A PK Study of Oraxol in Breast Cancer Patients

Status Completed

Clinical Trial Summary

This is a multicenter, open-label, single-arm PK study in approximately 24 breast cancer patients for whom paclitaxel treatment is indicated.

Clinical Trial Description

This is a multicenter, open-label, single-arm PK study in approximately 24 breast cancer patients for whom paclitaxel treatment is indicated. The study contains 3 periods: the Screening / Baseline Period, the Treatment Period, and the Follow-up Period. A Final Visit will occur within 7 days of the last dose of study treatment. If subjects achieve stable disease (SD), partial response (PR), or complete response (CR) at the end of the Treatment Period, they may continue Oraxol treatment in a separate extension study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04993040
Study type	Interventional
Source	Athenex, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	April 22, 2019
Completion date	December 9, 2020

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