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

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究旨在观察KU-0059436药物是否有效且耐受性良好，用于治疗BCRA 1和BRCA 2相关的晚期卵巢癌。 样本量为40例患者。 主要目的是评估KU-0059436在患者口服给药时的客观肿瘤缓解率方面的疗效。 次要和探索性目的包括药效学、药物遗传学、生物标志物和生活质量。

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.