Table 2. Objectives of Phase 1 oncology trials.

• Evaluate safety and tolerance

• Determine dose-limiting toxicity

• Define maximum tolerated dose

• Define optimal biologically active dose

• Determine dose and schedule for initial Phase 2 efficacy trials

• Evaluate pharmacokinetics (ADME*)

• Evaluate effects on molecular target or pathway

• Observe for preliminary evidence of antitumour activity

^*ADME, Absorption, distribution, metabolism, elimination.