Phase‖Tria Evaluate the potential efficacy of a new treatment Select a single type and stage of tumor Selection of patients measurable tumor good performance status, normal organ function Many common solid tumors have standard treatment, ethical approach used to test new novel therapy before standard therapy(dilemma
Phase II Trial • Evaluate the potential efficacy of a new treatment – Select a single type and stage of tumor – Selection of patients: measurable tumor, good performance status, normal organ function – Many common solid tumors have standard treatment, ethical approach used to test new novel therapy before standard therapy (dilemma)
Phase Trial Pivotal studies Help to establish a new treatment of standard Prospective, randomized studies comparing a new treatment against established therapy or placebo Balance prognostic pretreatment characteristics Statistical calculation of sample size Results provide powerful data to support clinical practice or even change guideline
Phase III Trial • Pivotal studies – Help to establish a new treatment of standard – Prospective, randomized studies comparing a new treatment against established therapy or placebo – Balance prognostic pretreatment characteristics – Statistical calculation of sample size – Results provide powerful data to support clinical practice or even change guideline
Outlines History of Drug Discovery New drug development and clinical trials Chemotherapy Development Targeted Agents and New Directions in Drug Development Clinical Uses of Systemic Therapy Systemic Therapy Process
Outlines • History of Drug Discovery • New drug development and clinical trials • Chemotherapy Development • Targeted Agents and New Directions in Drug Development • Clinical Uses of Systemic Therapy • Systemic Therapy Process
Single-agent and combination therapy Single-agent therapy Control symptoms in palliative therapy Combination therapy Improved response and toxicity Comparison of these two therapies
Single-agent and combination therapy • Single-agent therapy – Control symptoms in palliative therapy • Combination therapy – Improved response and toxicity • Comparison of these two therapies
Principles of Combination Chemotherapy Active as single agent Non-overlapping toxicity Synergistic efficacy Different patterns of resistance Optimal dose and schedule Drug dose individualized
Principles of Combination Chemotherapy • Active as single agent • Non-overlapping toxicity • Synergistic efficacy • Different patterns of resistance • Optimal dose and schedule • Drug dose individualized