CLINICAL TRIAL: A PHASE II, OPEN-LABEL, NON-COMPARATIVE, INTERNATIONAL, MULTICEN

临床试验：二期、开放标签、非比较、国际、多中心

• 批准号: 7716668
• 负责人: JEFFREY N WEITZEL
• 金额: $ 0.48万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-20 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716668
• 关键词: Biological Markers; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Funding; Grant; Individual; Institution; International; Label; Malignant neoplasm of ovary; Patients; Pharmacodynamics; Pharmacogenetics; Phase; Quality of life; Rate; Research; Research Personnel; Resources; Sample Size; Source; United States National Institutes of Health; comparative; design; response; tumor

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study is designed to see if agent KU-0059436 is effective and well-tolerated in treating individuals with BCRA1- and BRCA2-associated advanced ovarian cancer. Sample size is 40 patients. The primary objective is to assess the efficacy of KU-0059436 in terms of objective tumor response rate when administered orally to patients. Secondary and exploratory objects include pharmacodynamics, pharmacogenetics, biomarkers and quality of life.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究旨在了解KU-0059436在治疗BCRA1和BRCA2相关的晚期卵巢癌患者中是否有效和耐受性良好。样本量为40例患者。主要目的是评估KU-0059436口服给药时客观的肿瘤反应率的疗效。次要和探索性对象包括药效学、药物遗传学、生物标志物和生活质量。