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A Randomised, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Afatinib (BIBW 2992) as Adjuvant Therapy After Chemo-radiotherapy in Primary Unresected Patients With Stage III, IVa, or IVb Loco-regionally Advanced Head and Neck Squamous Cell Carcinoma


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

Thank you

Trial Information

A Randomised, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Afatinib (BIBW 2992) as Adjuvant Therapy After Chemo-radiotherapy in Primary Unresected Patients With Stage III, IVa, or IVb Loco-regionally Advanced Head and Neck Squamous Cell Carcinoma

Inclusion Criteria


Inclusion criteria:

1. Histologically or cytologically confirmed loco-regionally advanced head and neck
squamous cell carcinoma (HNSCC), stage III to IVb

2. Unresected tumour prior to chemo-radiotherapy (CRT)

3. Concomitant CRT completed prior to randomisation

4. After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and
radiographic examinations

5. Eastern cooperative oncology group (ECOG) performance status 0 or 1

Exclusion criteria:

1. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small
molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC

2. Patients with smoking history of less than or equal to 10 pack years and with primary
tumour site of base of tongue and/or tonsil

3. Any other malignancy (except for simultaneous HNSCC primaries, appropriately treated
superficial basal cell skin cancer and surgically cured cervical cancer in situ)
unless free of disease for at least five years

4. Known pre-existing Interstitial Lung Disease (ILD)

5. Pregnancy or breast feeding

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Disease Free Survival (DFS)

Outcome Time Frame:

Approximately 5 years

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:

1200.131

NCT ID:

NCT01345669

Start Date:

October 2011

Completion Date:

May 2019

Related Keywords:

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

Name

Location

1200.131.00178 Boehringer Ingelheim Investigational Site Los Angeles, California  
1200.131.00181 Boehringer Ingelheim Investigational Site Orange, California  
1200.131.00187 Boehringer Ingelheim Investigational Site New Orleans, Louisiana  
1200.131.00182 Boehringer Ingelheim Investigational Site Omaha, Nebraska  
1200.131.00175 Boehringer Ingelheim Investigational Site Lebanon, New Hampshire  
1200.131.00179 Boehringer Ingelheim Investigational Site Stony Brook, New York  
1200.131.00184 Boehringer Ingelheim Investigational Site San Antonio, Texas  
1200.131.00183 Boehringer Ingelheim Investigational Site Wenatchee, Washington  
1200.131.00171 Boehringer Ingelheim Investigational Site Little Rock, Alaska  
1200.131.00177 Boehringer Ingelheim Investigational Site Aurora, Colorado  
1200.131.00185 Boehringer Ingelheim Investigational Site New Haven, Connecticut  
1200.131.00191 Boehringer Ingelheim Investigational Site Harvey, Illinois  
1200.131.00173 Boehringer Ingelheim Investigational Site Baltimore, Maryland  
1200.131.00176 Boehringer Ingelheim Investigational Site Boston, Massachusetts  
1200.131.00190 Boehringer Ingelheim Investigational Site Boston, Massachusetts  
1200.131.00188 Boehringer Ingelheim Investigational Site Bronx, New York  
1200.131.00189 Boehringer Ingelheim Investigational Site Cleveland, Ohio  
1200.131.00172 Boehringer Ingelheim Investigational Site Philadelphia, Pennsylvania