68  Dose-Limiting Toxicity & Escalation

68.1 What is a DLT?

A toxicity that limits further dose escalation.

68.2 CRA Implications

• Critical documentation of timing and severity
• Close monitoring of Cycle 1
• Safety review committees (SRC/DSMB)

68.3 Escalation Designs

• 3+3
• Bayesian adaptive models
• Modified toxicity probability interval (mTPI)