartmental or population based analysis methods. OS is time in weeks from the start of study treatment to date of death due to any cause. Relationship of OS versus AUCss was determined as median OS in participants with high AUCss [AUCss >= median AUCss] or low AUCss [AUCss < median AUCss].
Time Frame Day 1 (Pre-dose), Day 29 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants for whom both PK and OS data were available were included in analysis. 'n' signifies number of participants evaluable for the corresponding category.
Arm/Group Title Axitinib
Hide Arm/Group Description:
Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
Overall Number of Participants Analyzed 57
Median (Full Range)
Unit of Measure: weeks
OS at Low AUCss: Cycle1 (n=28)
43
(36 to 72)
OS at High AUCss: Cycle1 (n=29)
88 [1] 
(73 to NA)
[1]
Upper limit of range was not estimable due to insuffecient number of progression events.
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Axitinib
Hide Arm/Group Description Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
All-Cause Mortality
Axitinib
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Axitinib
Affected / at Risk (%)
Total   39/62 (62.90%) 
Cardiac disorders   
Atrial fibrillation * 1  1/62 (1.61%) 
Atrial tachycardia * 1  1/62 (1.61%) 
Bradycardia * 1  1/62 (1.61%) 
Bundle branch block left * 1  1/62 (1.61%) 
Cardiac disorder * 1  1/62 (1.61%) 
Cardiac failure congestive * 1  2/62 (3.23%) 
Left ventricular dysfunction * 1  1/62 (1.61%) 
Myocardial ischaemia * 1  2/62 (3.23%) 
Tachycardia * 1  1/62 (1.61%) 
Gastrointestinal disorders   
Abdominal distension * 1  2/62 (3.23%) 
Abdominal pain * 1  5/62 (8.06%) 
Abdominal pain upper * 1  1/62 (1.61%) 
Diverticulum * 1  1/62 (1.61%) 
Gastrointestinal perforation * 1  1/62 (1.61%) 
Haematochezia * 1  1/62 (1.61%) 
Large intestine perforation * 1  1/62 (1.61%) 
Nausea * 1  4/62 (6.45%) 
Vomiting * 1  4/62 (6.45%) 
General disorders   
Chest pain * 1  1/62 (1.61%) 
Death * 1  1/62 (1.61%) 
Disease progression * 1  4/62 (6.45%) 
Fatigue * 1  2/62 (3.23%) 
Oedema peripheral * 1  1/62 (1.61%) 
Hepatobiliary disorders   
Hepatorenal syndrome * 1  1/62 (1.61%) 
Hyperbilirubinaemia * 1  1/62 (1.61%) 
Jaundice * 1  1/62 (1.61%) 
Infections and infestations   
Cholecystitis infective * 1  1/62 (1.61%) 
Peritoneal infection * 1  1/62 (1.61%) 
Pneumonia * 1  2/62 (3.23%) 
Wound infection * 1  1/62 (1.61%) 
Injury, poisoning and procedural complications   
Wound complication * 1  1/62 (1.61%) 
Investigations   
Blood alkaline phosphatase increased * 1  1/62 (1.61%) 
Blood creatinine increased * 1  1/62 (1.61%) 
Lipase increased * 1  1/62 (1.61%) 
Metabolism and nutrition disorders   
Dehydration * 1  6/62 (9.68%) 
Hypercalcaemia * 1  2/62 (3.23%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  2/62 (3.23%) 
Nervous system disorders   
Ataxia * 1  1/62 (1.61%) 
Cerebral haemorrhage * 1  2/62 (3.23%) 
Convulsion * 1  1/62 (1.61%) 
Dizziness * 1  1/62 (1.61%) 
Headache * 1  1/62 (1.61%) 
Lethargy * 1  2/62 (3.23%) 
Syncope * 1  2/62 (3.23%) 
Psychiatric disorders   
Agitation * 1  1/62 (1.61%) 
Confusional state * 1  2/62 (3.23%) 
Mental status changes * 1  1/62 (1.61%) 
Renal and urinary disorders   
Anuria * 1  1/62 (1.61%) 
Renal failure * 1  1/62 (1.61%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/62 (1.61%) 
Dyspnoea * 1  7/62 (11.29%) 
Pleural effusion * 1  2/62 (3.23%) 
Pleuritic pain * 1  1/62 (1.61%) 
Pneumothorax * 1  1/62 (1.61%) 
Pulmonary embolism * 1  1/62 (1.61%) 
Respiratory distress * 1  1/62 (1.61%) 
Vascular disorders   
Deep vein thrombosis * 1  1/62 (1.61%) 
Embolism arterial * 1  1/62 (1.61%) 
Hypertension * 1  3/62 (4.84%) 
Hypotension * 1  5/62 (8.06%) 
Thrombosis * 1  1/62 (1.61%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Med DRA v13.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Axitinib
Affected / at Risk (%)
Total   62/62 (100.00%) 
Blood and lymphatic system disorders   
Anaemia * 1  3/62 (4.84%) 
Polycythaemia * 1  1/62 (1.61%) 
Thrombocytopenia * 1  3/62 (4.84%) 
Cardiac disorders   
Left ventricular hypertrophy * 1  1/62 (1.61%) 
Palpitations * 1  1/62 (1.61%) 
Sinus tachycardia * 1  1/62 (1.61%) 
Tachycardia * 1  2/62 (3.23%) 
Ventricular hypokinesia * 1  1/62 (1.61%) 
Ear and labyrinth disorders   
Hypoacusis * 1  1/62 (1.61%) 
Tinnitus * 1  1/62 (1.61%) 
Endocrine disorders   
Hypothyroidism * 1  11/62 (17.74%) 
Eye disorders   
Blindness * 1  1/62 (1.61%) 
Conjunctival haemorrhage * 1  1/62 (1.61%) 
Dry eye * 1  1/62 (1.61%) 
Eye pruritus * 1  1/62 (1.61%) 
Lacrimation increased * 1  1/62 (1.61%) 
Ocular hyperaemia * 1  1/62 (1.61%) 
Scleral haemorrhage * 1  1/62 (1.61%) 
Vitreous floaters * 1  1/62 (1.61%) 
Gastrointestinal disorders   
Abdominal discomfort * 1  1/62 (1.61%) 
Abdominal distension * 1  4/62 (6.45%) 
Abdominal pain * 1  11/62 (17.74%) 
Abdominal pain lower * 1  1/62 (1.61%) 
Abdominal pain upper * 1  3/62 (4.84%) 
Anorectal discomfort * 1  1/62 (1.61%) 
Cheilitis * 1  1/62 (1.61%) 
Constipation * 1  16/62 (25.81%) 
Diarrhoea * 1  38/62 (61.29%) 
Dry mouth * 1  5/62 (8.06%) 
Dyspepsia * 1  12/62 (19.35%) 
Dysphagia * 1  2/62 (3.23%) 
Erosive oesophagitis * 1  1/62 (1.61%) 
Eructation * 1  4/62 (6.45%) 
Flatulence * 1  5/62 (8.06%) 
Gastritis * 1  1/62 (1.61%) 
Gastrointestinal haemorrhage * 1  1/62 (1.61%) 
Gastrooesophageal reflux disease * 1  3/62 (4.84%) 
Gingivitis * 1  1/62 (1.61%) 
Glossodynia * 1  3/62 (4.84%) 
Haematochezia * 1  1/62 (1.61%) 
Haemorrhoids * 1  2/62 (3.23%) 
Impaired gastric emptying * 1  1/62 (1.61%) 
Large intestinal ulcer * 1  1/62 (1.61%) 
Nausea * 1  27/62 (43.55%) 
Oral pain * 1  7/62 (11.29%) 
Proctalgia * 1  3/62 (4.84%) 
Rectal fissure * 1  1/62 (1.61%) 
Rectal haemorrhage * 1  3/62 (4.84%) 
Stomatitis * 1  11/62 (17.74%) 
Tongue ulceration * 1  1/62 (1.61%) 
Vomiting * 1  19/62 (30.65%) 
General disorders   
Asthenia * 1  1/62 (1.61%) 
Axillary pain * 1  1/62 (1.61%) 
Chest pain * 1  6/62 (9.68%) 
Chills * 1  7/62 (11.29%) 
Fatigue * 1  47/62 (75.81%) 
Hypothermia * 1  1/62 (1.61%) 
Impaired healing * 1  1/62 (1.61%) 
Influenza like illness * 1  1/62 (1.61%) 
Mucosal inflammation * 1  21/62 (33.87%) 
Non-cardiac chest pain * 1  1/62 (1.61%) 
Oedema peripheral * 1  11/62 (17.74%) 
Pain * 1  7/62 (11.29%) 
Pyrexia * 1  9/62 (14.52%) 
Suprapubic pain * 1  1/62 (1.61%) 
Temperature intolerance * 1  2/62 (3.23%) 
Hepatobiliary disorders   
Bile duct obstruction * 1  1/62 (1.61%) 
Immune system disorders   
Hypersensitivity * 1  3/62 (4.84%) 
Seasonal allergy * 1  1/62 (1.61%) 
Infections and infestations   
Abscess * 1  1/62 (1.61%) 
Bacteraemia * 1  1/62 (1.61%) 
Bronchitis * 1  2/62 (3.23%) 
Candidiasis * 1  1/62 (1.61%) 
Ear infection * 1  1/62 (1.61%) 
Folliculitis * 1  1/62 (1.61%) 
Herpes zoster * 1  1/62 (1.61%) 
Localised infection * 1  1/62 (1.61%) 
Oral candidiasis * 1  1/62 (1.61%) 
Oral fungal infection * 1  1/62 (1.61%) 
Oral infection * 1  2/62 (3.23%) 
Pharyngitis * 1  5/62 (8.06%) 
Pneumonia * 1  4/62 (6.45%) 
Rhinitis * 1  4/62 (6.45%) 
Septic shock * 1  1/62 (1.61%) 
Sinusitis * 1  5/62 (8.06%) 
Tinea pedis * 1  1/62 (1.61%) 
Tooth abscess * 1  1/62 (1.61%) 
Upper respiratory tract infection * 1  4/62 (6.45%) 
Urinary tract infection * 1  8/62 (12.90%) 
Vaginal infection * 1  1/62 (1.61%) 
Vulvovaginal mycotic infection * 1  3/62 (4.84%) 
Wound infection * 1  1/62 (1.61%) 
Injury, poisoning and procedural complications   
Contusion * 1  2/62 (3.23%) 
Gastrointestinal injury * 1  1/62 (1.61%) 
Procedural pain * 1  1/62 (1.61%) 
Splinter * 1  1/62 (1.61%) 
Investigations   
Activated partial thromboplastin time prolonged * 1  1/62 (1.61%) 
Alanine aminotransferase * 1  1/62 (1.61%) 
Alanine aminotransferase increased * 1  2/62 (3.23%) 
Aspartate aminotransferase * 1  2/62 (3.23%) 
Aspartate aminotransferase increased * 1  3/62 (4.84%) 
Blood alkaline phosphatase increased * 1  1/62 (1.61%) 
Blood amylase increased * 1  1/62 (1.61%) 
Blood bilirubin increased * 1  1/62 (1.61%) 
Blood cholesterol increased * 1  1/62 (1.61%) 
Blood creatine increased * 1  2/62 (3.23%) 
Blood creatinine increased * 1  4/62 (6.45%) 
Blood lactate dehydrogenase increased * 1  1/62 (1.61%) 
Blood triglycerides increased * 1  1/62 (1.61%) 
Breath sounds abnormal * 1  1/62 (1.61%) 
International normalised ratio * 1  1/62 (1.61%) 
International normalised ratio increased * 1  2/62 (3.23%) 
Lipase increased * 1  1/62 (1.61%) 
Urobilinogen urine increased * 1  1/62 (1.61%) 
Weight decreased * 1  19/62 (30.65%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  33/62 (53.23%) 
Dehydration * 1  8/62 (12.90%) 
Hypercalcaemia * 1  1/62 (1.61%) 
Hyperkalaemia * 1  1/62 (1.61%) 
Hyperlipasaemia * 1  1/62 (1.61%) 
Hypocalcaemia * 1  1/62 (1.61%) 
Hypokalaemia * 1  1/62 (1.61%) 
Hyponatraemia * 1  1/62 (1.61%) 
Vitamin B12 deficiency * 1  1/62 (1.61%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  16/62 (25.81%) 
Arthritis * 1  2/62 (3.23%) 
Back pain * 1  8/62 (12.90%) 
Bone pain * 1  6/62 (9.68%) 
Flank pain * 1  2/62 (3.23%) 
Groin pain * 1  2/62 (3.23%) 
Joint swelling * 1  1/62 (1.61%) 
Muscle spasms * 1  4/62 (6.45%) 
Muscle tightness * 1  1/62 (1.61%) 
Muscular weakness * 1  3/62 (4.84%) 
Musculoskeletal chest pain * 1  4/62 (6.45%) 
Musculoskeletal discomfort * 1  1/62 (1.61%) 
Musculoskeletal pain * 1  3/62 (4.84%) 
Myalgia * 1  11/62 (17.74%) 
Neck pain * 1  2/62 (3.23%) 
Pain in extremity * 1  13/62 (20.97%) 
Pain in jaw * 1  1/62 (1.61%) 
Pubic pain * 1  1/62 (1.61%) 
Nervous system disorders   
Ageusia * 1  1/62 (1.61%) 
Aphonia * 1  1/62 (1.61%) 
Balance disorder * 1  1/62 (1.61%) 
Brain mass * 1  1/62 (1.61%) 
Cognitive disorder * 1  1/62 (1.61%) 
Convulsion * 1  1/62 (1.61%) 
Dizziness * 1  11/62 (17.74%) 
Dysgeusia * 1  14/62 (22.58%) 
Extrapyramidal disorder * 1  1/62 (1.61%) 
Headache * 1  16/62 (25.81%) 
Hyperaesthesia * 1  2/62 (3.23%) 
Hypoaesthesia * 1  1/62 (1.61%) 
Neuropathy peripheral * 1  1/62 (1.61%) 
Paraesthesia * 1  6/62 (9.68%) 
Peripheral sensory neuropathy * 1  2/62 (3.23%) 
Peroneal nerve palsy * 1  2/62 (3.23%) 
Sciatica * 1  3/62 (4.84%) 
Tremor * 1  2/62 (3.23%) 
Psychiatric disorders   
Anxiety * 1  6/62 (9.68%) 
Confusional state * 1  3/62 (4.84%) 
Depression * 1  10/62 (16.13%) 
Disorientation * 1  1/62 (1.61%) 
Insomnia * 1  6/62 (9.68%) 
Renal and urinary disorders   
Bladder spasm * 1  1/62 (1.61%) 
Dysuria * 1  3/62 (4.84%) 
Glycosuria * 1  1/62 (1.61%) 
Haematuria * 1  1/62 (1.61%) 
Micturition urgency * 1  2/62 (3.23%) 
Nocturia * 1  1/62 (1.61%) 
Pollakiuria * 1  3/62 (4.84%) 
Proteinuria * 1  8/62 (12.90%) 
Renal failure * 1  1/62 (1.61%) 
Urinary hesitation * 1  1/62 (1.61%) 
Urinary retention * 1  1/62 (1.61%) 
Reproductive system and breast disorders   
Breast oedema * 1  1/62 (1.61%) 
Erectile dysfunction * 1  1/62 (1.61%) 
Genital rash * 1  1/62 (1.61%) 
Scrotal disorder * 1  1/62 (1.61%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  17/62 (27.42%) 
Dysphonia * 1  23/62 (37.10%) 
Dyspnoea * 1  21/62 (33.87%) 
Dyspnoea exertional * 1  2/62 (3.23%) 
Epistaxis * 1  10/62 (16.13%) 
Hiccups * 1  3/62 (4.84%) 
Hypoxia * 1  1/62 (1.61%) 
Nasal congestion * 1  3/62 (4.84%) 
Oropharyngeal pain * 1  5/62 (8.06%) 
Pleural effusion * 1  1/62 (1.61%) 
Pleuritic pain * 1  1/62 (1.61%) 
Productive cough * 1  3/62 (4.84%) 
Pulmonary haemorrhage * 1  1/62 (1.61%) 
Rhinorrhoea * 1  4/62 (6.45%) 
Sinus congestion * 1  1/62 (1.61%) 
Upper-airway cough syndrome * 1  1/62 (1.61%) 
Wheezing * 1  1/62 (1.61%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  5/62 (8.06%) 
Dry skin * 1  9/62 (14.52%) 
Erythema * 1  4/62 (6.45%) 
Hair texture abnormal * 1  2/62 (3.23%) 
Hidradenitis * 1  1/62 (1.61%) 
Hyperhidrosis * 1  2/62 (3.23%) 
Hyperkeratosis * 1  4/62 (6.45%) 
Nail discolouration * 1  1/62 (1.61%) 
Night sweats * 1  4/62 (6.45%) 
Pain of skin * 1  2/62 (3.23%) 
Palmar erythema * 1  1/62 (1.61%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  21/62 (33.87%) 
Petechiae * 1  1/62 (1.61%) 
Plantar erythema * 1  1/62 (1.61%) 
Pruritus * 1  4/62 (6.45%) 
Psoriasis * 1  1/62 (1.61%) 
Rash * 1  1/62 (1.61%) 
Rosacea * 1  1/62 (1.61%) 
Skin disorder * 1  1/62 (1.61%) 
Skin exfoliation * 1  2/62 (3.23%) 
Skin reaction * 1  1/62 (1.61%) 
Skin ulcer * 1  2/62 (3.23%) 
Swelling face * 1  1/62 (1.61%) 
Surgical and medical procedures   
Wound drainage * 1  1/62 (1.61%) 
Vascular disorders   
Flushing * 1  5/62 (8.06%) 
Haemorrhage * 1  1/62 (1.61%) 
Hot flush * 1  1/62 (1.61%) 
Hypertension * 1  26/62 (41.94%) 
Hypotension * 1  7/62 (11.29%) 
Thrombosis * 1  1/62 (1.61%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Med DRA v13.1
Population pharmacokinetics was not presented, as the data was not available for the single study and data of other axitinib (AG-013736) Phase 2 studies would be pooled together in a separate report.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00282048    
Other Study ID Numbers: A4061023
First Submitted: January 23, 2006
First Posted: January 25, 2006
Results First Submitted: February 25, 2012
Results First Posted: April 3, 2012
Last Update Posted: July 31, 2012