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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Neoplasms, Carcinoma, Squamous Cell

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Trial Information

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

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary efficacy endpoint of the trial is progression free survival (PFS)

Outcome Time Frame:

Approximately 9 months

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica

Study ID:

1200.43

NCT ID:

NCT01345682

Start Date:

January 2012

Completion Date:

July 2014

Related Keywords:

  • Head and Neck Neoplasms
  • Carcinoma, Squamous Cell
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

1200.43.00113 Boehringer Ingelheim Investigational SiteHarvey, Illinois  
1200.43.00106 Boehringer Ingelheim Investigational SitePeoria, Illinois  
1200.43.00107 Boehringer Ingelheim Investigational SiteOmaha, Nebraska  
1200.43.00105 Boehringer Ingelheim Investigational SiteStony Brook, New York  
1200.43.00103 Boehringer Ingelheim Investigational SitePhiladelphia, Pennsylvania  
1200.43.00101 Boehringer Ingelheim Investigational SiteLittle Rock, Arkansas  
1200.43.00114 Boehringer Ingelheim Investigational SitePembroke Pines, Florida  
1200.43.00110 Boehringer Ingelheim Investigational SiteBoston, Massachusetts  
1200.43.00102 Boehringer Ingelheim Investigational SitePhiladelphia, Pennsylvania  
1200.43.00112 Boehringer Ingelheim Investigational SiteHouston, Texas  
1200.43.00109 Boehringer Ingelheim Investigational SiteSan Antonio, Texas