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
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Neoplasms, Carcinoma, Squamous Cell
Both
Head and Neck Neoplasms, Carcinoma, Squamous Cell
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 Site | Harvey, Illinois |
| 1200.43.00106 Boehringer Ingelheim Investigational Site | Peoria, Illinois |
| 1200.43.00107 Boehringer Ingelheim Investigational Site | Omaha, Nebraska |
| 1200.43.00105 Boehringer Ingelheim Investigational Site | Stony Brook, New York |
| 1200.43.00103 Boehringer Ingelheim Investigational Site | Philadelphia, Pennsylvania |
| 1200.43.00101 Boehringer Ingelheim Investigational Site | Little Rock, Arkansas |
| 1200.43.00114 Boehringer Ingelheim Investigational Site | Pembroke Pines, Florida |
| 1200.43.00110 Boehringer Ingelheim Investigational Site | Boston, Massachusetts |
| 1200.43.00102 Boehringer Ingelheim Investigational Site | Philadelphia, Pennsylvania |
| 1200.43.00112 Boehringer Ingelheim Investigational Site | Houston, Texas |
| 1200.43.00109 Boehringer Ingelheim Investigational Site | San Antonio, Texas |
