PHASE II/III CLINICAL TRIALS OF ANTICANCER AGENTS

本合同的目标是：1)当测试新的代理时 刚刚完成了I期试验，以确认剂量和 选定的时间表可在随后的第二阶段试验中安全给出；2)至 测定现有抗肿瘤药物的抗肿瘤活性，这些药物可以 当与克隆一起使用时，剂量显著增加 刺激因素或其他调节毒性或 抗肿瘤活性；3)测定其抗肿瘤活性 抗肿瘤药物和药物的组合；4)评估 可能与以下各项相关或预测的实验室参数 5)测定新药的抗肿瘤活性谱。 针对特定人类癌症的药物。 虽然合同将允许偶尔进行第三阶段试验，但主要的 重点应放在第二阶段的早期研究上，这些研究对 药物开发，需要快速启动、完成和数据 报道。

The objectives of this contract are: 1) when testing new agents which have just completed Phase I trials, to confirm that the dose and schedule chosen can be safely given in subsequent Phase II trials; 2) to determine the antitumor activity of existing antitumor agents which can administered in significantly higher doses when used with colony stimulating factors or other factors which modulate toxicity or antitumor activity; 3) to determine the antitumor activity of combinations of antitumor agents and modalities; 4) to evaluate the laboratory parameters which may correlate with or predict for response; and 5) to determine the spectrum of antitumor activity for new agents in selected human cancers. While the contract will permit occasional Phase III trials, the major emphasis shall be on the early Phase II studies which are pivotal for drug development and require rapid initiation, completion and data reporting.