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

NCT03165955 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-03-12

Study results available
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Summary

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

Conditions

  • Breastcancer

Interventions

DRUG

Oraxol

HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets, Paclitaxel - supplied as 30-mg capsules

Sponsors & Collaborators

  • PharmaEssentia

    collaborator INDUSTRY

  • Health Hope Pharma

    lead INDUSTRY

Principal Investigators

  • Tsu-Yi Chao, MD, DMS, PhD · Taipei Medical University Shuang Ho Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-09
Primary Completion
2018-11-22
Completion
2018-11-22
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03165955 on ClinicalTrials.gov