Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00735904
First received: August 13, 2008
Last updated: November 30, 2012
Last verified: November 2012
Results First Received: November 30, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung (NSCLC)
Interventions: Drug: AG-013736
Drug: gemcitabine
Drug: cisplatin

  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
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 + Cisplatin + Gemcitabine Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.

Participant Flow:   Overall Study
    Axitinib + Cisplatin + Gemcitabine  
STARTED     38  
COMPLETED     0  
NOT COMPLETED     38  
Adverse Event                 3  
Death                 20  
Protocol Violation                 1  
Withdrawal by Subject                 1  
Study Terminated by Sponsor                 5  
Unspecified                 8  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Axitinib + Cisplatin + Gemcitabine Axitinib (AG-013736) tablet 5 milligram (mg) starting dose orally twice daily continuously along with cisplatin 80 mg per square meter (mg/m^2) intravenous 2 hours infusion on day 1 of each cycle and gemcitabine 1250 mg/m^2 intravenous 30 minutes infusion on days 1 and 8 of each cycle up to 6 cycles (cycle length 21 days), in chemotherapy phase. Axitinib (AG-013736) tablet 5 mg orally twice daily continuously up to 15 cycles (cycle length 28 days), in single agent phase.

Baseline Measures
    Axitinib + Cisplatin + Gemcitabine  
Number of Participants  
[units: participants]
  38  
Age  
[units: Years]
Mean ± Standard Deviation
  60.5  ± 7.1  
Gender  
[units: Participants]
 
Female     4  
Male     34  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Objective Response (OR)   [ Time Frame: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78) ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline until death or assessed every 2 months (up to 28 days after the last dose) ]

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Baseline, assessed every 2 months (up to 28 days after the last dose) ]

4.  Secondary:   Duration of Response (DR)   [ Time Frame: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


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


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00735904     History of Changes
Other Study ID Numbers: A4061038
Study First Received: August 13, 2008
Results First Received: November 30, 2012
Last Updated: November 30, 2012
Health Authority: United States: Food and Drug Administration