Text Size

Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Renal Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00076011
First received: January 12, 2004
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
Results First Received: February 25, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Kidney Neoplasms
Intervention: Drug: Vascular Endothelial Growth Factor Receptor [VEGFR] and Platelet-Derived Growth Factor Receptor [PDGFR] inhibitor

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Axitinib Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.

Participant Flow:   Overall Study
    Axitinib  
STARTED     52  
COMPLETED     0  
NOT COMPLETED     52  
Death                 1  
Adverse Event                 10  
Lack of Efficacy                 25  
Withdrawal by Subject                 1  
Study terminated by sponsor                 3  
Unspecified                 11  
Ongoing                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Axitinib Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.

Baseline Measures
    Axitinib  
Number of Participants  
[units: participants]
 		  52  
Age  
[units: Years]
Mean ± Standard Deviation 		  58.8  ± 11.25  
Gender  
[units: Participants]
 		 
Female     12  
Male     40  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Percentage of Participants With Objective Response (OR)   [ Time Frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks ]

Measure Type Primary
Measure Title Percentage of Participants With Objective Response (OR)
Measure 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 response. 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 longest dimensions.
Time Frame Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Study Population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.

Reporting Groups
  Description
Axitinib Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.

Measured Values
    Axitinib  
Number of Participants Analyzed  
[units: participants]
 		  52  
Percentage of Participants With Objective Response (OR)  
[units: Percentage of participants]
Number ( 95% Confidence Interval ) 		  44.2  
  ( 30.5 to 58.7 )  

No statistical analysis provided for Percentage of Participants With Objective Response (OR)



2.  Secondary:   Time to Disease Progression (TTP)   [ Time Frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks ]

Measure Type Secondary
Measure Title Time to Disease Progression (TTP)
Measure Description Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP 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]).
Time Frame Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Study population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.

Reporting Groups
  Description
Axitinib Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.

Measured Values
    Axitinib  
Number of Participants Analyzed  
[units: participants]
 		  52  
Time to Disease Progression (TTP)  
[units: Days]
Median ( 95% Confidence Interval ) 		  477.0  
  ( 255.0 to 712.0 )  

No statistical analysis provided for Time to Disease Progression (TTP)



3.  Secondary:   Duration of Response (DR)   [ Time Frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks ]

Measure Type Secondary
Measure Title Duration of Response (DR)
Measure 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 until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).

Reporting Groups
  Description
Axitinib Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.

Measured Values
    Axitinib  
Number of Participants Analyzed  
[units: participants]
 		  23  
Duration of Response (DR)  
[units: Days]
Median ( 95% Confidence Interval ) 		  700.0  
  ( 635.0 to NA ) [1]
[1] The upper limit of 95% confidence interval (CI) was not estimable due to the high number of participants censored.

No statistical analysis provided for Duration of Response (DR)



4.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant ]

Measure Type Secondary
Measure Title Overall Survival (OS)
Measure 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 adverse event (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 initial dose for the last treated participant  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Study population included all participants who received at least 1 dose of study medication.

Reporting Groups
  Description
Axitinib Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.

Measured Values
    Axitinib  
Number of Participants Analyzed  
[units: participants]
 		  52  
Overall Survival (OS)  
[units: Days]
Median ( 95% Confidence Interval ) 		  911.0  
  ( 619.0 to NA ) [1]
[1] The upper limit of 95% CI was not estimable due to the high number of participants censored for survival.

No statistical analysis provided for Overall Survival (OS)



5.  Secondary:   Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score   [ Time Frame: Baseline, Days 29, 57, 113, 169, 225, 281, 337, 393, 449, 505, 561, 617, 673, 729, 785, 841, 897, 953 and follow-up visit after last dose ]

Measure Type Secondary
Measure Title Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score
Measure Description EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.
Time Frame Baseline, Days 29, 57, 113, 169, 225, 281, 337, 393, 449, 505, 561, 617, 673, 729, 785, 841, 897, 953 and follow-up visit after last dose  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Study population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease. The 'n' is signifying those participants who were evaluable for this measure at the specified time point.

Reporting Groups
  Description
Axitinib Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.

Measured Values
    Axitinib  
Number of Participants Analyzed  
[units: participants]
 		  52  
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score  
[units: Units on a scale]
Mean ± Standard Deviation 		 
Global health status: Baseline (n=52)     68.9  ± 23.05  
Global health status: Change at Day 29 (n=46)     -6.0  ± 20.54  
Global health status: Change at Day 57 (n=33)     -0.3  ± 24.60  
Global health status: Change at Day 113 (n=41)     -4.9  ± 25.82  
Global health status: Change at Day 169 (n=32)     -7.6  ± 28.58  
Global health status: Change at Day 225 (n=28)     4.8  ± 29.17  
Global health status: Change at Day 281 (n=22)     2.3  ± 24.42  
Global health status: Change at Day 337 (n=14)     -0.6  ± 26.65  
Global health status: Change at Day 393 (n=19)     5.7  ± 24.85  
Global health status: Change at Day 449 (n=16)     6.3  ± 28.30  
Global health status: Change at Day 505 (n=19)     1.8  ± 30.75  
Global health status: Change at Day 561 (n=16)     2.6  ± 31.73  
Global health status: Change at Day 617 (n=14)     -6.0  ± 34.35  
Global health status: Change at Day 673 (n=11)     5.3  ± 34.01  
Global health status: Change at Day 729 (n=11)     8.3  ± 28.87  
Global health status: Change at Day 785 (n=10)     9.2  ± 36.74  
Global health status: Change at Day 841 (n=4)     -8.3  ± 29.66  
Global health status: Change at Day 897 (n=1)     -16.7  ± NA [1]
Global health status: Change at Day 953 (n=1)     -33.3  ± NA [1]
Global health status: Change at follow-up (n=12)     -0.7  ± 17.57  
Physical functioning: Baseline (n=52 )     80.6  ± 18.84  
Physical functioning: Change at Day 29 (n=47)     -7.1  ± 16.08  
Physical functioning: Change at Day 57 (n=45)     -2.6  ± 15.24  
Physical functioning: Change at Day 113 (n=41)     -3.8  ± 15.38  
Physical functioning: Change at Day 169 (n=32)     -5.9  ± 14.07  
Physical functioning: Change at Day 225 (n=28)     -3.6  ± 17.11  
Physical functioning: Change at Day 281 (n=23)     -2.7  ± 19.25  
Physical functioning: Change at Day 337 (n=14)     -1.0  ± 18.09  
Physical functioning: Change at Day 393 (n=19)     1.8  ± 12.93  
Physical functioning: Change at Day 449 (n=17)     -3.0  ± 18.45  
Physical functioning: Change at Day 505 (n=20)     -3.0  ± 18.29  
Physical functioning: Change at Day 561 (n=17)     -6.3  ± 21.79  
Physical functioning: Change at Day 617 (n=14)     -3.8  ± 20.87  
Physical functioning: Change at Day 673 (n=11)     4.2  ± 15.57  
Physical functioning: Change at Day 729 (n=11)     4.2  ± 18.44  
Physical functioning: Change at Day 785 (n=10)     -3.3  ± 19.18  
Physical functioning: Change at Day 841 (n=5)     6.7  ± 16.33  
Physical functioning: Change at Day 897 (n=1)     0.0  ± NA [1]
Physical functioning: Change at Day 953 (n=1)     -33.3  ± NA [1]
Physical functioning: Change at follow-up (n=12)     -6.8  ± 17.53  
Role functioning: Baseline (n=52 )     80.4  ± 26.55  
Role functioning: Change at Day 29 (n=47)     -9.2  ± 28.62  
Role functioning: Change at Day 57 (n=45)     -8.9  ± 22.64  
Role functioning: Change at Day 113 (n=41)     -13.4  ± 32.32  
Role functioning: Change at Day 169 (n=32)     -14.6  ± 25.66  
Role functioning: Change at Day 225 (n=28)     -8.9  ± 31.26  
Role functioning: Change at Day 281 (n=23)     -5.8  ± 23.36  
Role functioning: Change at Day 337 (n=14)     -6.0  ± 19.18  
Role functioning: Change at Day 393 (n=19)     -2.6  ± 23.08  
Role functioning: Change at Day 449 (n=16)     -4.2  ± 34.69  
Role functioning: Change at Day 505 (n=20)     -6.7  ± 29.32  
Role functioning: Change at Day 561 (n=17)     -9.8  ± 32.84  
Role functioning: Change at Day 617 (n=14)     -13.1  ± 32.14  
Role functioning: Change at Day 673 (n=11)     -4.5  ± 27.98  
Role functioning: Change at Day 729 (n=11)     1.5  ± 31.14  
Role functioning: Change at Day 785 (n=10)     -6.7  ± 32.58  
Role functioning: Change at Day 841 (n=5)     10.0  ± 27.89  
Role functioning: Change at Day 897 (n=1)     0.0  ± NA [1]
Role functioning: Change at Day 953 (n=1)     -33.3  ± NA [1]
Role functioning: Change at follow-up (n=12)     -11.1  ± 22.84  
Emotional functioning: Baseline (n=52)     80.1  ± 19.40  
Emotional functioning: Change at Day 29 (n=46)     -0.4  ± 19.22  
Emotional functioning: Change at Day 57 (n=33)     3.8  ± 16.55  
Emotional functioning: Change at Day 113 (n=41)     -0.2  ± 15.08  
Emotional functioning: Change at Day 169 (n=32)     -0.3  ± 16.86  
Emotional functioning: Change at Day 225 (n=28)     6.5  ± 22.26  
Emotional functioning: Change at Day 281 (n=23)     6.5  ± 17.40  
Emotional functioning: Change at Day 337 (n=14)     11.3  ± 19.78  
Emotional functioning: Change at Day 393 (n=19)     11.0  ± 17.36  
Emotional functioning: Change at Day 449 (n=16)     7.5  ± 23.69  
Emotional functioning: Change at Day 505 (n=19)     4.4  ± 21.04  
Emotional functioning: Change at Day 561 (n=17)     7.5  ± 21.17  
Emotional functioning: Change at Day 617 (n=14)     6.5  ± 21.23  
Emotional functioning: Change at Day 673 (n=11)     9.1  ± 24.28  
Emotional functioning: Change at Day 729 (n=11)     8.3  ± 25.82  
Emotional functioning: Change at Day 785 (n=10)     4.2  ± 20.13  
Emotional functioning: Change at Day 841 (n=4)     6.3  ± 21.92  
Emotional functioning: Change at Day 897 (n=1)     25.0  ± NA [1]
Emotional functioning: Change at Day 953 (n=1)     -16.7  ± NA [1]
Emotional functioning: Change at follow-up (n=12)     -3.5  ± 20.86  
Cognitive Functioning: Baseline (n=52)     86.5  ± 16.18  
Cognitive Functioning: Change at Day 29 (n=46)     -2.5  ± 16.47  
Cognitive Functioning: Change at Day 57 (n=33)     1.0  ± 14.40  
Cognitive Functioning: Change at Day 113 (n=41)     -5.3  ± 15.11  
Cognitive Functioning: Change at Day 169 (n=32)     -7.8  ± 15.25  
Cognitive Functioning: Change at Day 225 (n=28)     -6.5  ± 19.95  
Cognitive Functioning: Change at Day 281 (n=23)     -2.2  ± 14.48  
Cognitive Functioning: Change at Day 337 (n=14)     0.0  ± 20.67  
Cognitive Functioning: Change at Day 393 (n=19)     0.9  ± 17.10  
Cognitive Functioning: Change at Day 449 (n=16)     0.0  ± 19.25  
Cognitive Functioning: Change at Day 505 (n=19)     -0.9  ± 15.19  
Cognitive Functioning: Change at Day 561 (n=17)     -1.0  ± 19.07  
Cognitive Functioning: Change at Day 617 (n=14)     -4.8  ± 18.98  
Cognitive Functioning: Change at Day 673 (n=11)     1.5  ± 21.67  
Cognitive Functioning: Change at Day 729 (n=11)     3.0  ± 22.13  
Cognitive Functioning: Change at Day 785 (n=10)     0.0  ± 17.57  
Cognitive Functioning: Change at Day 841 (n=4)     0.0  ± 27.22  
Cognitive Functioning: Change at Day 897 (n=1)     0.0  ± NA [1]
Cognitive Functioning: Change at Day 953 (n=1)     0.0  ± NA [1]
Cognitive Functioning: Change at follow-up (n=12)     -4.2  ± 16.09  
Social functioning: Baseline (n=52)     81.7  ± 26.46  
Social functioning: Change at Day 29 (n=46)     -8.7  ± 29.97  
Social functioning: Change at Day 57 (n=33)     -3.0  ± 31.31  
Social functioning: Change at Day 113 (n=41)     -6.1  ± 27.07  
Social functioning: Change at Day 169 (n=32)     -9.4  ± 31.09  
Social functioning: Change at Day 225 (n=28)     -1.2  ± 38.74  
Social functioning: Change at Day 281 (n=23)     4.3  ± 28.08  
Social functioning: Change at Day 337 (n=14)     -0.0  ± 35.20  
Social functioning: Change at Day 393 (n=19)     1.8  ± 26.58  
Social functioning: Change at Day 449 (n=16)     -3.1  ± 30.56  
Social functioning: Change at Day 505 (n=19)     -3.5  ± 35.82  
Social functioning: Change at Day 561 (n=17)     -6.9  ± 33.88  
Social functioning: Change at Day 617 (n=14)     -9.5  ± 32.50  
Social functioning: Change at Day 673 (n=11)     4.5  ± 35.03  
Social functioning: Change at Day 729 (n=11)     4.5  ± 36.58  
Social functioning: Change at Day 785 (n=10)     1.7  ± 36.39  
Social functioning: Change at Day 841 (n=4)     4.2  ± 20.97  
Social functioning: Change at Day 897 (n=1)     0.0  ± NA [1]
Social functioning: Change at Day 953 (n=1)     -66.7  ± NA [1]
Social functioning: Change at follow-up (n=12)     -2.8  ± 23.39  
Fatigue: Baseline (n=52)     27.4  ± 23.64  
Fatigue: Change at Day 29 (n=47)     11.8  ± 24.54  
Fatigue: Change at Day 57 (n=45)     7.2  ± 22.27  
Fatigue: Change at Day 113 (n=41)     7.2  ± 22.58  
Fatigue: Change at Day 169 (n=32)     6.9  ± 18.24  
Fatigue: Change at Day 225 (n=28)     3.8  ± 28.37  
Fatigue: Change at Day 281 (n=23)     1.9  ± 24.31  
Fatigue: Change at Day 337 (n=14)     3.2  ± 24.82  
Fatigue: Change at Day 393 (n=19)     -4.1  ± 22.59  
Fatigue: Change at Day 449 (n=17)     -0.0  ± 26.64  
Fatigue: Change at Day 505 (n=20)     4.7  ± 25.44  
Fatigue: Change at Day 561 (n=17)     3.3  ± 26.28  
Fatigue: Change at Day 617 (n=14)     8.3  ± 24.92  
Fatigue: Change at Day 673 (n=11)     -3.0  ± 25.38  
Fatigue: Change at Day 729 (n=11)     -4.0  ± 27.79  
Fatigue: Change at Day 785 (n=10)     -1.1  ± 30.74  
Fatigue: Change at Day 841 (n=5)     2.2  ± 21.37  
Fatigue: Change at Day 897 (n=1)     0.0  ± NA [1]
Fatigue: Change at Day 953 (n=1)     66.7  ± NA [1]
Fatigue: Change at Follow-up (n=12)     5.6  ± 19.82  
Nausea and vomiting: Baseline (n=52)     4.8  ± 12.93  
Nausea and vomiting: Change at Day 29 (n=47)     1.4  ± 14.67  
Nausea and vomiting: Change at Day 57 (n=45)     4.1  ± 16.34  
Nausea and vomiting: Change at Day 113 (n=41)     10.2  ± 19.32  
Nausea and vomiting: Change at Day 169 (n=32)     1.0  ± 15.80  
Nausea and vomiting: Change at Day 225 (n=28)     1.2  ± 16.93  
Nausea and vomiting: Change at Day 281 (n=23)     -0.7  ± 15.47  
Nausea and vomiting: Change at Day 337 (n=14)     1.2  ± 23.99  
Nausea and vomiting: Change at Day 393 (n=19)     1.8  ± 22.15  
Nausea and vomiting: Change at Day 449 (n=17)     5.9  ± 22.78  
Nausea and vomiting: Change at Day 505 (n=20)     1.7  ± 17.85  
Nausea and vomiting: Change at Day 561 (n=17)     4.9  ± 22.64  
Nausea and vomiting: Change at Day 617 (n=14)     11.9  ± 15.23  
Nausea and vomiting: Change at Day 673 (n=11)     6.1  ± 30.07  
Nausea and vomiting: Change at Day 729 (n=11)     0.0  ± 24.72  
Nausea and vomiting: Change at Day 785 (n=10)     -1.7  ± 26.59  
Nausea and vomiting: Change at Day 841 (n=5)     6.7  ± 9.13  
Nausea and vomiting: Change at Day 897 (n=1)     0.0  ± NA [1]
Nausea and vomiting: Change at Day 953 (n=1)     0.0  ± NA [1]
Nausea and vomiting: Change at follow-up (n=12)     1.4  ± 11.14  
Pain: Baseline (n=52)     22.1  ± 23.04  
Pain: Change at Day 29 (n=47)     10.3  ± 22.40  
Pain: Change at Day 57 (n=45)     5.9  ± 26.39  
Pain: Change at Day 113 (n=42)     6.7  ± 25.25  
Pain: Change at Day 169 (n=32)     5.2  ± 29.77  
Pain: Change at Day 225 (n=29)     6.9  ± 35.50  
Pain: Change at Day 281 (n=23)     0.7  ± 34.26  
Pain: Change at Day 337 (n=14)     -0.0  ± 26.95  
Pain: Change at Day 393 (n=19)     -7.0  ± 27.95  
Pain: Change at Day 449 (n=17)     -3.9  ± 27.97  
Pain: Change at Day 505 (n=20)     6.7  ± 32.17  
Pain: Change at Day 561 (n=17)     1.0  ± 32.53  
Pain: Change at Day 617 (n=14)     3.6  ± 25.47  
Pain: Change at Day 673 (n=11)     -3.0  ± 37.87  
Pain: Change at Day 729 (n=11)     -1.5  ± 32.88  
Pain: Change at Day 785 (n=10)     3.3  ± 33.15  
Pain: Change at Day 841 (n=5)     -3.3  ± 24.72  
Pain: Change at Day 897 (n=1)     0.0  ± NA [1]
Pain: Change at Day 953 (n=1)     33.3  ± NA [1]
Pain: Change at follow-up (n=12)     8.3  ± 33.71  
Dyspnea: Baseline (n=52)     18.6  ± 24.18  
Dyspnea: Change at Day 29 (n=47)     -0.7  ± 23.56  
Dyspnea: Change at Day 57 (n=45)     -0.7  ± 19.45  
Dyspnea: Change at Day 113 (n=41)     -1.6  ± 18.18  
Dyspnea: Change at Day 169 (n=32)     -3.1  ± 22.97  
Dyspnea: Change at Day 225 (n=28)     2.4  ± 29.99  
Dyspnea: Change at Day 281 (n=23)     0.0  ± 31.78  
Dyspnea: Change at Day 337 (n=14)     -7.1  ± 32.50  
Dyspnea: Change at Day 393 (n=19)     -5.3  ± 20.07  
Dyspnea: Change at Day 449 (n=17)     -5.9  ± 24.25  
Dyspnea: Change at Day 505 (n=20)     1.7  ± 29.57  
Dyspnea: Change at Day 561 (n=17)     0.0  ± 26.35  
Dyspnea: Change at Day 617 (n=14)     4.8  ± 31.64  
Dyspnea: Change at Day 673 (n=11)     -6.1  ± 32.72  
Dyspnea: Change at Day 729 (n=11)     -3.0  ± 27.71  
Dyspnea: Change at Day 785 (n=10)     3.3  ± 24.60  
Dyspnea: Change at Day 841 (n=5)     0.0  ± 23.57  
Dyspnea: Change at Day 897 (n=1)     0.0  ± NA [1]
Dyspnea: Change at Day 953 (n=1)     33.3  ± NA [1]
Dyspnea: Change at follow-up (n=12)     -2.8  ± 22.29  
Insomnia: Baseline (n=51)     23.5  ± 30.03  
Insomnia: Change at Day 29 (n=46)     -1.4  ± 30.60  
Insomnia: Change at Day 57 (n=45)     -2.2  ± 30.48  
Insomnia: Change at Day 113 (n=41)     -3.3  ± 28.68  
Insomnia: Change at Day 169 (n=32)     -2.1  ± 31.61  
Insomnia: Change at Day 225 (n=28)     -4.8  ± 38.18  
Insomnia: Change at Day 281 (n=23)     0.0  ± 36.24  
Insomnia: Change at Day 337 (n=14)     -7.1  ± 37.39  
Insomnia: Change at Day 393 (n=19)     -7.0  ± 36.14  
Insomnia: Change at Day 449 (n=17)     -2.0  ± 32.21  
Insomnia: Change at Day 505 (n=20)     -5.0  ± 31.11  
Insomnia: Change at Day 561 (n=17)     -9.8  ± 36.83  
Insomnia: Change at Day 617 (n=14)     -4.8  ± 34.24  
Insomnia: Change at Day 673 (n=11)     -3.0  ± 43.34  
Insomnia: Change at Day 729 (n=11)     -12.1  ± 34.23  
Insomnia: Change at Day 785 (n=10)     -13.3  ± 39.13  
Insomnia: Change at Day 841 (n=5)     -13.3  ± 50.55  
Insomnia: Change at Day 897 (n=1)     0.0  ± NA [1]
Insomnia: Change at Day 953 (n=1)     33.3  ± NA [1]
Insomnia: Change at follow-up (n=11)     -3.0  ± 23.35  
Loss of appetite: Baseline (n=52)     12.8  ± 25.70  
Loss of appetite: Change at Day 29 (n=47)     7.1  ± 31.80  
Loss of appetite: Change at Day 57 (n=45)     5.9  ± 33.55  
Loss of appetite: Change at Day 113 (n=41)     15.4  ± 34.24  
Loss of appetite: Change at Day 169 (n=32)     5.2  ± 35.02  
Loss of appetite: Change at Day 225 (n=28)     4.8  ± 38.18  
Loss of appetite: Change at Day 281 (n=22)     1.5  ± 31.67  
Loss of appetite: Change at Day 337 (n=14)     -2.4  ± 42.29  
Loss of appetite: Change at Day 393 (n=19)     5.3  ± 35.60  
Loss of appetite: Change at Day 449 (n=17)     2.0  ± 36.27  
Loss of appetite: Change at Day 505 (n=20)     -0.0  ± 34.20  
Loss of appetite: Change at Day 561 (n=17)     2.0  ± 36.27  
Loss of appetite: Change at Day 617 (n=14)     9.5  ± 20.37  
Loss of appetite: Change at Day 673 (n=11)     -3.0  ± 43.34  
Loss of appetite: Change at Day 729 (n=11)     -6.1  ± 35.96  
Loss of appetite: Change at Day 785 (n=10)     -13.3  ± 42.16  
Loss of appetite: Change at Day 841 (n=5)     6.7  ± 43.46  
Loss of appetite: Change at Day 897 (n=1)     0.0  ± NA [1]
Loss of appetite: Change at Day 953 (n=1)     0.0  ± NA [1]
Loss of appetite: Change at follow-up (n=12)     8.3  ± 25.13  
Constipation: Baseline (n=52)     13.5  ± 22.15  
Constipation: Change at Day 29 (n=47)     5.0  ± 16.99  
Constipation: Change at Day 57 (n=45)     3.0  ± 17.15  
Constipation: Change at Day 113 (n=41)     4.1  ± 27.08  
Constipation: Change at Day 169 (n=32)     2.1  ± 28.00  
Constipation: Change at Day 225 (n=28)     0.0  ± 25.66  
Constipation: Change at Day 281 (n=23)     2.9  ± 22.28  
Constipation: Change at Day 337 (n=14)     4.8  ± 25.68  
Constipation: Change at Day 393 (n=18)     -7.4  ± 21.56  
Constipation: Change at Day 449 (n=17)     0.0  ± 26.35  
Constipation: Change at Day 505 (n=20)     5.0  ± 29.17  
Constipation: Change at Day 561 (n=17)     0.0  ± 23.57  
Constipation: Change at Day 617 (n=14)     -4.8  ± 17.82  
Constipation: Change at Day 673 (n=11)     -6.1  ± 20.10  
Constipation: Change at Day 729 (n=11)     -3.0  ± 10.05  
Constipation: Change at Day 785 (n=10)     -3.3  ± 18.92  
Constipation: Change at Day 841 (n=5)     -6.7  ± 14.91  
Constipation: Change at Day 897 (n=1)     0.0  ± NA [1]
Constipation: Change at Day 953 (n=1)     0.0  ± NA [1]
Constipation: Change at follow-up (n=12)     2.8  ± 22.29  
Diarrhea: Baseline (n=52)     8.3  ± 20.74  
Diarrhea: Change at Day 29 (n=47)     1.4  ± 16.96  
Diarrhea: Change at Day 57 (n=45)     5.9  ± 21.66  
Diarrhea: Change at Day 113 (n=41)     17.9  ± 28.96  
Diarrhea: Change at Day 169 (n=32)     16.7  ± 38.80  
Diarrhea: Change at Day 225 (n=28)     20.2  ± 26.20  
Diarrhea: Change at Day 281 (n=23)     29.0  ± 28.96  
Diarrhea: Change at Day 337 (n=14)     42.9  ± 33.15  
Diarrhea: Change at Day 393 (n=19)     33.3  ± 33.33  
Diarrhea: Change at Day 449 (n=17)     23.5  ± 25.72  
Diarrhea: Change at Day 505 (n=20)     35.0  ± 35.00  
Diarrhea: Change at Day 561 (n=17)     31.4  ± 27.56  
Diarrhea: Change at Day 617 (n=14)     40.5  ± 26.73  
Diarrhea: Change at Day 673 (n=11)     36.4  ± 37.87  
Diarrhea: Change at Day 729 (n=11)     27.3  ± 32.72  
Diarrhea: Change at Day 785 (n=10)     16.7  ± 17.57  
Diarrhea: Change at Day 841 (n=5)     20.0  ± 18.26  
Diarrhea: Change at Day 897 (n=1)     0.0  ± NA [1]
Diarrhea: Change at Day 953 (n=1)     0.0  ± NA [1]
Diarrhea: Change at follow-up (n=12)     -11.1  ± 25.95  
Financial difficulties: Baseline (n=51)     15.0  ± 26.09  
Financial difficulties: Change at Day 29 (n=45)     -3.0  ± 24.44  
Financial difficulties: Change at Day 57 (n=33)     -8.1  ± 26.39  
Financial difficulties: Change at Day 113 (n=41)     -5.7  ± 23.45  
Financial difficulties: Change at Day 169 (n=32)     -3.1  ± 13.01  
Financial difficulties: Change at Day 225 (n=28)     1.2  ± 32.05  
Financial difficulties: Change at Day 281 (n=23)     1.4  ± 15.82  
Financial difficulties: Change at Day 337 (n=14)     0.0  ± 18.49  
Financial difficulties: Change at Day 393 (n=19)     -1.8  ± 20.71  
Financial difficulties: Change at Day 449 (n=16)     2.1  ± 22.67  
Financial difficulties: Change at Day 505 (n=19)     -1.8  ± 20.71  
Financial difficulties: Change at Day 561 (n=17)     -2.0  ± 29.98  
Financial difficulties: Change at Day 617 (n=14)     0.0  ± 29.24  
Financial difficulties: Change at Day 673 (n=11)     -6.1  ± 29.13  
Financial difficulties: Change at Day 729 (n=11)     -6.1  ± 25.03  
Financial difficulties: Change at Day 785 (n=10)     10.0  ± 31.62  
Financial difficulties: Change at Day 841 (n=4)     8.3  ± 16.67  
Financial difficulties: Change at Day 897 (n=1)     0.0  ± NA [1]
Financial difficulties: Change at Day 953 (n=1)     0.0  ± NA [1]
Financial difficulties: Change at follow-up (n=12)     0.0  ± 14.21  
[1] Standard deviation was not estimable since only 1 participant was evaluable.

No statistical analysis provided for Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score



6.  Other Pre-specified:   Population Pharmacokinetics of Axitinib (AG-013736)   [ Time Frame: Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks up to 139 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00076011     History of Changes
Obsolete Identifiers: NCT00077272
Other Study ID Numbers: A4061012
Study First Received: January 12, 2004
Results First Received: February 25, 2012
Last Updated: June 20, 2012
Health Authority: United States: Food and Drug Administration