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LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01345682
First received: April 28, 2011
Last updated: October 17, 2016
Last verified: October 2016
Results First Received: March 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Head and Neck Neoplasms
Carcinoma, Squamous Cell
Interventions: Drug: Afatinib
Drug: Methotrexate

  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
Afatinib (BIBW 2992) Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
Methotrexate Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.

Participant Flow:   Overall Study
    Afatinib (BIBW 2992)   Methotrexate
STARTED   322 [1]   161 [1] 
COMPLETED   16 [2]   4 [2] 
NOT COMPLETED   306   157 
Progressive disease per RECIST                215                89 
Worsening of underlying cancer disease                21                13 
Adverse Event                49                41 
Non-compliance with protocol                0                1 
Lost to Follow-up                0                1 
Refused to continue trial medication                16                9 
Not treated                2                1 
Reason other than those specified above                3                2 
[1] Randomised
[2] On treatment at analysis cut-off date (07May2014)



  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.
The randomised set (RS) included all patients who were randomised to receive treatment, whether treated or not

Reporting Groups
  Description
Afatinib (BIBW 2992) Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
Methotrexate Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
Total Total of all reporting groups

Baseline Measures
   Afatinib (BIBW 2992)   Methotrexate   Total 
Overall Participants Analyzed 
[Units: Participants]
 322   161   483 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.0  (8.8)   59.3  (9.7)   59.8  (9.1) 
Gender 
[Units: Participants]
     
Female   47   24   71 
Male   275   137   412 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival (PFS) Based on Central Independent Review   [ Time Frame: From randomization until disease progression, death or data cut-off (07May2014); Up to 28 months ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: From randomization until death or data cut-off (30Jun2014); Up to 29 months ]

3.  Secondary:   Objective Response (OR)   [ Time Frame: Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (Up to 28 months) ]

4.  Secondary:   Disease Control (DC)   [ Time Frame: Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (Up to 28 months) ]

5.  Secondary:   Tumour Shrinkage   [ Time Frame: Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (Up to 28 months) ]

6.  Secondary:   Health Related Quality of Life (HRQOL)- Change in Pain Scores Over Time   [ Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months. ]

7.  Secondary:   Health Related Quality of Life (HRQOL)- Change in Swallowing Scores Over Time   [ Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months. ]

8.  Secondary:   Health Related Quality of Life (HRQOL)- Change in Global Health Scores Over Time   [ Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months. ]

9.  Secondary:   Status Change in Pain Scale   [ Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months. ]

10.  Secondary:   Status Change in Swallowing Scale   [ Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months. ]

11.  Secondary:   Status Change in Global Health Status Scale   [ Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months. ]

12.  Secondary:   Time to Deterioration in Pain   [ Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months. ]

13.  Secondary:   Time to Deterioration in Swallowing   [ Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months. ]

14.  Secondary:   Time to Deterioration in Global Health Status   [ Time Frame: From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months. ]


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


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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01345682     History of Changes
Other Study ID Numbers: 1200.43
2011-000391-34 ( EudraCT Number: EudraCT )
Study First Received: April 28, 2011
Results First Received: March 13, 2015
Last Updated: October 17, 2016
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Brazil: National Health Surveillance Agency
Czech Republic: State Institute for Drug Control
Denmark: The Danish Health and Medicines Authority
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Israel: Ministry of Health
Italy: Ethics Committee
Japan: Pharmaceuticals and Medical Devices Agency
Mexico: Federal Commission for Protection Against Health Risks
Russia: Pharmacological Committee, Ministry of Health
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
United States: Food and Drug Administration