PHASE II/III CLINICAL TRIALS OF ANTICANCER AGENTS

抗癌药物II/III期临床试验

• 批准号: 3607911
• 负责人: JOHN S KOVACH
• 金额: $ 13.96万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-05-01 至 1996-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3607911
• 关键词: Hodgkin's disease; acute leukemia; antileukemic agent; antineoplastics; breast neoplasms; carcinoma; chemical information system; chronic leukemia; clinical trials; colony stimulating factor; combination chemotherapy; dosage; drug adverse effect; drug delivery systems; drug quality /standard; head /neck neoplasm; human therapy evaluation; kidney neoplasms; liver neoplasms; lymphoma; melanoma; mesothelioma; neoplasm /cancer; neoplasm /cancer chemotherapy; ovary neoplasms; pancreas neoplasms; salivary gland neoplasms; small cell lung cancer; testis neoplasms; thyroid neoplasm

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 be administered in significantly higher doses when used with colony stimulating factors or other factors which modulate toxicity and 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.

该合同的目标是：1）测试新代理时 刚刚完成了I期试验，以确认剂量和 可以在随后的II期试验中安全地给出选择的时间表； 2）到 确定现有抗肿瘤剂的抗肿瘤活性 与菌落一起使用时，以明显更高的剂量给药 刺激因素或其他调节毒性和的因素 抗肿瘤活性； 3）确定抗肿瘤活性 抗肿瘤剂和方式的组合； 4）评估 实验室参数可能与或预测 回复; 5）确定新的抗肿瘤活性的光谱 选定的人类癌症中的特工。 虽然合同将允许偶尔进行III期试验，但专业 重点应放在第二阶段的早期研究上，这是至关重要的 药物开发并需要快速启动，完成和数据 报告。