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

TerminadoFase 3ClinicalTrials.gov

ID: NCT01345669Tipo: INTERVENTIONALInicio: 17 de oct de 2011Fin estimado: 12 de sept de 2016

Traducción no disponible, mostrando original

Resumen

This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb
Unresected tumour prior to chemo-radiotherapy (CRT)
Concomitant CRT completed prior to randomisation
After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and radiographic examinations
Eastern cooperative oncology group (ECOG) performance status 0 or 1

Criterios de exclusión

Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
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
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
Known pre-existing Interstitial Lung Disease (ILD)
Pregnancy or breast feeding

Intervenciones

drug

Placebo

Once daily

drug

Afatinib

Once daily

Ubicaciones

1200.131.05451 Boehringer Ingelheim Investigational Site

Ciudad Autonoma de Bs As, Argentina

1200.131.05457 Boehringer Ingelheim Investigational Site

Córdoba, Argentina

1200.131.05458 Boehringer Ingelheim Investigational Site

San Miguel de Tucumán, Argentina

1200.131.05452 Boehringer Ingelheim Investigational Site

Santa Fe, Argentina

1200.131.05453 Boehringer Ingelheim Investigational Site

Villa Domínico, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

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