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Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer

2019-10-01 07:55:13 | BioPortfolio

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.

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period is needed after 7-day single dose administration, until disease progression, intolerable toxicities (AEs), or withdrawn consent.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

Study Design

Conditions

Metastatic Breast Cancer

Intervention

Proxalutamide

Location

Beijing Cancer Hospital
Beijing
Beijing
China
100142

Status

Active, not recruiting

Source

Suzhou Kintor Pharmaceutical Inc,

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-01T07:55:13-0400

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