A Phase Ib Open Label Clinical Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 Plus Sirolimus in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib or Gefitinib

简要总结

主要结局

次要结局

• Best Overall Response(From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days)
• Objective Response(From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days)
• Rate of Disease Control(From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days)
• Exploratory Examination of EGFR Mutations (Exons 19, 20 and 21 and Others) in Serum/Plasma DNA and Tumour DNA.(Multiple time points during the trial)
• Maximum Measured Plasma Concentration of Afatinib at Steady State (Cmax,ss)(24 hours (h), 311h 55minutes (min), 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h and 336h after first administration of afatinib)
• AUC of Afatinib at Steady State Over the Dosing Interval τ (AUCτ,ss)(24 hours (h), 311h 55minutes (min), 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h and 336h after first administration of afatinib)
• Maximum Measured Plasma Concentration of Sirolimus at Steady State (Cmax,ss)(24 hours (h) 5 minutes (min), 24h, 23h, 22h, 20h, 18h, 16h, 5min before first afatinib administration and 144h, 311h 55min, 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h, 336h, 480h after first administration of afatinib)
• AUC of Sirolimus at Steady State Over the Dosing Interval τ (AUCτ,ss)(24 hours (h) 5 minutes (min), 24h, 23h, 22h, 20h, 18h, 16h, 5min before first afatinib administration and 144h, 311h 55min, 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h, 336h, 480h after first administration of afatinib)
• Occurrence of Adverse Events According to CTCAE, Version 3.0(From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days)
• Percentage of Patients With Drug-related AEs(From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days)
• Frequency of Patients With Possible Clinically-significant Abnormalities in Liver Enzymes or Total Bilirubin(From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days)