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

癌症预防和预防司化学预防处 国家癌症研究所的控制中心开发了一项计划，以 识别和开发可预防或抑制的人用药物 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， 化学预防部门正在寻求开发和验证中间体 癌症的终点生物标记物，即癌前生物和/或 靶上皮细胞中与癌症相关的分子变化 可以用化学预防药物调节的生物标记物。是这样的 中间终点生物标记物将显著缩短时间 有希望的化学预防措施的临床疗效评估所需 探员们。化学预防药物开发的进展正在认真进行 由于缺乏可以提供以下服务的替代终点生物标记物(SEB)而放缓 如前所述，更短、更便宜的癌症发病率替代品 减少临床试验。第二阶段化学预防试验评估 代用终点生物标志物调控的安全性和有效性 癌症。

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.