[Clinical development of new molecular targeted therapeutics for cancer therapy].
Recently much attention has been paid to clinical development of new drugs targeting the important molecules involved in cell growth, motility, invasion, metastatic formation of cancer cells and tumor angiogenesis. Among them, several drugs are designed to inhibit those activities, by which cancer growth and/or metastasis may be controlled. A major problem in developing new molecular targeted therapeutics is determining the optimal biological dose in Phase I studies. Appropriate surrogate markers should be employed to evaluate their therapeutic efficacy before entering the Phase III study. A future strategy to evaluate the efficacy of new drugs in combination with conventional anticancer therapy (surgery, radiotherapy and chemotherapy) is required. For this, careful consideration must be given to the design of clinical Phase III trials. This paper discusses the present status and future strategy for development of new molecular targeted therapeutics in clinics.
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Third Dept. of Internal Medicine, University of Tokushima School of Medicine.
D020533:Angiogenesis Inhibitors; D017209:Apoptosis; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004791:Enzyme Inhibitors / Q000627:therapeutic use; D006801:Humans; D006877:Hydroxamic Acids / Q000627:therapeutic use; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000093542:Gemcitabine
D020533:Angiogenesis Inhibitors; D004791:Enzyme Inhibitors; D006877:Hydroxamic Acids; D003841:Deoxycytidine; C100342:marimastat; D000093542:Gemcitabine