PHASE II/III CLINICAL TRIALS OF ANTICANCER AGENTS

抗癌药物II/III期临床试验

• 批准号: 3607928
• 负责人: MARTIN NEWMAN RABER
• 金额: $ 31.22万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 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/3607928
• 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 subject; 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 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.

该合同的目标是： 1) 在测试新代理时， 刚刚完成第一阶段试验，以确认剂量和 所选择的时间表可以在随后的第二阶段试验中安全地给出； 2）到 确定现有抗肿瘤药物的抗肿瘤活性 当与菌落一起使用时，以显着更高的剂量施用 刺激因素或其他调节毒性的因素或 抗肿瘤活性； 3) 测定抗肿瘤活性 抗肿瘤药物和治疗方式的组合； 4）评估 可能与相关或预测的实验室参数 回复; 5) 确定新药物的抗肿瘤活性谱 某些人类癌症的药物。 虽然合同将允许偶尔进行第三阶段试验，但主要 重点应放在早期的二期研究上，这对于 药物开发需要快速启动、完成和数据 报告。