Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00818441
First received: January 5, 2009
Last updated: April 25, 2016
Last verified: April 2016
Results First Received: April 25, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Non-small Cell
Intervention: Drug: Dacomitinib (PF-00299804)

  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
Dacomitinib: Cohort A Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
Dacomitinib: Cohort B Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.

Participant Flow:   Overall Study
    Dacomitinib: Cohort A     Dacomitinib: Cohort B  
STARTED     89     30  
COMPLETED     0     0  
NOT COMPLETED     89     30  
Death                 69                 26  
Unspecified                 5                 0  
Lost to Follow-up                 2                 1  
Withdrawal by Subject                 2                 0  
Adverse Event                 0                 1  
Study terminated by sponsor                 11                 2  



  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.
No text entered.

Reporting Groups
  Description
Dacomitinib: Cohort A Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
Dacomitinib: Cohort B Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
Total Total of all reporting groups

Baseline Measures
    Dacomitinib: Cohort A     Dacomitinib: Cohort B     Total  
Number of Participants  
[units: participants]
  89     30     119  
Age  
[units: years]
Mean (Standard Deviation)
  62.7  (11.18)     57.3  (10.88)     61.3  (11.30)  
Gender  
[units: participants]
     
Female     60     15     75  
Male     29     15     44  



  Outcome Measures
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1.  Primary:   Progression-Free Survival (PFS) at Month 4: Cohort A   [ Time Frame: Baseline up to Month 4 ]

2.  Secondary:   Progression-Free Survival (PFS) at Month 4: Cohort B   [ Time Frame: Baseline up to Month 4 ]

3.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle. ]

4.  Secondary:   Best Overall Response (BOR)   [ Time Frame: Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle. ]

5.  Secondary:   Duration of Response (DR)   [ Time Frame: Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle. ]

6.  Secondary:   Overall Survival (OS)   [ Time Frame: Randomization until death or last date known to be alive. ]

7.  Secondary:   European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score   [ Time Frame: Baseline (Cycle [C]1 Day 1), up to C75 ]

8.  Secondary:   European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Score   [ Time Frame: Baseline (C1D1) up to C75 ]

9.  Secondary:   Trough Plasma Concentrations (Ctrough) of Dacomitinib   [ Time Frame: Predose on C1D14, C2D1, C3D1, C4D1 ]


  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
Results have been included for Cohort B and updated for Cohort A since the Primary completion date.


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00818441     History of Changes
Other Study ID Numbers: A7471017
2011-002794-39 ( EudraCT Number )
Study First Received: January 5, 2009
Results First Received: April 25, 2016
Last Updated: April 25, 2016
Health Authority: United States: Food and Drug Administration