Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer
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研究单位:[1]Suzhou Kintor Pharmaceutical Inc[2]Sun-Yat-sen University Cancer center Guangzhou, Fujian, China[3]The Fourth Hospital of Hebei Medical University Shijiazhuang, Hebei, China河北医科大学第四医院[4]Hunan Cancer Hospital Changsha, Hunan, China[5]Jiangsu Province Hospital Nanjing, Jiangsu, China[6]Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai, Shanghai, China[7]Tianjin Medical University Cancer Institute and Hospital Tianjin, Tianjin, China[8]Beijing Cancer Hospital Beijing, Beijing, China, 100142
This study is a multi-center, open-label, dose-esclation I/Ib clinical study to explore safety, efficacy an pharmacokinetics of proxalutamide in patients with metastatic breast cancer.
This study includes two stages, stage I: single- and multiple-dose tolerance and pharmacokinetic study; stage 2: preliminary efficacy and safety study.