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

March 3, 2025 updated by: Health Hope Pharma
This is a multicenter, open-label, single-arm PK study in patients for whom paclitaxel treatment is indicated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan, 110
        • Taipei Medical University Hospital
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital
      • Taipei, Taiwan, 23561
        • Shuang Ho Hospital
      • Taipei, Taiwan, 10048
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans Generla Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed written informed consent
  2. Women ≥18 years of age on day of consent
  3. Breast cancer in patients for whom treatment with IV paclitaxel at 80 mg/m2 as monotherapy has been recommended by their oncologist
  4. Measurable disease as per RECIST v1.1 criteria

  5. Adequate hematological status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) maintain:

    • Absolute neutrophil count (ANC) ≥1.5 x 10^9/L
    • Platelet count ≥100 x 10^9/L
    • Hemoglobin (Hgb) ≥9 g/dL

  6. Adequate liver function

    • Total bilirubin of ≤1.5 mg/dL
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) or ≤5 x ULN if liver metastasis is present
    • Alkaline phosphatase (ALP) ≤3 x ULN or ≤5 x ULN if bone metastasis is present
    • Gamma glutamyl transferase (GGT) <10 x ULN
  7. Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  9. Life expectancy of at least 3 months
  10. Willing to fast for 6 hours before and 2 hours after Oraxol administration on all treatment days
  11. Willing to abstain from alcohol consumption for 3 days before the first dose of study drug through the completion of the second inpatient PK sampling period
  12. Willing to refrain from caffeine consumption for 12 hours before each inpatient dosing period through the completion of protocol-specified PK sampling for that week
  13. Subjects must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of assigned study treatment.
  14. Subjects who are of childbearing potential must have a negative serum pregnancy test at Screening and within 96 hours before dosing.

Exclusion Criteria:

  1. Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
  2. If previously treated with a taxane (paclitaxel or docetaxel) as part of anthracycline-based adjuvant chemotherapy or for metastatic disease, the subject relapsed less than 1 year following treatment
  3. Subjects unable to swallow study medication in its intact form or have clinically significant malabsorption syndrome
  4. Only site of metastatic disease is unmeasurable according to RECIST v1.1 criteria
  5. Known CNS metastasis, including leptomeningeal involvement
  6. Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
  7. Are currently receiving other medications intended for the treatment of their malignancy
  8. Women who are pregnant or breastfeeding
  9. Taking prohibited medications:
  10. Use of warfarin. Subjects receiving warfarin who are otherwise eligible and who may be appropriately managed with low molecular weight heparin, in the opinion of the Investigator, may be enrolled in the study provided they are switched to low molecular weight heparin at least 7 days prior to receiving study treatment.
  11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease requiring oxygen, known bleeding disorders, or any concomitant illness or social situation that would limit compliance with study requirements
  12. Known allergic reaction or intolerance to study medication components
  13. Known allergic reaction or intolerance to contrast media
  14. Subjects who, in the Investigator's opinion, are not suitable for participation in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Oraxol
Subjects will receive Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
Drug: Oraxol
HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets, Paclitaxel - supplied as 30-mg capsules
Other Names:
  • HM30181 methanesulfonate monohydrate
  • Oral paclitaxel capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PK Parameters for paclitaxel_AUC (0-52)
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK parameters were summarized using the mean, SD
PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK Parameters for paclitaxel_Cmax
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK parameters were summarized using the mean, SD
PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK Parameters for paclitaxel_Ctrough(24)
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK parameters were summarized using the mean, SD
PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK Parameters for paclitaxel_Ctrough(48)
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK parameters were summarized using the mean, SD
PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK Parameters for paclitaxel_Cmax(0-24)
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK parameters were summarized using the mean, SD
PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK Parameters for paclitaxel_Cmax(24-48)
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK parameters were summarized using the mean, SD
PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK Parameters for paclitaxel_Cmax(48-52)
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK parameters were summarized using the mean, SD
PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK Parameters for paclitaxel_tmax(0-24)
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK parameters were summarized using the median, minimum, maximum
PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK Parameters for paclitaxel_tmax(24-48)
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK parameters were summarized using the median, minimum, maximum
PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK Parameters for paclitaxel_tmax(48-52)
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
PK parameters were summarized using the median, minimum, maximum
PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety of Oraxol in Breast Cancer Patients
Time Frame: From enrollment through study completion, approximately 17 weeks
Safety was assessed by evaluating treatment-emergent adverse events (TEAEs) including SAEs, laboratory evaluations (hematology, blood chemistry, and urinalysis), vital signs, physical examinations, and electrocardiograms (ECGs).
From enrollment through study completion, approximately 17 weeks
Response Rate
Time Frame: From baseline through study completion, around 21 weeks
Tumor response rate and 95% confidence interval (CI) were evaluated based on the number of subjects with any post-baseline CR or PR per RECIST 1.1 as assessed by the Investigator and the ICRRC.
From baseline through study completion, around 21 weeks
Progression-free Survival
Time Frame: From baseline through study completion, around 21 weeks

PFS was analyzed based on the Response Evaluable Population. The Kaplan-Meier (KM) method was used to estimate the medians of these variables with 95% CIs.

The Response Evaluable Population included all subjects who received at least 1 dose of study treatment and had at least 1 posttreatment tumor response evaluation
From baseline through study completion, around 21 weeks
Overall Survival
Time Frame: From baseline through study completion, around 21 weeks

OS was analyzed based on the Response Evaluable Population. The Kaplan-Meier (KM) method was used to estimate the medians of these variables with 95% CIs.

The Response Evaluable Population included all subjects who received at least 1 dose of study treatment and had at least 1 posttreatment tumor response evaluation
From baseline through study completion, around 21 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Health Hope Pharma

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PharmaEssentia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tsu-Yi Chao, MD, DMS, PhD, Taipei Medical University Shuang Ho Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KX-ORAX-007
  • U1111-1176-4228 (Other Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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