Overview

This trial is active, not recruiting.

Conditions head and neck neoplasms, carcinoma, squamous cell
Treatments afatinib, methotrexate
Phase phase 3
Targets EGFR, HER2, HER4
Sponsor Boehringer Ingelheim
Start date January 2012
End date March 2014
Trial size 483 participants
Trial identifier NCT01345682, 1200.43, 2011-000391-34

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Once daily
afatinib
Once daily
(Active Comparator)
Weekly
methotrexate
Weekly

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: From randomization until death or data cut-off (30Jun2014); Up to 29 months
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)
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)
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: 1. Histologically or cytologically confirmed R/M HNSCC of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy 2. Documented progressive disease based on investigator assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) following receipt of at least two cycles of cisplatin or carboplatin administered for R/M disease 3. Measurable disease according to RECIST 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion criteria: 1. Progressive disease within three months of completion of curatively intended treatment for locoregionally advanced or metastatic HNSCC 2. Any other than one previous platinum based systemic regimen given for R/M disease 3. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules 4. Pregnancy or breast feeding

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.