A Randomised, Open-label, Phase III Study to Evaluate the Efficacy and Safety of Oral Afatinib (BIBW 2992) Versus Intravenous Methotrexate in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma Who Have Progressed After Platinum-based Therapy
Overview
- Phase
- Phase 3
- Intervention
- Methotrexate
- Conditions
- Head and Neck Neoplasms
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 483
- Locations
- 101
- Primary Endpoint
- Progression-free Survival (PFS) Based on Central Independent Review
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Methotrexate
Weekly
Intervention: Methotrexate
Afatinib (BIBW 2992)
Once daily
Intervention: Afatinib
Outcomes
Primary Outcomes
Progression-free Survival (PFS) Based on Central Independent Review
Time Frame: From randomization until disease progression, death or study completion date (06Dec2016); Up to 60 months
PFS was defined as the time from the date of randomisation to disease progression or death, whichever occurred first. The primary analysis of PFS considered PFS events as assessed by central independent review, including all data collected until the study completion date (06 December 2016). The date of disease progression was recorded based on RECIST version 1.1. Unequivocal progression of disease was determined if at least one of the following criteria applied: * At least 20% increase in the Sum of Diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm * Appearance of one or more new lesions * Unequivocal progression of existing non-target lesions
Secondary Outcomes
- Tumour Shrinkage(Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months)
- Overall Survival (OS)(From randomization until death or study completion date (06Dec2016); Up to 60 months)
- Time to Deterioration in Global Health Status(From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.)
- Objective Response (OR)(Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months)
- Disease Control (DC)(Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months)
- Health Related Quality of Life (HRQOL)- Change in Pain Scores Over Time(From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.)
- Health Related Quality of Life (HRQOL)- Change in Swallowing Scores Over Time(From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.)
- Health Related Quality of Life (HRQOL)- Change in Global Health Scores Over Time(From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.)
- Status Change in Pain Scale(From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.)
- Status Change in Swallowing Scale(From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.)
- Status Change in Global Health Status Scale(From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.)
- Time to Deterioration in Pain(From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.)
- Time to Deterioration in Swallowing(From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.)