At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
Oraxoldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients
In Brief
A Phase 1 clinical trial evaluating Oraxol for Breastcancer. Completed, enrolled 28 participants across 6 sites.
Detailed Summary
This is a multicenter, open-label, single-arm PK study in patients for whom paclitaxel treatment is indicated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreastcancer
CountriesTaiwan
CollaboratorsPharmaEssentia
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
Enrollment StartMay 2017
First PostedMay 2017
Primary CompletionNov 2018
TodayJul 2026
First PostedMay 24, 2017
Enrollment StartMay 9, 2017
Primary CompletionNov 22, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.1 years ago
Interventions
Oraxoldrug
HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets, Paclitaxel - supplied as 30-mg capsules