Study design and treatment
toxicity
This phase 1b, international, open-label, dose-escalation study used a modified toxicity probability interval (mTPI) design [Starting doses were based on pharmacokinetic (PK) data and the MTD of each agent when administered alone. Dose escalation and de-escalation decisions were based on the mTPI and were dependent upon the number of patients enrolled and number of DLTs at each dose level. 