PHASE I SAFETY & PHARMACOKINETIC CLINICAL TRIALS

承包商应开发多剂量安全性和药代动力学 异硫氰酸苯乙酯1期临床方案评价 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 终点生物标记物调节(例如，尿NNK代谢物和/或 加合物)是鼓励的。 协议激活将在IRB和FDA批准后进行，并且 承包商收到国家卫生研究院提供的所有化学预防药物(S)。 承包商应将协议提交给NCI DCPC协议安全和 审查委员会进行审查和评论，解决在 NCI审查，并提交最终方案供IRB批准。这个 承包商应准备FDA批准所需的所有材料。这个 NCI将向FDA提交该方案，并将举行IND。 议定书应至少包括以下内容的背景讨论 异硫氰酸苯乙酯(见S.S.Hecht、G.D.斯通纳和/或 F-LChung；另见癌症研究53：721-724,1993)。

The Contractor shall develop a multiple-dose safety and pharmacokinetic phase 1 clinical protocol for phenethyl isothiocyanate 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 (e.g. urinary NNK metabolites and/or adducts) are encouraged. Protocol activation will occur following IRB and FDA approval and the receipt of all chemopreventive drug(s) from the NCI by the Contractor. The Contractor shall submit the protocol to 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. The protocol shall include, as a minimum, a background discussion of phenethyl isothiocyanate (see the work of S.S. Hecht, G.D. Stoner, and/or F-L. Chung; see also Cancer Res. 53: 721-724, 1993).