BIBW 2992 (Afatinib) in Combination With Pemetrexed in Advanced Solid Tumours

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01169675
First received: July 19, 2010
Last updated: January 29, 2014
Last verified: January 2014
Results First Received: October 30, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neoplasms
Interventions: Drug: BIBW 2992 low dose
Drug: BIBW 2992 high dose
Drug: pemetrexed
Drug: BIBW 2992 high dose 6 day
Drug: BIBW 2992 low dose 6 day
Drug: BIBW 2992 medium dose 6 day
Drug: BIBW 2992 medium dose

  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
Continuous Afatinib 30 mg Continuous Afatinib 30 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
Continuous Afatinib 40 mg Continuous Afatinib 40 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
Pulsed Afatinib 50 mg Pulsed Afatinib 50 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
Pulsed Afatinib 60 mg Pulsed Afatinib 60 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
Pulsed Afatinib 70 mg Pulsed Afatinib 70 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.

Participant Flow:   Overall Study
    Continuous Afatinib 30 mg     Continuous Afatinib 40 mg     Pulsed Afatinib 50 mg     Pulsed Afatinib 60 mg     Pulsed Afatinib 70 mg  
STARTED     20     3     7     17     6  
COMPLETED     0     0     0     0     0  
NOT COMPLETED     20     3     7     17     6  
Progressive disease                 13                 2                 5                 15                 1  
Dose Limiting Toxicity (DLT)                 1                 0                 0                 0                 2  
Adverse Event                 5                 1                 2                 0                 0  
Withdrawal by Subject                 1                 0                 0                 1                 2  
Other Reason Not Defined Above                 0                 0                 0                 1                 1  



  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 includes all randomized patients that received Afatinib or Pemetrexed

Reporting Groups
  Description
Continuous Afatinib 30 mg Continuous Afatinib 30 mg plus Pemetrexed
Continuous Afatinib 40 mg Continuous Afatinib 40 mg plus Pemetrexed
Pulsed Afatinib 50 mg Pulsed Afatinib 50 mg plus Pemetrexed
Pulsed Afatinib 60 mg Pulsed Afatinib 60 mg plus Pemetrexed
Pulsed Afatinib 70 mg Pulsed Afatinib 70 mg plus Pemetrexed
Total Total of all reporting groups

Baseline Measures
    Continuous Afatinib 30 mg     Continuous Afatinib 40 mg     Pulsed Afatinib 50 mg     Pulsed Afatinib 60 mg     Pulsed Afatinib 70 mg     Total  
Number of Participants  
[units: participants]
  20     3     7     17     6     53  
Age  
[units: years]
Mean ± Standard Deviation
  60.2  ± 9.4     53.7  ± 16.6     69.6  ± 10.5     57.9  ± 10.7     64.8  ± 7.4     60.8  ± 10.7  
Gender  
[units: participants]
           
Female     11     2     1     11     2     27  
Male     9     1     6     6     4     26  



  Outcome Measures
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1.  Primary:   Investigator Defined Dose Limiting Toxicity (DLT) During First Course of Treatment, Treated Set   [ Time Frame: DLT were assessed during the first cycle (days 1-21) ]

2.  Secondary:   Investigator Defined Dose Limiting Toxicity (DLT) During All Courses of Treatment, Treated Set   [ Time Frame: DLT were assessed during all cycles of treatment ]

3.  Secondary:   Objective Response (OR)   [ Time Frame: Every 6 weeks before week 48 and every 12 weeks after week 48 until progression ]

4.  Secondary:   Disease Control   [ Time Frame: Every 6 weeks before week 48 and every 12 weeks after week 48 until progression ]

5.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Every 6 weeks before week 48 and every 12 weeks after week 48 until progression ]

6.  Secondary:   Tumour Shrinkage   [ Time Frame: Every 6 weeks before week 48 and every 12 weeks after week 48 until progression ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01169675     History of Changes
Other Study ID Numbers: 1200.92
Study First Received: July 19, 2010
Results First Received: October 30, 2013
Last Updated: January 29, 2014
Health Authority: Canada: Health Canada