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BreastcancerPhase 1NCT03165955

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

A Phase 1 study testing Oraxol in people with Breastcancer, run by Health Hope Pharma at 6 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breastcancer
What is being tested?
Oraxol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
6 sitesTaiwan
Study dates
9 May 2017to 22 Nov 2018
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent
  • Women ≥18 years of age on day of consent
  • Breast cancer in patients for whom treatment with IV paclitaxel at 80 mg/m2 as monotherapy has been recommended by their oncologist
  • Measurable disease as per RECIST v1.1 criteria
  • 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
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  • Platelet count ≥100 x 10^9/L
  • Hemoglobin (Hgb) ≥9 g/dL
  • 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
  • Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of at least 3 months
  • Willing to fast for 6 hours before and 2 hours after Oraxol administration on all treatment days
  • 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
  • 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
  • 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.
  • Subjects who are of childbearing potential must have a negative serum pregnancy test at Screening and within 96 hours before dosing.

Who cannot join

  • Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
  • 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
  • Subjects unable to swallow study medication in its intact form or have clinically significant malabsorption syndrome
  • Only site of metastatic disease is unmeasurable according to RECIST v1.1 criteria
  • Known CNS metastasis, including leptomeningeal involvement
  • Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
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  • Are currently receiving other medications intended for the treatment of their malignancy
  • Women who are pregnant or breastfeeding
  • Taking prohibited medications:
  • 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.
  • 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
  • Known allergic reaction or intolerance to study medication components
  • Known allergic reaction or intolerance to contrast media
  • Subjects who, in the Investigator's opinion, are not suitable for participation in this study

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Taiwan6 sites

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10048

  • Taipei Medical University Hospital

    Taipei, 110

  • Taipei Veterans Generla Hospital

    Taipei, 11217

  • Tri-Service General Hospital

    Taipei, 114

  • Shuang Ho Hospital

    Taipei, 23561

Other trials in Taiwan

About this study

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

Read the 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
Being tested
Oraxol
Keywords
breast cancer, paclitaxel
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OraxolDrug

    Also called HM30181 methanesulfonate monohydrate, Oral paclitaxel capsules

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

Study groups in NCT03165955
Study groupRoleWhat they receive
OraxolExperimentalSubjects will receive Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
Receives: Drug: Oraxol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PK Parameters for paclitaxel_AUC (0-52)

    PK parameters were summarized using the mean, SD

    Measured: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

  2. PK Parameters for paclitaxel_Cmax

    PK parameters were summarized using the mean, SD

    Measured: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

  3. PK Parameters for paclitaxel_Ctrough(24)

    PK parameters were summarized using the mean, SD

    Measured: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

  4. PK Parameters for paclitaxel_Ctrough(48)

    PK parameters were summarized using the mean, SD

    Measured: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

  5. PK Parameters for paclitaxel_Cmax(0-24)

    PK parameters were summarized using the mean, SD

    Measured: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

  6. PK Parameters for paclitaxel_Cmax(24-48)

    PK parameters were summarized using the mean, SD

    Measured: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

  7. PK Parameters for paclitaxel_Cmax(48-52)

    PK parameters were summarized using the mean, SD

    Measured: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

  8. PK Parameters for paclitaxel_tmax(0-24)

    PK parameters were summarized using the median, minimum, maximum

    Measured: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

  9. PK Parameters for paclitaxel_tmax(24-48)

    PK parameters were summarized using the median, minimum, maximum

    Measured: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

  10. PK Parameters for paclitaxel_tmax(48-52)

    PK parameters were summarized using the median, minimum, maximum

    Measured: 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 outcomes (4)

  1. Safety of Oraxol in Breast Cancer Patients

    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).

    Measured: From enrollment through study completion, approximately 17 weeks

  2. Response Rate

    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.

    Measured: From baseline through study completion, around 21 weeks

  3. Progression-free Survival

    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

    Measured: From baseline through study completion, around 21 weeks

  4. Overall Survival

    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

    Measured: From baseline through study completion, around 21 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2017
  2. Study start9 May 2017
  3. Primary completion22 Nov 2018
  4. Study completion22 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03165955
Sponsor's protocol ID
KX-ORAX-007
Other IDs
U1111-1176-4228
Status last verified
Mar 2025
First submitted
14 May 2017
Last updated
12 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dai MS, Chao TC, Chiu CF, Lu YS, Shiah HS, Jackson CGCA, Hung N, Zhi J, Cutler DL, Kwan R, Kramer D, Chan WK, Qin A, Tseng KC, Hung CT, Chao TY. Oral paclitaxel and encequidar in patients with breast cancer: a pharmacokinetic, safety, and antitumor activity study. Ther Adv Med Oncol. 2023 Jul 21;15:17588359231183680. doi: 10.1177/17588359231183680. eCollection 2023.

    PubMed 37492633

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oraxol in people with Breastcancer, run by Health Hope Pharma at 6 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03165955, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.

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