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Brief Title: Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer
Official Title: Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer: an Open-label, Multi-center, Dose-escalating,Phase I/Ib Study.
Study ID: NCT04103853
Brief Summary: 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.
Detailed Description: This study is a multi-center, open-label, dose-esclation study. Subjects will be enrolled to the 100mg, 200mg, 300mg, 400mg and 500mg group in turn. Unless DLT was found, the dose esclation will continue. 28 days of DLT observation period is needed after 7-day single dose administration, until disease progression, intolerable toxicities (AEs), or withdrawn consent. After the completion of stage 1, 2 doses for the stage 2 will be determined. In stage 2, patients with AR-positive metastatic breast cancer will be selected to explore the efficacy and safety of proxalutamide, and biomarkers will be explored.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Beijing Cancer Hospital, Beijing, Beijing, China
Sun-Yat-sen University Cancer center, Guangzhou, Fujian, China
The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
Name: Ke Chen
Affiliation: Suzhou Kintor Pharmaceuticals,inc
Role: STUDY_DIRECTOR