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Re-Examination of the Design of Early Clinical Trials for Molecularly Targeted Drugs

Re-Examination of the Design of Early Clinical Trials for Molecularly Targeted Drugs. Richard Simon, D.Sc. National Cancer Institute linus.nci.nih.gov/brb. Objectives of Phase I Trials. Develop dose/schedule Determine whether the drug inhibits the targeted pathway. Dose/Schedule.

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Re-Examination of the Design of Early Clinical Trials for Molecularly Targeted Drugs