PHASE 2 CLINICAL TRIAL OF AN ANTIANDROGEN & A 5-ALPHA

癌症预防与治疗部化学预防分支 国家癌症研究所的控制中心已经开发了一个项目， 鉴定和开发人类使用药物， 癌症的发展。 “癌症化学预防”是指 用药物预防侵袭性肿瘤。 作为该计划的一部分， 化学预防分支正在寻求开发和验证中间体 癌症的终点生物标志物，即，癌前生物学和/或 与癌症相关的靶上皮的分子变化 可以用化学预防剂调节的生物标志物。 等 中间终点生物标志物将显著缩短时间 需要对有前景的化学预防性药物进行临床疗效评价 剂. 化学预防药物开发的进展正受到严重关注。 由于缺乏替代终点生物标志物（SEB）， 作为癌症发病率的更早、更短和更便宜的替代品， 减少临床试验。 化学预防的2期试验评估 调节替代终点生物标志物的安全性和有效性 癌

The Chemoprevention Branch of the Division of Cancer Prevention and Control at the National Cancer Institute has developed a program to identify and develop for human use drugs which will prevent or suppress the development of cancer. "Cancer chemoprevention" refers to th prevention of invasive neoplasia with drugs. As part of this program, the Chemoprevention Branch is seeking to develop and validate intermediate endpoint biomarkers of cancer, i.e., precancerous biological and/or molecular changes in target epithelium that correlate with cancer biomarkers that can be modulated with a chemopreventive agent. Such intermediate endpoint biomarkers will significantly shorten the time required for clinical efficacy evaluation for promising chemopreventive agents. Progress in chemopreventive drug development is being seriously slowed by the lack of surrogate endpoint biomarkers (SEB) which can serve as earlier, shorter and less expensive substitutes for cancer incidence reduction on clinical trials. Phase 2 trials in chemoprevention evaluate safety and efficacy in the modulation of surrogate endpoint biomarkers of cancer.