Strategies for Incorporating Pharmacokinetic Studies into Oncology Phase I Trials

The ultimate goal of therapeutics is to ensure that the appropriate treatment is administered to the individual patient at the most appropriate dose for optimal effects. In drug development, clinical trials are conducted in 3 broad phases (Phase I, II and III) before registration for a new drug is granted. In Phase I clinical trials, the primary objectives are to define safety and tolerability of a new treatment and to establish the recommended dose/s for efficacy studies. Clinical pharmacokinetics (PK) is an invaluable tool that can help with achieving this goal, when applied early and throughout the clinical drug development phases. In this chapter, the following topics will be covered: 1. Selected PK concepts specific to clinical drug development of oncology drugs. 2. Practical issues in designing PK studies in Phase I trials. 3. Application of PK in specific situations and drug interactions.