Procedure
toxicity
REGRESSION
Dose escalation involved a run‐in period with DS‐1205c monotherapy for 7 days (Cycle 0), followed by combination treatment with DS‐1205c plus gefitinib (Cycle 1 and beyond). DS‐1205c was administered orally at doses of 200, 400, 800, 1000, and 1200 mg twice daily (BID), and in combination with open‐label oral gefitinib 250 mg once daily in 21‐day cycles.Safety review meetings (SRMs), consisting of the investigators and the sponsor's medical monitors, reviewed the safety data, including dose‐limiting toxicity (DLT) data, to recommend the dose for the next dose‐escalation cohort and the recommended dose for the dose‐expansion cohort. A Bayesian logistic regression model (BLRM) for inferring the probabilities of DLT at each dose level