PHASE I NONRANDOMIZED STUDY OF AN ANTIESTROGEN IN WOMEN

承包商应制定单剂量1期临床方案 对于各种试剂来评估药物吸收的参数， 血浆浓度-时间曲线、分布（在相关组织中， 在可行的情况下）、排泄和毒性。 任务II：多次给药安全性和药代动力学研究 承包商应制定多剂量安全性和药代动力学 化学预防剂的1期临床方案，以评估 安全性和毒性以及稳态药代动力学参数。 此外，药理学和/或癌症替代物的研究 可以进行终点生物标志物调节。 任务I和任务II的方案激活将在IRB和 FBA批准并从NCI收到所有化学预防药物 由承包商。承包商应将方案提交给NCI DCPC方案安全和审查委员会进行审查和评论， 解决NCI审查中提出的所有问题，并提交最终的 IRB批准的方案。承包商应准备所有材料 需要FDA批准。NCI将向FDA提交方案 并将保留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.