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A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01858389
First received: May 6, 2013
Last updated: July 17, 2017
Last verified: July 2017
Results First Received: September 13, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Masking: No masking;   Primary Purpose: Treatment
Condition: Non-small Cell Lung Cancer
Intervention: Drug: Dacomitinib

  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
Of 41 participants enrolled in the study, 38 (16 with T790M mutation and 22 without T790M mutation) received study drug. Three of the enrolled participants without known T790M mutation did not receive treatment.

Reporting Groups
  Description
Dacomitinib, 45/60 mg, With T790M Mutation Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
Dacomitinib, 45/60 mg, Without T790M Mutation Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle.

Participant Flow:   Overall Study
    Dacomitinib, 45/60 mg, With T790M Mutation   Dacomitinib, 45/60 mg, Without T790M Mutation
STARTED   16 [1]   25 [1] 
Received Treatment   16   22 
COMPLETED   0   0 
NOT COMPLETED   16   25 
Death                1                3 
Study terminated by sponsor                0                2 
Withdrawal by Subject                0                1 
Progressive disease                10                11 
Not specified                2                4 
Adverse Event                3                1 
Did not receive treatment                0                3 
[1] Enrolled



  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.
All participants who received at least 1 dose of study medication.

Reporting Groups
  Description
Dacomitinib, 45/60 mg, With T790M Mutation Participants with documented T790M mutation in exon 20 of epidermal growth factor receptor received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle. Dose could be escalated beyond 60 mg after consultation with and approval of the sponsor.
Dacomitinib, 45/60 mg, Without T790M Mutation Participants with no known T790M mutation received dacomitinib, 45 mg, every 12 hours for 6 doses over Days 1-4 of a 1-week lead-in cycle. Following the lead-in cycle, all participants received dacomitinib, 60 mg, every 12 hours for 6 doses over Days 1-4 of each subsequent 2-week cycle.
Total Total of all reporting groups

Baseline Measures
   Dacomitinib, 45/60 mg, With T790M Mutation   Dacomitinib, 45/60 mg, Without T790M Mutation   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   22   38 
Age, Customized 
[Units: Participants]
     
Younger than 18 years   0   0   0 
Between 18 and 44 years   2   0   2 
Between 45 and 64 years   9   13   22 
65 years and older   5   9   14 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      12  75.0%      12  54.5%      24  63.2% 
Male      4  25.0%      10  45.5%      14  36.8% 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   6   9   15 
Black or African American   2   2   4 
Asian   7   10   17 
Other   1   1   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Best Overall Response (BOR) in Participants With T790M Mutation   [ Time Frame: From baseline until disease progression, up to 61 weeks. ]

2.  Primary:   Objective Response Rate (ORR) in Participants With T790M Mutation   [ Time Frame: From baseline to disease progression, up to 61 weeks. ]

3.  Secondary:   Disease Control Rate (DCR) for Participants With T790M Mutation   [ Time Frame: From baseline to baseline to disease progression, up to 61 weeks. ]

4.  Secondary:   Duration of Response in Participants With T790M Mutation   [ Time Frame: From baseline to date of disease progression or death, up to 61 weeks. ]

5.  Secondary:   Progression-free Survival   [ Time Frame: From baseline to disease progression or death, up to 61 weeks. ]

6.  Secondary:   Progression-free Survival at 4 Months   [ Time Frame: Month 4 ]

7.  Secondary:   Maximum Plasma Concentration (Cmax) for Dacomitinib and PF-05199265   [ Time Frame: Pre-dose (hour 0), 2, 4, 6, 8, and 10 hours post-dose on Day 4, Cycle 0. ]

8.  Secondary:   Time to Maximum Plasma Concentration (Tmax) for Dacomitinib and PF-05199265   [ Time Frame: Pre-dose (hour 0), 2, 4, 6, 8, and 10 hours post-dose on Day 4, Cycle 0. ]

9.  Secondary:   Changes From Time-matched Baseline in Adjusted Fridericia Corrected QT Interval (QTcF) on Echocardiogram (ECG)   [ Time Frame: From Baseline to Cycle 0, Day 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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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  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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01858389     History of Changes
Other Study ID Numbers: A7471047
Study First Received: May 6, 2013
Results First Received: September 13, 2016
Last Updated: July 17, 2017