A Randomized, Open-label Phase II Study of BIBW 2992 Versus Cetuximab (Erbitux) in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) After Failure of Platinum-containing Therapy With a Cross-over Period for Progressing Patients

简要总结

主要结局

次要结局

• Tumor Shrinkage After Crossover (Stage 2) as Per Investigator Assessments(From baseline assessed prior to first dose of Stage 2 study medication to 28 days after termination of Stage 2 treatment.)
• Best RECIST Assessment as Per Investigator Assessment for Stage 1 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment).(Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment)
• Best RECIST Assessment as Per ICR for Stage 1 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment).(Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment)
• Best RECIST Assessment as Per Investigator Assessment for Stage 2 (as as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment)(Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment)
• Best RECIST Assessment as Per ICR for Stage2 (as Confirmed Disease Control (Clinical Benefit) and Objective Response Are Simply Categories of RECIST Assessment)(Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment)
• Best RECIST Assessment as Onset of Confirmed Objective Response as Per Investigator Assessment for Stage 1(Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment)
• Best RECIST Assessment as Onset of Confirmed Objective Response as as Per ICR for Stage 1(Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment)
• Best RECIST Assessment as Onset of Confirmed Objective Response as Per Investigator Assessment for Stage 2(Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment)
• Best RECIST Assessment as Confirmed Duration of Objective Response and Disease Control as Per Investigator Assessment for Stage 1(Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment)
• Best RECIST Assessment as Confirmed Duration of Confirmed Objective Response and Disease Control as Per ICR for Stage 1(Response determined from randomization until patient started Stage 2 or within 28 days after termination of Stage 1 treatment)
• Best RECIST Assessment as Confirmed Duration of Objective Response and Disease Control as Per Investigator Assessment for Stage 2(Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment)
• Best RECIST Assessment as Confirmed Duration of Disease Control as Per ICR for Stage 2(Response determined during Stage 2 or within 28 days after termination of Stage 2 treatment)
• Progression Free Survival (PFS) Before Crossover Based on Investigator Assessment(From randomisation to disease progression in Stage 1 or death whichever occurred first before crossover.)
• Progression Free Survival (PFS) After Crossover Based on Investigator Assessment(From first administration of study medication after cross over to disease progression in Stage 2 or death whichever came first after crossover.)
• Overall Survival (OS)(From randomisation to data cut-off date.)
• Time to Deterioration in HRQoL - Stage 1(From randomisation to deterioration in HRQoL scores before crossover.)
• Patients With AEs Resulting in Diarrhea, Skin Rash, Dose Reduction, Treatment Discontinuation and Decreased Cardiac Left Ventricular Function(First administration of trial medication until 28 days after last drug administration)
• Incidence and Intensity of Adverse Events With Grading According CTCAE(First administration of trial medication until 28 days after last drug administration)
• Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 15 (Cpre,ss,15)(Day 15)
• Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 29 (Cpre,ss,29)(Day 29)
• Pre-dose Concentration of Afatinib in Plasma for Dose 40mg and 50mg at Steady State on Day 57 (Cpre,ss, 57)(Day 57)