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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
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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 ]
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2.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Baseline until disease progression or at least 1 year after the randomization of last participant ]
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3.  Secondary:   Percentage of Participants With Objective Response (OR)   [ Time Frame: Baseline, every 8 weeks until tumor progression or death ]
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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 ]
  Show Outcome Measure 7

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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  More Information
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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


No publications provided by Pfizer

Publications automatically indexed to this study:


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