Kelloff G J, Crowell J A, Hawk E T, Steele V E, Lubet R A, Boone C W, Covey J M, Doody L A, Omenn G S, Greenwald P, Hong W K, Parkinson D R, Bagheri D, Baxter G T, Blunden M, Doeltz M K, Eisenhauer K M, Johnson K, Knapp G G, Longfellow D G, Malone W F, Nayfield S G, Seifried H E, Swall L M, Sigman C C
Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI), Bethesda, MD 20892, USA.
J Cell Biochem Suppl. 1996;26:54-71. doi: 10.1002/jcb.240630705.
This is the second publication of Clinical Development Plans from the National Cancer Institute, Division of Cancer Prevention and Control, Chemoprevention Branch and Agent Development Committee. The Clinical Development Plans summarize the status of promising chemopreventive agents regarding evidence for safety and chemopreventive efficacy in preclinical and clinical studies. They also contain the strategy for further development of these drugs, addressing pharmacodynamics, drug effect measurements, intermediate biomarkers for monitoring efficacy, toxicity, supply and formulation, regulatory approval, and proposed clinical trials. Sixteen new Clinical Development Plans are presented here: curcumin, dehydroepiandrosterone, folic acid, genistein, indole-3-carbinol, perillyl alcohol, phenethyl isothiocyanate, 9-cis-retinoic acid, 13-cis-retinoic acid, l-selenomethionine and 1, 4-phenylenebis(methylene)selenocyanate, sulindac sulfone, tea, ursodiol, vitamin A, and (+)-vorozole. The objective of publishing these plans is to stimulate interest and thinking among the scientific community on the prospects for developing these and future generations of chemopreventive drugs.
这是美国国立癌症研究所癌症预防与控制司化学预防分支及药物研发委员会发布的第二份临床开发计划。这些临床开发计划总结了在临床前和临床研究中，有前景的化学预防药物在安全性和化学预防功效方面的证据情况。计划还包含了这些药物进一步开发的策略，涉及药效学、药物效果测量、监测疗效的中间生物标志物、毒性、供应与制剂、监管审批以及拟进行的临床试验。本文展示了16项新的临床开发计划：姜黄素、脱氢表雄酮、叶酸、染料木黄酮、吲哚 - 3 - 甲醇、紫苏醇、苯乙基异硫氰酸酯、9 - 顺式维甲酸、13 - 顺式维甲酸、L - 硒代蛋氨酸和1,4 - 亚苯基双（亚甲基）硒氰酸酯、舒林酸砜、茶、熊去氧胆酸、维生素A以及（+） - 伏洛唑。发布这些计划的目的是激发科学界对开发这些及未来几代化学预防药物前景的兴趣和思考。
