Modern Dose-Finding Designs for Cancer Phase I Trials: Drug Combinations and Molecularly Targeted Agents

- Akihiro Hirakawa, Department of Biostatistics and Bioinformatics, Graduate School of Medicine, The University of Tokyo- Takashi Daimon, Division of Biostatistics, Hyogo College of Medicine- Hiroyuki Satom, Biostatistics Group, Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency- Shigeyuki Matsui, Department of Biostatistics, Nagoya University Graduate School of Medicine

• 1. Introduction.- 2. Phase I Trials for Drug Development in Oncology.- 3. A Summary of Dose.- Finding Methods in Standard Phase I Trials .- 4. Phase I Trials for Combination of Two Agents.- 5. Phase I Trials for Joint Assessment of Both Efficacy and Toxicity.- 6. Additional Topics on Adaptive Dose.- Finding Methods.