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A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01647711
First received: July 16, 2012
Last updated: December 8, 2016
Last verified: December 2016
History of Changes
Results First Received: September 22, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Intervention: Drug: Dose escalation followed by treatment with MTD

  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
Afatinib was administered until disease progression, however patients experiencing clinical benefit were allowed to continue treatment for as long as judged beneficial by the investigator.

Reporting Groups
  Description
Afatinib 90mg Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
Afatinib 120mg Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
Afatinib 150mg Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
Afatinib 160mg Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
Afatinib 200mg Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.

Participant Flow:   Overall Study
    Afatinib 90mg   Afatinib 120mg   Afatinib 150mg   Afatinib 160mg   Afatinib 200mg
STARTED   6   3   9   11   6 
COMPLETED   0   0   0   0   0 
NOT COMPLETED   6   3   9   11   6 
Progressive disease                6                2                6                8                2 
Other adverse event                0                0                2                0                2 
Protocol Violation                0                0                0                0                1 
Refused to continue taking medication                0                0                0                2                1 
Other reason not defined                0                1                1                1                0 



  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.
Treated set which included all patients who took at least one dose of afatinib.

Reporting Groups
  Description
Afatinib 90mg Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
Afatinib 120mg Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
Afatinib 150mg Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
Afatinib 160mg Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
Afatinib 200mg Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
Total Total of all reporting groups

Baseline Measures
   Afatinib 90mg   Afatinib 120mg   Afatinib 150mg   Afatinib 160mg   Afatinib 200mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 6   3   9   11   6   35 
Age 
[Units: Years]
Median (Full Range) 		 65.0 
 (64 to 80)  		 58.0 
 (50 to 77)  		 65.0 
 (54 to 77)  		 61.0 
 (45 to 70)  		 62.5 
 (54 to 75)  		 64.0 
 (45 to 80) 
Gender 
[Units: Participants]
Count of Participants 		           
Female      2  33.3%      1  33.3%      6  66.7%      10  90.9%      5  83.3%      24  68.6% 
Male      4  66.7%      2  66.7%      3  33.3%      1   9.1%      1  16.7%      11  31.4% 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Dose Limiting Toxicities   [ Time Frame: 28 days ]
  Show Outcome Measure 1

2.  Primary:   Maximum Tolerated Dose   [ Time Frame: 28 days ]
  Show Outcome Measure 2

3.  Secondary:   Objective Response Rate for Patients With EGFR T790M Mutations   [ Time Frame: From first drug administration until last drug administration, up to 420 days ]
  Show Outcome Measure 3

4.  Secondary:   Cmax of Afatinib on Day 3 of Course 1   [ Time Frame: 47 hours (h) 55 minutes (min), 49h, 50h, 51h, 52h, 53h, 54h, 55h after first dose administration (on day 3 of course 1) ]
  Show Outcome Measure 4

5.  Secondary:   Determination of Dosage for Expansion Cohort in Part B   [ Time Frame: 28 days ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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  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
One patient was screened in part B of the study, the patient did not meet eligibility requirements and was not treated. The trial completed enrollment in Part A before any additional patients were screened for Part B.


  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: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01647711     History of Changes
Other Study ID Numbers: 1200.121
Study First Received: July 16, 2012
Results First Received: September 22, 2016
Last Updated: December 8, 2016