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A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients

Breastcancer Clinical Trial

Official title:
A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients

Clinical Trial Summary

This is a multicenter, open-label, single-arm PK study in 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 NCT03165955
Study type Interventional
Source Athenex, Inc.
Contact
Status Completed
Phase Phase 1
Start date May 9, 2017
Completion date November 22, 2018
View Details
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