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Spots Global Cancer Trial Database for Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer

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Trial Identification

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

Interventions

Proxalutamide

Study Description

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period is needed after 7-day single dose administration, until disease progression, intolerable toxicities (AEs), or withdrawn consent.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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Ke Chen

Affiliation: Suzhou Kintor Pharmaceuticals,inc

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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