PHASE I NONRANDOMIZED STUDY OF AN ANTIESTROGEN IN WOMEN

承包商应制定单剂1期临床方案 对于评估药物吸收参数的各种试剂， 血浆浓度-时间曲线、分布(在相关组织中， 在可行的情况下)、排泄物和毒性。 任务二：多剂量安全性和药代动力学研究 承包商应开发多剂量安全性和药代动力学 化学预防药物评估的第一阶段临床方案 安全性和毒性参数以及稳态药代动力学参数。 此外，药理和/或癌症替代物的研究 可以进行终点生物标记物调制。 任务I和任务II的协议激活将在IRB和 美国食品药品监督管理局的批准和从NCI获得的所有化学预防药物(S) 由承包商提供。承包商应将协议提交给NCI DCPC议定书安全和审查委员会审查和评论， 解决NCI审查中提出的所有问题，并提交最终的 IRB批准的协议。承包商应准备好所有材料 FDA批准所必需的。NCI将向FDA提交该方案 并将持有IND。

The Contractor shall develop a single-dose, phase 1 clinical protocol for a variety of agents to evaluate the parameters of drug absorption, plasma concentration-time profiles, distribution (in relevant tissues, where feasible), excretion and toxicity. Task II: Multiple-dose Safety and Pharmacokinetic Study The Contractor shall develop a multiple-dose safety and pharmacokinetic phase 1 clinical protocol for the chemopreventive agent to evaluate the parameters of safety and toxicity and of steady-state pharmacokinetics. In addition, investigations of pharmacological and/or cancer surrogate endpoint biomarker modulation may be undertaken. Protocol activation for Task I and Task II will occur following IRB and FBA approval and the receipt of all chemopreventive drug(s) from the NCI by the Contractor. The Contractor shall submit the protocol to the NCI DCPC Protocol Safety and Review Committee for review and comment, address all issues raised in the NCI review, and submit a finalized protocol for IRB approval. The Contractor shall prepare all materials necessary for FDA approval. The NCI will submit the protocol to the FDA and will hold the IND.