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BreastcancerPhase 1NCT04993040

A PK Study of Oraxol in Breast Cancer Patients

A Phase 1 study testing Oraxol in people with Breastcancer, run by Athenex, Inc. at 1 site in China.

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 approximately 24 breast cancer 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
24 participants
Where
1 siteChina
Study dates
22 Apr 2019to 9 Dec 2020
Phase
Phase 1
Are there results?
None posted in the registry

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) to maintain:
  • Absolute neutrophil count (ANC) ≥1.5 x 109/L
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  • Platelet count ≥100 x 109/L
  • Hemoglobin (Hgb) ≥9 g/dL
  • Adequate liver function as demonstrated by:
  • 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 (Weeks 1 and 4) 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 Week 1 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 any of the following prohibited medications:
  • Strong inhibitors (eg, ketoconazole) or inducers (eg, rifampin or St. John's Wort) of CYP3A4 (within 2 weeks prior to the start of dosing in the study)
  • Strong inhibitors (eg, gemfibrozil) or inducers (eg, rifampin) of CYP2C8 (within 2 weeks prior to the start of dosing in the study)
  • Strong P-gp inhibitors or inducers. Subjects who are taking such medications but who are otherwise eligible may be enrolled if they discontinue the medication ≥1 week before dosing and remain off that medication through the end of study treatment.
  • An oral medication with a narrow therapeutic index known to be a P-gp substrate (eg,digoxin, dabigatran) within 24 hours prior to start of dosing in the study
  • 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

1 site in 1 country.

China1 site

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

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

This is a multicenter, open-label, single-arm PK study in approximately 24 breast cancer 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 - supplied as 15-mg HM30181AK-US tablets, Paclitaxel - supplied as 30-mg capsules

    • HM30181 methanesulfonate monohydrate
    • Oral paclitaxel capsules
Study groups in NCT04993040
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. Cmax

    Plasma concentrations for paclitaxel only will be analyzed to determine the maximum observed concentration (Cmax).

    Pharmacokinetic parameters will be summarized using the mean, standard deviation, median, minimum, and maximum. Summaries of PK parameters will also include the geometric mean and the coefficient of variation. Summary PK and individual timepoints will be tabulated and displayed graphically and listed for all subjects.

    Measured: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose

  2. Cmin

    Plasma concentrations for paclitaxel only will be analyzed to determine the minimum observed concentration (Cmin).

    Pharmacokinetic parameters will be summarized using the mean, standard deviation, median, minimum, and maximum. Summaries of PK parameters will also include the geometric mean and the coefficient of variation. Summary PK and individual timepoints will be tabulated and displayed graphically and listed for all subjects.

    Measured: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose

  3. Cavg

    Plasma concentrations for paclitaxel only will be analyzed to determine the area under the curve extrapolated to infinity (AUC0-t).

    Pharmacokinetic parameters will be summarized using the mean, standard deviation, median, minimum, and maximum. Summaries of PK parameters will also include the geometric mean and the coefficient of variation. Summary PK and individual timepoints will be tabulated and displayed graphically and listed for all subjects.

    Measured: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose

  4. AUC0-t

    Plasma concentrations for paclitaxel only will be analyzed to determine the area under the curve (AUC).

    Pharmacokinetic parameters will be summarized using the mean, standard deviation, median, minimum, and maximum. Summaries of PK parameters will also include the geometric mean and the coefficient of variation. Summary PK and individual timepoints will be tabulated and displayed graphically and listed for all subjects.

    Measured: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose

  5. AUC

    Plasma concentrations for paclitaxel only will be analyzed to determine the area under the curve (AUC).

    Pharmacokinetic parameters will be summarized using the mean, standard deviation, median, minimum, and maximum. Summaries of PK parameters will also include the geometric mean and the coefficient of variation. Summary PK and individual timepoints will be tabulated and displayed graphically and listed for all subjects.

    Measured: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose

Secondary outcomes (4)

  1. Safety

    all AEs (including for both increasing and decreasing severity) and SAEs by CTCAE v4.03

    Measured: From screening until final visit (within within 7 days after last dose of study treatment)

  2. Tumor response rate

    which is defined as the number of subjects with complete response (CR) or partial response (PR) at any post-baseline assessments by RECIST 1.1

    Measured: From screening until final visit (within within 7 days after last dose of study treatment)

  3. Progression-free survival

    Progression Free Survival (PFS) based on investigator's assessment according to RECIST 1.1

    Measured: From date of dosing until the date of first documented progression or date of death from any cause, whichever came first, estimated up to 24 months

  4. Overall survival

    OS is defined as the length of time from 1st dosing until the date of death from any cause

    Measured: From date of dosing until the date of death from any cause, whichever came first, estimated up to 24 months

Timeline

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

  1. First posted6 Aug 2021
  2. Study start22 Apr 2019
  3. Primary completion9 Dec 2019
  4. Study completion9 Dec 2020

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04993040
Sponsor's protocol ID
KX-ORAX-CN-007
Status last verified
Feb 2021
First submitted
11 Mar 2019
Last updated
6 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oraxol in people with Breastcancer, run by Athenex, Inc. at 1 site in China.

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 18 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 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Cmax (time frame: Week 1 (Days 1,2, 3): Predose, and at 1, 2, 3, and 4 hours postdose; Week 4 (Days 1,2,3): Predose, and at 1, 2, 3, and 4 hours postdose). The study lists 5 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 NCT04993040.

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 6 Aug 2021.

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