NCT03165955

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Health Hope Pharma · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Breastcancer

Interventions

Type	Name	Description
DRUG	Oraxol	HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets, Paclitaxel - supplied as 30-mg capsules

Timeline

• Start date: 2017-05-09
• Primary completion: 2018-11-22
• Completion: 2018-11-22
• First posted: 2017-05-24
• Last updated: 2025-03-12
• Results posted: 2020-07-08

Locations

6 sites across 1 country: Taiwan

Regulatory

• FDA-regulated drug study