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

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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.