A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01152437
First received: June 28, 2010
Last updated: October 29, 2013
Last verified: October 2013
Results First Received: August 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Neoplasms
Interventions: Drug: BIBW 2992
Drug: Cetuximab

  Participant Flow
  Hide Participant Flow

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
Afatinib (Wild-type) Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
Cetuximab (Wild-type) Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
Afatinib (Mutated) Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.

Participant Flow:   Overall Study
    Afatinib (Wild-type)     Cetuximab (Wild-type)     Afatinib (Mutated)  
STARTED     36 [1]   15 [1]   43 [2]
COMPLETED     0     0     0  
NOT COMPLETED     36     15     43  
Other Adverse Event                 8                 1                 7  
Not treated                 0                 1                 2  
Progressive disease                 27                 13                 32  
Refusal to continue taking trial medicat                 1                 0                 2  
[1] randomised
[2] entered



  Baseline Characteristics
  Hide Baseline Characteristics

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.

Reporting Groups
  Description
Afatinib (Wild-type) Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
Cetuximab (Wild-type) Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
Afatinib (Mutated) Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
Total Total of all reporting groups

Baseline Measures
    Afatinib (Wild-type)     Cetuximab (Wild-type)     Afatinib (Mutated)     Total  
Number of Participants  
[units: participants]
  36     14     41     91  
Age  
[units: years]
Mean ± Standard Deviation
  62.5  ± 10.4     62.6  ± 7.7     60.0  ± 11.9     61.4  ± 10.8  
Gender  
[units: Number¬†of¬†participants]
       
Female     9     5     22     36  
Male     27     9     19     55  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Objective Response   [ Time Frame: Baseline till progression or death, whichever came first, assessed up to 23 months ]

2.  Primary:   Percentage of Participants With Disease Control (DC)   [ Time Frame: Baseline till progression or death, whichever came first, assessed up to 23 months ]

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Baseline till progression or death, whichever came first, assessed up to 23 months ]

4.  Secondary:   Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8)   [ Time Frame: day 8 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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: NCT01152437     History of Changes
Other Study ID Numbers: 1200.74, 2009-011996-59
Study First Received: June 28, 2010
Results First Received: August 8, 2013
Last Updated: October 29, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency