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Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00471146
First received: May 7, 2007
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
Results First Received: February 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Carcinoma, Pancreatic Ductal
Interventions: Drug: AG-013736
Drug: Gemcitabine
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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 + Gemcitabine Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) in cycles of 4 weeks. Gemcitabine 1000 mg per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Participant Flow:   Overall Study
    Axitinib + Gemcitabine     Placebo + Gemcitabine  
STARTED     314     316  
Treated     305     308  
COMPLETED     142     142  
NOT COMPLETED     172     174  
Adverse Event                 32                 33  
Withdrawal by Subject                 14                 11  
Death                 11                 12  
Lost to Follow-up                 4                 2  
Protocol Violation                 2                 2  
Objective progression or relapse                 84                 87  
Global deterioration of health status                 12                 14  
Randomized but not treated                 9                 8  
Unspecified                 4                 5  



  Baseline Characteristics
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Reporting Groups
  Description
Axitinib + Gemcitabine Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Total Total of all reporting groups

Baseline Measures
    Axitinib + Gemcitabine     Placebo + Gemcitabine     Total  
Number of Participants  
[units: participants]
 		  314     316     630  
Age, Customized  
[units: Participants]
 		     
Less than 65 years     203     179     382  
Greater than or equal to 65 years     111     137     248  
Gender  
[units: Participants]
 		     
Female     123     128     251  
Male     191     188     379  



  Outcome Measures
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1.  Primary:   Overall Survival (OS)   [ Time Frame: Baseline until death or at least 1 year after the randomization of last participant ]
  Show Outcome Measure 1

2.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Baseline until disease progression or at least 1 year after the randomization of last participant ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants With Objective Response (OR)   [ Time Frame: Baseline, every 8 weeks until tumor progression or death ]
  Show Outcome Measure 3

4.  Secondary:   Duration of Response (DR)   [ Time Frame: Baseline until death or at least 1 year after the randomization of last participant ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score   [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score   [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score   [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]
  Hide Outcome Measure 7

Measure Type Secondary
Measure Title Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score
Measure Description BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; ‘0=No pain and 10=Pain as bad as you can imagine’. Measure can be scored by item, with lower scores being indicative of less pain or pain interference.
Time Frame Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal  
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.
ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Reporting Groups
  Description
Axitinib + Gemcitabine Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Measured Values
    Axitinib + Gemcitabine     Placebo + Gemcitabine  
Number of Participants Analyzed  
[units: participants]
 		  314     316  
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score  
[units: Units on a scale]
Mean ± Standard Deviation 		   
Worst Pain: Baseline (n=247, 250)     3.8  ± 2.84     3.7  ± 2.96  
Worst Pain: Change at C2 D1 (n=192, 200)     -0.7  ± 3.04     -0.9  ± 2.84  
Worst Pain: Change at C3 D1 (n=138, 151)     -1.5  ± 3.09     -0.9  ± 2.83  
Worst Pain: Change at C4 D1 (n=99, 113)     -1.0  ± 3.41     -0.9  ± 3.09  
Worst Pain: Change at C5 D1 (n=69, 64)     -1.1  ± 3.43     -1.2  ± 3.08  
Worst Pain: Change at C6 D1 (n=41, 43)     -0.9  ± 2.98     -1.0  ± 3.17  
Worst Pain: Change at C7 D1 (n=25, 26)     -0.8  ± 2.27     -0.9  ± 3.50  
Worst Pain: Change at C8 D1 (n=12, 13)     0.8  ± 2.56     -1.5  ± 3.20  
Worst Pain: Change at C9 D1(n=6, 6)     -1.8  ± 1.94     -1.3  ± 1.51  
Worst Pain: Change at C10 D1 (n=2, 3)     -2.0  ± 2.83     -0.3  ± 2.31  
Worst Pain: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   0.0  ± NA [1]
Worst Pain: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Worst Pain: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -4.0  ± NA [1]
Worst Pain: Change at follow-up (n=47, 46)     0.5  ± 3.08     0.0  ± 3.21  
Pain in Last 24 Hours (hrs): Baseline (n=246, 248)     1.8  ± 1.92     1.7  ± 1.93  
Pain in Last 24 hrs: Change at C2 D1 (n=193, 197)     -0.2  ± 2.21     -0.3  ± 1.92  
Pain in Last 24 hrs: Change at C3 D1 (n=138, 150)     -0.6  ± 2.01     -0.3  ± 1.88  
Pain in Last 24 hrs: Change at C4 D1 (n=99, 112)     -0.3  ± 2.15     -0.0  ± 1.96  
Pain in Last 24 hrs: Change at C5 D1 (n=69, 63)     -0.3  ± 2.41     -0.2  ± 2.04  
Pain in Last 24 hrs: Change at C6 D1 (n=40, 43)     -0.2  ± 2.07     -0.1  ± 1.64  
Pain in Last 24 hrs: Change at C7 D1 (n=25, 26)     0.4  ± 1.47     -0.0  ± 2.46  
Pain in Last 24 hrs: Change at C8 D1 (n=12, 13)     1.3  ± 2.34     -0.2  ± 1.41  
Pain in Last 24 hrs: Change at C9 D1 (n=6, 6)     -0.3  ± 1.37     0.2  ± 1.60  
Pain in Last 24 hrs: Change at C10 D1 (n=2, 3)     -1.5  ± 2.12     0.3  ± 0.58  
Pain in Last 24 hrs: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   4.0  ± NA [1]
Pain in Last 24 hrs: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Pain in Last 24 hrs: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -1.0  ± NA [1]
Pain in Last 24 hrs: Change at followup (n=48, 45)     0.4  ± 2.70     0.8  ± 2.58  
Pain on the Average: Baseline (n=246, 248)     2.9  ± 2.16     2.8  ± 2.27  
Pain on the Average: Change at C2 D1 (n=195, 198)     -0.5  ± 2.02     -0.5  ± 2.29  
Pain on the Average: Change at C3 D1 (n=140, 149)     -0.8  ± 2.48     -0.5  ± 2.10  
Pain on the Average: Change at C4 D1 (n=99, 113)     -0.7  ± 2.44     -0.6  ± 2.03  
Pain on the Average: Change at C5 D1 (n=69, 63)     -0.7  ± 2.48     -0.6  ± 2.29  
Pain on the Average: Change at C6 D1 (n=40, 43)     -0.5  ± 2.07     -0.9  ± 2.12  
Pain on the Average: Change at C7 D1 (n=25, 26)     -0.3  ± 1.46     -0.5  ± 2.97  
Pain on the Average: Change at C8 D1 (n=12, 13)     1.0  ± 2.00     -1.4  ± 1.94  
Pain on the Average: Change at C9 D1 (n=6, 6)     -1.7  ± 1.51     -1.7  ± 1.86  
Pain on the Average: Change at C10 D1 (n=2, 3)     -2.0  ± 2.83     -1.0  ± 2.65  
Pain on the Average: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   -3.0  ± NA [1]
Pain on the Average: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Pain on the Average: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -2.0  ± NA [1]
Pain on the Average: Change at followup (n=48, 45)     0.6  ± 2.70     0.4  ± 2.74  
Pain Right Now: Baseline (n=248, 249)     2.1  ± 2.13     2.1  ± 2.36  
Pain Right Now: Change at C2 D1 (n=196, 200)     -0.4  ± 2.23     -0.5  ± 2.37  
Pain Right Now: Change at C3 D1 (n=140, 150)     -0.8  ± 2.31     -0.6  ± 2.06  
Pain Right Now: Change at C4 D1 (n=99, 113)     -0.6  ± 2.26     -0.5  ± 2.45  
Pain Right Now: Change at C5 D1 (n=68, 63)     -0.5  ± 2.76     -0.3  ± 2.65  
Pain Right Now: Change at C6 D1 (n=40, 43)     -0.5  ± 1.96     -0.5  ± 2.14  
Pain Right Now: Change at C7 D1 (n=25, 26)     0.1  ± 1.66     -0.2  ± 3.26  
Pain Right Now: Change at C8 D1 (n=12, 13)     1.1  ± 1.93     -0.6  ± 1.56  
Pain Right Now: Change at C9 D1 (n=6, 6)     -1.5  ± 1.76     -0.3  ± 0.52  
Pain Right Now: Change at C10 D1 (n=2, 3)     -2.0  ± 2.83     0.7  ± 1.15  
Pain Right Now: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   5.0  ± NA [1]
Pain Right Now: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Pain Right Now: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -5.0  ± NA [1]
Pain Right Now: Change at follow-up (n=48, 46)     0.4  ± 2.64     -0.0  ± 2.67  
Relief Pain Treatment (Tx): Baseline (n=226, 221)     7.8  ± 12.09     6.9  ± 9.71  
Relief Pain Tx: Change at C2 D1 (n=164, 165)     0.6  ± 13.96     0.4  ± 11.48  
Relief Pain Tx: Change at C3 D1 (n=122, 124)     -2.1  ± 13.10     0.1  ± 9.16  
Relief Pain Tx: Change at C4 D1 (n=88, 92)     -1.7  ± 13.51     -0.9  ± 17.56  
Relief Pain Tx: Change at C5 D1 (n=59, 51)     -2.9  ± 16.35     1.8  ± 11.62  
Relief Pain Tx: Change at C6 D1 (n=34, 33)     -1.6  ± 11.90     0.5  ± 4.28  
Relief Pain Tx: Change at C7 D1 (n=21, 18)     1.0  ± 2.78     -3.2  ± 19.65  
Relief Pain Tx: Change at C8 D1 (n=10, 8)     -5.0  ± 21.20     -11.6  ± 28.16  
Relief Pain Tx: Change at C9 D1 (n=5, 5)     -14.0  ± 28.99     -16.6  ± 35.44  
Relief Pain Tx: Change at C10 D1 (n=1, 2)     6.0  ± NA [1]   0.0  ± 1.41  
Relief Pain Tx: Change at C11 D1 (n=0, 1)     NA  ± NA [2]   0.0  ± NA [1]
Relief Pain Tx: Change at C12 D1 (n=0, 0)     NA  ± NA [2]   NA  ± NA [2]
Relief Pain Tx: Change at C13 D1 (n=0, 0)     NA  ± NA [2]   NA  ± NA [2]
Relief Pain Tx: Change at follow-up (n=43, 36)     0.2  ± 3.82     -0.4  ± 5.08  
General Activity: Baseline (n=243, 243)     3.2  ± 3.11     3.0  ± 3.01  
General Activity: Change at C2 D1 (n=190, 193)     -0.6  ± 2.96     -0.7  ± 2.55  
General Activity: Change at C3 D1 (n=135, 143)     -1.1  ± 3.47     -0.7  ± 2.61  
General Activity: Change at C4 D1 (n=97, 109)     -0.4  ± 3.10     -0.8  ± 2.53  
General Activity: Change at C5 D1 (n=66, 62)     -0.8  ± 3.64     -0.5  ± 2.51  
General Activity: Change at C6 D1 (n=40, 41)     -0.6  ± 3.82     -0.7  ± 2.62  
General Activity: Change at C7 D1 (n=25, 25)     -0.5  ± 2.87     -0.4  ± 2.84  
General Activity: Change at C8 D1 (n=12, 12)     0.1  ± 2.07     -0.8  ± 2.70  
General Activity: Change at C9 D1 (n=6, 6)     -2.2  ± 2.71     0.3  ± 3.72  
General Activity: Change at C10 D1 (n=2, 3)     -2.5  ± 3.54     3.0  ± 5.29  
General Activity: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   1.0  ± NA [1]
General Activity: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
General Activity: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -1.0  ± NA [1]
General Activity: Change at follow-up (n=47, 44)     1.0  ± 4.32     0.0  ± 3.63  
Mood: Baseline (n=243, 241)     3.0  ± 2.92     2.8  ± 2.77  
Mood: Change at C2 D1 (n=191, 191)     -0.6  ± 2.74     -0.2  ± 2.46  
Mood: Change at C3 D1 (n=135, 141)     -1.0  ± 3.39     -0.5  ± 2.51  
Mood: Change at C4 D1 (n=98, 106)     -0.3  ± 3.22     -0.9  ± 2.81  
Mood: Change at C5 D1 (n=66, 61)     -0.7  ± 3.66     -0.9  ± 2.59  
Mood: Change at C6 D1 (n=40, 41)     -0.6  ± 3.23     -0.8  ± 2.93  
Mood: Change at C7 D1 (n=25, 25)     0.0  ± 2.54     -0.2  ± 3.18  
Mood: Change at C8 D1 (n=12, 12)     0.6  ± 1.31     -1.1  ± 3.12  
Mood: Change at C9 D1 (n=6, 6)     -1.3  ± 1.97     -0.8  ± 3.31  
Mood: Change at C10 D1 (n=2, 3)     -1.0  ± 1.41     3.3  ± 1.53  
Mood: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   5.0  ± NA [1]
Mood: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Mood: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -3.0  ± NA [1]
Mood: Change at follow-up (n=47, 44)     0.9  ± 3.65     0.2  ± 3.62  
Walking Ability: Baseline (n=242, 243)     2.2  ± 2.78     2.3  ± 2.81  
Walking Ability: Change at C2 D1 (n=189, 194)     0.1  ± 2.84     -0.1  ± 2.61  
Walking Ability: Change at C3 D1 (n=133, 143)     -0.2  ± 3.41     -0.3  ± 2.52  
Walking Ability: Change at C4 D1 (n=97, 108)     0.3  ± 3.32     -0.4  ± 2.64  
Walking Ability: Change at C5 D1 (n=66, 62)     0.1  ± 3.49     -0.3  ± 2.37  
Walking Ability: Change at C6 D1 (n=41, 41)     0.5  ± 2.86     -0.2  ± 2.24  
Walking Ability: Change at C7 D1 (n=25, 25)     1.1  ± 2.67     -0.1  ± 2.42  
Walking Ability: Change at C8 D1 (n=12, 12)     0.7  ± 2.46     -1.3  ± 2.42  
Walking Ability: Change at C9 D1 (n=6, 6)     -1.0  ± 3.52     0.2  ± 4.62  
Walking Ability: Change at C10 D1 (n=2, 3)     -2.0  ± 2.83     1.3  ± 5.51  
Walking Ability: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   0.0  ± NA [1]
Walking Ability: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Walking Ability: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -2.0  ± NA [1]
Walking Ability: Change at follow-up (n=47, 45)     0.9  ± 4.13     0.7  ± 3.27  
Normal Work: Baseline (n=240, 240)     3.5  ± 3.34     3.2  ± 3.23  
Normal Work: Change at C2 D1 (n=187, 191)     -0.4  ± 3.24     -0.1  ± 3.16  
Normal Work: Change at C3 D1 (n=133, 139)     -0.6  ± 3.33     -0.4  ± 2.67  
Normal Work: Change at C4 D1 (n=96, 107)     -0.2  ± 3.15     -0.7  ± 2.90  
Normal Work: Change at C5 D1 (n=65, 61)     -0.7  ± 3.86     -0.6  ± 2.71  
Normal Work: Change at C6 D1 (n=39, 41)     0.2  ± 3.62     -0.2  ± 3.12  
Normal Work: Change at C7 D1 (n=25, 24)     0.5  ± 2.76     -0.4  ± 2.52  
Normal Work: Change at C8 D1 (n=12, 12)     -0.3  ± 3.70     -0.1  ± 3.37  
Normal Work: Change at C9 D1 (n=6, 6)     -1.5  ± 3.51     3.5  ± 4.32  
Normal Work: Change at C10 D1 (n=2, 3)     -0.5  ± 0.71     1.3  ± 3.51  
Normal Work: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   2.0  ± NA [1]
Normal Work: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Normal Work: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -2.0  ± NA [1]
Normal Work: Change at follow-up (n=46, 43)     1.0  ± 4.54     0.3  ± 3.90  
Relations: Baseline (n=244, 242)     2.3  ± 2.93     1.9  ± 2.44  
Relations: Change at C2 D1 (n=190, 193)     -0.3  ± 2.82     0.0  ± 2.18  
Relations: Change at C3 D1 (n=136, 142)     -0.4  ± 3.81     -0.0  ± 2.16  
Relations: Change at C4 D1 (n=98, 108)     -0.2  ± 3.36     -0.1  ± 2.52  
Relations: Change at C5 D1 (n=66, 62)     -0.6  ± 3.11     -0.1  ± 2.27  
Relations: Change at C6 D1 (n=40, 41)     -0.3  ± 4.01     -0.1  ± 2.76  
Relations: Change at C7 D1 (n=25, 25)     0.8  ± 3.32     -0.7  ± 2.44  
Relations: Change at C8 D1 (n=12, 12)     0.6  ± 2.61     -0.9  ± 2.35  
Relations: Change at C9 D1 (n=6, 6)     -1.2  ± 2.93     0.8  ± 4.88  
Relations: Change at C10 D1 (n=2, 3)     1.0  ± 1.41     2.7  ± 2.52  
Relations: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   2.0  ± NA [1]
Relations: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Relations: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -2.0  ± NA [1]
Relations: Change at follow-up (n=47, 45)     0.7  ± 3.94     0.8  ± 3.56  
Sleep: Baseline (n=244, 242)     3.3  ± 3.16     3.2  ± 3.17  
Sleep: Change at C2 D1 (n=191, 193)     -1.1  ± 3.36     -0.9  ± 2.73  
Sleep: Change at C3 D1 (n=136, 142)     -1.6  ± 3.52     -1.1  ± 2.89  
Sleep: Change at C4 D1 (n=98, 107)     -1.2  ± 3.29     -1.2  ± 3.02  
Sleep: Change at C5 D1 (n=66, 62)     -1.3  ± 4.06     -0.8  ± 3.37  
Sleep: Change at C6 D1(n=39, 41)     -1.5  ± 3.22     -0.8  ± 3.62  
Sleep: Change at C7 D1 (n=25, 25)     -0.2  ± 3.61     -0.6  ± 2.81  
Sleep: Change at C8 D1 (n=12, 12)     0.6  ± 2.71     -1.2  ± 3.51  
Sleep: Change at C9 D1 (n=6, 6)     -2.3  ± 3.20     0.3  ± 2.07  
Sleep: Change at C10 D1 (n=2, 3)     1.0  ± 1.41     0.7  ± 3.51  
Sleep: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   4.0  ± NA [1]
Sleep: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Sleep: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -5.0  ± NA [1]
Sleep: Change at follow-up (n=47, 44)     0.5  ± 3.65     -0.3  ± 3.54  
Enjoyment of Life: Baseline (n=242, 240)     3.5  ± 3.34     3.4  ± 3.17  
Enjoyment of Life: Change at C2 D1 (n=191, 191)     -0.6  ± 2.99     -0.5  ± 2.89  
Enjoyment of Life: Change at C3 D1 (n=134, 142)     -0.7  ± 3.64     -0.7  ± 2.77  
Enjoyment of Life: Change at C4 D1 (n=98, 107)     -0.6  ± 3.58     -0.9  ± 2.70  
Enjoyment of Life: Change at C5 D1 (n=66, 62)     -0.6  ± 4.03     -0.8  ± 3.07  
Enjoyment of Life: Change at C6 D1 (n=40, 41)     -0.4  ± 3.87     -1.0  ± 3.17  
Enjoyment of Life: Change at C7 D1 (n=25, 25)     0.4  ± 3.53     -0.9  ± 2.28  
Enjoyment of Life: Change at C8 D1 (n=12, 12)     0.8  ± 2.98     -0.8  ± 2.53  
Enjoyment of Life: Change at C9 D1 (n=6, 6)     -0.5  ± 5.01     0.2  ± 2.86  
Enjoyment of Life: Change at C10 D1 (n=2, 3)     0.5  ± 0.71     2.3  ± 5.51  
Enjoyment of Life: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   -1.0  ± NA [1]
Enjoyment of Life: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Enjoyment of Life: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -4.0  ± NA [1]
Enjoyment of Life: Change at follow-up (n=47, 43)     0.2  ± 3.68     -0.2  ± 3.99  
Combined Pain Intensity(PI): Baseline (n=248, 251)     2.7  ± 1.98     2.6  ± 2.12  
Combined PI: Change at C2 D1 (n=196, 202)     -0.4  ± 1.97     -0.5  ± 1.97  
Combined PI: Change at C3 D1 (n=140, 151)     -0.9  ± 2.15     -0.6  ± 1.88  
Combined PI: Change at C4 D1 (n=99, 114)     -0.6  ± 2.19     -0.5  ± 1.99  
Combined PI: Change at C5 D1 (n=69, 64)     -0.6  ± 2.46     -0.6  ± 2.19  
Combined PI: Change at C6 D1 (n=41, 43)     -0.5  ± 1.92     -0.6  ± 1.89  
Combined PI: Change at C7 D1 (n=25, 27)     -0.1  ± 1.48     -0.4  ± 2.78  
Combined PI: Change at C8 D1 (n=12, 13)     1.0  ± 2.01     -0.9  ± 1.76  
Combined PI: Change at C9 D1 (n=6, 6)     -1.3  ± 1.51     -0.8  ± 1.11  
Combined PI: Change at C10 D1 (n=2, 3)     -1.9  ± 2.69     -0.1  ± 1.44  
Combined PI: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   1.5  ± NA [1]
Combined PI: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Combined PI: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -3.0  ± NA [1]
Combined PI:Change follow-up (n=48, 47)     0.5  ± 2.34     0.2  ± 2.56  
Combined Pain Interference(Pf):Baseline(n=244,243)     3.0  ± 2.64     2.8  ± 2.52  
Combined Pf: Change at C2 D1 (n=191, 194)     -0.5  ± 2.44     -0.4  ± 1.97  
Combined Pf: Change at C3 D1 (n=136,143)     -0.8  ± 2.99     -0.5  ± 2.01  
Combined Pf: Change at C4 D1 (n=98,109)     -0.4  ± 2.62     -0.7  ± 2.12  
Combined Pf: Change at C5 D1 (n=66, 62)     -0.6  ± 3.18     -0.6  ± 2.07  
Combined Pf: Change at C6 D1 (n=41, 41)     -0.4  ± 2.92     -0.6  ± 2.38  
Combined Pf: Change at C7 D1 (n=25, 25)     0.3  ± 2.32     -0.5  ± 2.10  
Combined Pf: Change at C8 D1 (n=12, 12)     0.4  ± 1.84     -0.9  ± 2.15  
Combined Pf: Change at C9 D1 (n=6, 6)     -1.4  ± 2.69     0.7  ± 2.86  
Combined Pf: Change at C10 D1 (n=2, 3)     -0.5  ± 0.71     2.1  ± 2.90  
Combined Pf: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   1.9  ± NA [1]
Combined Pf: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Combined Pf: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -2.7  ± NA [1]
Combined Pf: Change at follow-up (n=47, 45)     0.7  ± 3.55     0.3  ± 3.40  
[1] Standard deviation was not estimable since only one participant was evaluable.
[2] Data was not analyzed as no participants were evaluable for the particular cycle.

No statistical analysis provided for Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score



8.  Secondary:   Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile   [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score   [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]
  Show Outcome Measure 9

10.  Secondary:   Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)   [ Time Frame: Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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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
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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


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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00471146     History of Changes
Other Study ID Numbers: A4061028
Study First Received: May 7, 2007
Results First Received: February 25, 2012
Last Updated: June 14, 2012
Health Authority: United States: Food and Drug Administration