Solid TumorPhase 1NCT04035473
A Study to Determine the Bioequivalence of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel
A Phase 1 study testing HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules in people with Solid Tumor, run by Athenex, Inc. at 7 sites in 3 countries.
Trial summary
This is a multicenter, open-label, 2-stage study with a 2-treatment period crossover design. Eligible participants are adults with cancer for whom weekly therapy with IV paclitaxel at a dose of 80 mg/m2 over 1 hour is indicated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 1 Aug 2015to 27 Mar 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Males and females ≥18 years of age on day of consent
- Cancer patients for whom treatment with IV paclitaxel at 80 mg/m2has been recommended by their oncologist, either as monotherapy or in combination with other agents
- Adequate hematologic status at Screening/Baseline:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L
- Platelet count ≥100 x 109/L
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- Hemoglobin (Hgb) ≥90 g/L
- Adequate liver function at Screening/Baseline as demonstrated by:
- Total bilirubin of ≤20 μmol/L or ≤30 μmol/L for participants with liver metastasis
- Alanine aminotransferase (ALT) ≤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 liver or bone metastasis are present
- ALP >5 x ULN if liver or bone metastasis are present and the major fraction of ALP is from bone metastasis, at the discretion of the Investigator
- Gamma glutamyl transferase (GGT) <10 x ULN
- Adequate renal function at Screening/Baseline as demonstrated by serum creatinine ≤177 μmol/L or creatinine clearance >50 mL/min as calculated by the Cockcroft and Gault formula
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 16
- Life expectancy of at least 3 months
- Willing to fast for 8 hours before and 4 hours after Oraxol administration
- Willing to abstain from alcohol consumption for 3 days before the first dose of study drug through the completion of protocol-specified PK sampling in Treatment Period 2
- Willing to refrain from caffeine consumption for 12 hours before each treatment period through the completion of protocol-specified PK sampling for that dose
- Women must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or, if sexually active, 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 the duration of their participation in the study. Women of childbearing potential must agree to use contraception for 30 days after their last dose of study drug.
- Sexually active male participants must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug.
Who cannot join
- Currently taking a prohibited concomitant medication:
- Strong inhibitors (eg, ketoconazole) or strong inducers (eg, rifampin or St. John's Wort) of cytochrome P450 (CYP) 3A4 (within 2 weeks prior to the start of dosing in the study)
- Strong inhibitors (eg, gemfibrozil) or strong inducers (eg, rifampin) of CYP2C8 (within 2 weeks prior to the start of dosing in the study)
- Known P-glycoprotein (P-gp) inhibitors or inducers. Participants 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 PK sampling after the administration of the second 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. Participants 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.
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- Unresolved toxicity from prior chemotherapy (participants must have recovered all significant toxicity to ≤ Grade 1 CTCAE toxicity1 from previous anticancer treatments or previous investigational agents). This does not extend to symptoms or findings that are attributable to the underlying disease
- Received investigational agents within 14 days or 5 half-lives prior to the first study dosing day, whichever is longer
- Women of childbearing potential who are pregnant or breastfeeding
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, clinically significant myocardial infarction within the last 6 months, unstable angina pectoris, clinically significant cardiac arrhythmia, bleeding disorder, chronic pulmonary disease requiring oxygen, or psychiatric illness/social situations that would limit compliance with study requirements
- Major surgery to the upper GI tract, or have a history of GI disease or other medical condition that, in the opinion of the Investigator may interfere with oral drug absorption
- A known history of allergy to paclitaxel. Participants whose allergy was due to the IV solvent (such as Cremophor®) and not paclitaxel will be eligible for this study.
- Any other condition which the Investigator believes would make a subject's participation in the study not acceptable
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
New Zealand3 sites
Auckland City Hospital
Auckland
Dunedin Hospital
Dunedin, 9016
Wellington Regional Hospital
Wellington
Taiwan3 sites
Shuang Ho hospital
New Taipei City
Tri-Service General Hospital
Taipei
Lotung Poh-Ai Hospital
Yilan
About this study
Official title: A Randomized Crossover Study to Determine the Bioequivalence of Three Consecutive Daily Doses of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel
This is a multicenter, open-label, 2-stage study with a 2-treatment period crossover design. Eligible participants are adults with cancer for whom weekly therapy with IV paclitaxel at a dose of 80 mg/m2 over 1 hour is indicated.
Stage 1 will consist of an initial cohort (Cohort 1) up to 6 evaluable participants who will receive a dosing regimen of Oraxol consisting of a 15-mg oral HM30181AK-US tablet plus an oral paclitaxel dose of 205 mg/m2, both administered once daily for 3 consecutive days. The stages and cohorts are further described in the "Study Design - Stages and Cohorts" table below. An interim analysis of pharmacokinetic (PK) data from Cohort 1 will be conducted to determine if the administered regimen would appear likely to achieve bioequivalence(BE) (AUC0-∞), if tested in a greater number of participants in Stage 2. If it appears unlikely that the selected regimen will meet the criteria for BE based on AUC0-∞ data, a second cohort (Cohort 2) of up to 6 evaluable participants may be enrolled in Stage 1, and the dose of paclitaxel in Oraxol may be adjusted by a maximum of +/- 25%. If Cohort 2 is enrolled, a second interim analysis will be conducted.
After the interim analysis/analyses (depending on the outcomes), a decision will be made by consensus of the Data Safety and Monitoring Board(DSMB), Kinex, Zenith Technology, and the Principal Investigator as to what dose should be administered in Stage 2. The DSMB will consist of a clinical oncologist, an ethicist, an independent statistician, and additional members, as deemed necessary. A DSMB charter will describe the planned evaluations and decision points used to determine the dose for Stage 2. An additional 18 to 42 evaluable participants will be enrolled into Stage 2 based on the Stage 1 results (AUC0-∞). Thus a total of up to 54 evaluable participants could potentially be enrolled in this study (6 each from Stage 1, Cohorts 1 and 2, and up to 42 participants in Stage 2).
Read the detailed description
Stage 1 will consist of an initial cohort (Cohort 1) up to 6 evaluable participants who will receive a dosing regimen of Oraxol consisting of a 15-mg oral HM30181AK-US tablet plus an oral paclitaxel dose of 205 mg/m2, both administered once daily for 3 consecutive days. The stages and cohorts are further described in the "Study Design - Stages and Cohorts" table below. An interim analysis of pharmacokinetic (PK) data from Cohort 1 will be conducted to determine if the administered regimen would appear likely to achieve bioequivalence (BE) (AUC0-∞), if tested in a greater number of participants in Stage 2. If it appears unlikely that the selected regimen will meet the criteria for BE based on AUC0-∞ data, a second cohort (Cohort 2) of up to 6 evaluable participants may be enrolled in Stage 1, and the dose of paclitaxel in Oraxol may be adjusted by a maximum of +/- 25%. If Cohort 2 is enrolled, a second interim analysis will be conducted.
After the interim analysis/analyses (depending on the outcomes), a decision will be made by consensus of the Data Safety and Monitoring Board(DSMB), Kinex, Zenith Technology, and the Principal Investigator as to what dose should be administered in Stage 2. The DSMB will consist of a clinical oncologist, an ethicist, an independent statistician, and additional members, as deemed necessary. A DSMB charter will describe the planned evaluations and decision points used to determine the dose for Stage 2. An additional 18 to 42 evaluable participants will be enrolled into Stage 2 based on the Stage 1 results (AUC0-∞). Thus a total of up to 54 evaluable participants could potentially be enrolled in this study (6 each from Stage 1, Cohorts 1 and 2, and up to 42 participants in Stage 2).
- Conditions
- Solid Tumor
- Being tested
- HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM30181 methanesulfonate monohydrate plus oral paclitaxel capsulesDrug
Also called ORAXOL
HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules
Oral paclitaxel capsules
| Study group | Role | What they receive |
|---|---|---|
| Sequence A (Oraxol, IV paclitaxel) | Active comparator | The treatment sequences will be:
A Oraxol (paclitaxel + HM30181) on Days 1, 2, and 3 of Treatment Period 1 followed by IV paclitaxel on Day 1 of Treatment Period 2 B IV paclitaxel on Day 1 of Treatment Period 1 followed by Oraxol on Days 1, 2, and 3 of Treatment Period 2 Receives: Drug: HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules |
| Sequence B (IV paclitaxel, Oraxol) | Active comparator | The treatment sequences will be:
A IV paclitaxel on Day 1 of Treatment Period 1 followed by Oraxol on Days 1, 2, and 3 of Treatment Period 2 B Oraxol (paclitaxel + HM30181) on Days 1, 2, and 3 of Treatment Period 1 followed by IV paclitaxel on Day 1 of Treatment Period 2 Receives: Drug: HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve Zero Time Extrapolated to Infinite Time (AUC0-∞)
Paclitaxel plasma concentrations were normalized to 615 mg/m2 for Oraxol and 80 mg/m2 for IV paclitaxel.
Pharmacokinetic and statistical analyses were based on normalized plasma concentrations. Plasma concentrations for paclitaxel were analyzed to determine AUC0-∞ by noncompartmental analysis using plasma concentration-time data for oral and IV paclitaxel
Measured: Pharmacokinetic Sampling for IV Paclitaxel - Predose to 96 hours after infusion (Day 1-5). Pharmacokinetic Sampling for Oraxol- predose of Day1 to 144 hours after third dose of day 3 (Day 1-9)
Secondary outcomes (5)
Maximum Observed Concentration (Cmax)
Paclitaxel plasma concentrations were normalized to 615 mg/m2 for Oraxol and 80 mg/m2 for IV paclitaxel.
Pharmacokinetic and statistical analyses were based on normalized plasma concentrations. Plasma concentrations for paclitaxel were analyzed to determine Cmax by noncompartmental analysis using plasma concentration-time data for oral and IV paclitaxel
Measured: Pharmacokinetic Sampling for IV Paclitaxel - Predose to 96 hours after infusion (Day 1-5). Pharmacokinetic Sampling for Oraxol- predose of Day1 to 144 hours after third dose of day 3 (Day 1-9)
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-t)
Paclitaxel plasma concentrations were normalized to 615 mg/m2 for Oraxol and 80 mg/m2 for IV paclitaxel.
Pharmacokinetic and statistical analyses were based on normalized plasma concentrations. Plasma concentrations for paclitaxel were analyzed to determine AUC0-t by noncompartmental analysis using plasma concentration-time data for oral and IV paclitaxel
Measured: Pharmacokinetic Sampling for IV Paclitaxel - Predose to 96 hours after infusion (Day 1-5). Pharmacokinetic Sampling for Oraxol- predose of Day1 to 144 hours after third dose of day 3 (Day 1-9)
Time at Which the Highest Drug Concentration Occurs (Tmax)
Paclitaxel plasma concentrations were normalized to 615 mg/m2 for Oraxol and 80 mg/m2 for IV paclitaxel.
Pharmacokinetic and statistical analyses were based on normalized plasma concentrations. Plasma concentrations for paclitaxel were analyzed to determine Tmax by noncompartmental analysis using plasma concentration-time data for oral and IV paclitaxel
Measured: Pharmacokinetic Sampling for IV Paclitaxel - Predose to 96 hours after infusion (Day 1-5). Pharmacokinetic Sampling for Oraxol- predose of Day1 to 144 hours after third dose of day 3 (Day 1-9)
Terminal Elimination Phase Half-life (t½)
Paclitaxel plasma concentrations were normalized to 615 mg/m2 for Oraxol and 80 mg/m2 for IV paclitaxel.
Pharmacokinetic and statistical analyses were based on normalized plasma concentrations. Plasma concentrations for paclitaxel were analyzed to determine t½ by noncompartmental analysis using plasma concentration-time data for oral and IV paclitaxel
Measured: Pharmacokinetic Sampling for IV Paclitaxel - Predose to 96 hours after infusion (Day 1-5). Pharmacokinetic Sampling for Oraxol- predose of Day1 to 144 hours after third dose of day 3 (Day 1-9)
Safety and Tolerability of Oraxol Compared With IV Paclitaxel
Safety was assessed by recording all adverse events (AEs) and serious adverse events (SAEs), including CTCAE grades (version 4.03); recording concomitant medications; clinical laboratory testing (including hematology, biochemistry, and urinalysis); measurement of vital signs (pulse rate, systolic and diastolic blood pressures, respiratory rate, and body temperature), weight, and body surface area (BSA); performance of electrocardiograms (ECGs); assessment of ECOG performance status; and performance of physical examinations
Measured: From screening until final visit (within 28 days after the last dose of study drug was taken, and preferably before the participant receives any additional chemotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 Aug 2015
- Primary completion27 Mar 2019
- Study completion27 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athenex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PharmaEssentia, Zenith Technology Corporation Limited
- Responsible party
- Sponsor
- Investigators
- David Cutler, MD, Study director, Athenex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035473
- Sponsor's protocol ID
- KX-ORAX-002
- Status last verified
- Feb 2022
- First submitted
- 14 Jun 2019
- Last updated
- 13 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Study to Determine the Bioequivalence of Three Consecutive Daily Doses of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel
- ClinicalTrials.gov ID
- NCT04035473
- Acronym / sponsor ID
- KX-ORAX-002
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Athenex, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PharmaEssentia, Zenith Technology Corporation Limited
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Posted 13 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label, 2-stage study with a 2-treatment period crossover design. Eligible participants are adults with cancer for whom weekly therapy with IV paclitaxel at a dose of 80 mg/m2 over 1 hour is indicated.
Stage 1 will consist of an initial cohort (Cohort 1) up to 6 evaluable participants who will receive a dosing regimen of Oraxol consisting of a 15-mg oral HM30181AK-US tablet plus an oral paclitaxel dose of 205 mg/m2, both administered once daily for 3 consecutive days. The stages and cohorts are further described in the "Study Design - Stages and Cohorts" table below. An interim analysis of pharmacokinetic (PK) data from Cohort 1 will be conducted to determine if the administered regimen would appear likely to achieve bioequivalence(BE) (AUC0-∞), if tested in a greater number of participants in Stage 2. If it appears unlikely that the selected regimen will meet the criteria for BE based on AUC0-∞ data, a second cohort (Cohort 2) of up to 6 evaluable participants may be enrolled in Stage 1, and the dose of paclitaxel in Oraxol may be adjusted by a maximum of +/- 25%. If Cohort 2 is enrolled, a second interim analysis will be conducted.
After the interim analysis/analyses (depending on the outcomes), a decision will be made by consensus of the Data Safety and Monitoring Board(DSMB), Kinex, Zenith Technology, and the Principal Investigator as to what dose should be administered in Stage 2. The DSMB will consist of a clinical oncologist, an ethicist, an independent statistician, and additional members, as deemed necessary. A DSMB charter will describe the planned evaluations and decision points used to determine the dose for Stage 2. An additional 18 to 42 evaluable participants will be enrolled into Stage 2 based on the Stage 1 results (AUC0-∞). Thus a total of up to 54 evaluable participants could potentially be enrolled in this study (6 each from Stage 1, Cohorts 1 and 2, and up to 42 participants in Stage 2).
Detailed description
Stage 1 will consist of an initial cohort (Cohort 1) up to 6 evaluable participants who will receive a dosing regimen of Oraxol consisting of a 15-mg oral HM30181AK-US tablet plus an oral paclitaxel dose of 205 mg/m2, both administered once daily for 3 consecutive days. The stages and cohorts are further described in the "Study Design - Stages and Cohorts" table below. An interim analysis of pharmacokinetic (PK) data from Cohort 1 will be conducted to determine if the administered regimen would appear likely to achieve bioequivalence (BE) (AUC0-∞), if tested in a greater number of participants in Stage 2. If it appears unlikely that the selected regimen will meet the criteria for BE based on AUC0-∞ data, a second cohort (Cohort 2) of up to 6 evaluable participants may be enrolled in Stage 1, and the dose of paclitaxel in Oraxol may be adjusted by a maximum of +/- 25%. If Cohort 2 is enrolled, a second interim analysis will be conducted.
After the interim analysis/analyses (depending on the outcomes), a decision will be made by consensus of the Data Safety and Monitoring Board(DSMB), Kinex, Zenith Technology, and the Principal Investigator as to what dose should be administered in Stage 2. The DSMB will consist of a clinical oncologist, an ethicist, an independent statistician, and additional members, as deemed necessary. A DSMB charter will describe the planned evaluations and decision points used to determine the dose for Stage 2. An additional 18 to 42 evaluable participants will be enrolled into Stage 2 based on the Stage 1 results (AUC0-∞). Thus a total of up to 54 evaluable participants could potentially be enrolled in this study (6 each from Stage 1, Cohorts 1 and 2, and up to 42 participants in Stage 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A (Oraxol, IV paclitaxel) | Active comparator | Drug: HM30181 methanesulfonate monohydrate plus oral paclitaxel capsulesThe treatment sequences will be: A Oraxol (paclitaxel + HM30181) on Days 1, 2, and 3 of Treatment Period 1 followed by IV paclitaxel on Day 1 of Treatment Period 2 B IV paclitaxel on Day 1 of Treatment Period 1 followed by Oraxol on Days 1, 2, and 3 of Treatment Period 2 |
| Sequence B (IV paclitaxel, Oraxol) | Active comparator | Drug: HM30181 methanesulfonate monohydrate plus oral paclitaxel capsulesThe treatment sequences will be: A IV paclitaxel on Day 1 of Treatment Period 1 followed by Oraxol on Days 1, 2, and 3 of Treatment Period 2 B Oraxol (paclitaxel + HM30181) on Days 1, 2, and 3 of Treatment Period 1 followed by IV paclitaxel on Day 1 of Treatment Period 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Signed written informed consent
- Males and females ≥18 years of age on day of consent
- Cancer patients for whom treatment with IV paclitaxel at 80 mg/m2has been recommended by their oncologist, either as monotherapy or in combination with other agents
- Adequate hematologic status at Screening/Baseline:
- Adequate liver function at Screening/Baseline as demonstrated by:
Key exclusion criteria (13 listed)
- Currently taking a prohibited concomitant medication:
- Use of warfarin. Participants 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.
- Unresolved toxicity from prior chemotherapy (participants must have recovered all significant toxicity to ≤ Grade 1 CTCAE toxicity1 from previous anticancer treatments or previous investigational agents). This does not extend to symptoms or findings that are attributable to the underlying disease
- Received investigational agents within 14 days or 5 half-lives prior to the first study dosing day, whichever is longer
- Women of childbearing potential who are pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HM30181 methanesulfonate monohydrate plus oral paclitaxel capsulesAlso: ORAXOLHM30181 methanesulfonate monohydrate plus oral paclitaxel capsules Oral paclitaxel capsules | Drug | Sequence A (Oraxol, IV paclitaxel), Sequence B (IV paclitaxel, Oraxol) |
Primary outcome
Area Under the Concentration-Time Curve Zero Time Extrapolated to Infinite Time (AUC0-∞)
Time frame: Pharmacokinetic Sampling for IV Paclitaxel - Predose to 96 hours after infusion (Day 1-5). Pharmacokinetic Sampling for Oraxol- predose of Day1 to 144 hours after third dose of day 3 (Day 1-9)
Paclitaxel plasma concentrations were normalized to 615 mg/m2 for Oraxol and 80 mg/m2 for IV paclitaxel. Pharmacokinetic and statistical analyses were based on normalized plasma concentrations. Plasma concentrations for paclitaxel were analyzed to determine AUC0-∞ by noncompartmental analysis using plasma concentration-time data for oral and IV paclitaxel
5 secondary outcomes
Maximum Observed Concentration (Cmax)
Time frame: Pharmacokinetic Sampling for IV Paclitaxel - Predose to 96 hours after infusion (Day 1-5). Pharmacokinetic Sampling for Oraxol- predose of Day1 to 144 hours after third dose of day 3 (Day 1-9)
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-t)
Time frame: Pharmacokinetic Sampling for IV Paclitaxel - Predose to 96 hours after infusion (Day 1-5). Pharmacokinetic Sampling for Oraxol- predose of Day1 to 144 hours after third dose of day 3 (Day 1-9)
Time at Which the Highest Drug Concentration Occurs (Tmax)
Time frame: Pharmacokinetic Sampling for IV Paclitaxel - Predose to 96 hours after infusion (Day 1-5). Pharmacokinetic Sampling for Oraxol- predose of Day1 to 144 hours after third dose of day 3 (Day 1-9)
Terminal Elimination Phase Half-life (t½)
Time frame: Pharmacokinetic Sampling for IV Paclitaxel - Predose to 96 hours after infusion (Day 1-5). Pharmacokinetic Sampling for Oraxol- predose of Day1 to 144 hours after third dose of day 3 (Day 1-9)
Safety and Tolerability of Oraxol Compared With IV Paclitaxel
Time frame: From screening until final visit (within 28 days after the last dose of study drug was taken, and preferably before the participant receives any additional chemotherapy)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Cutler, MD study director
Athenex, Inc.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules in people with Solid Tumor, run by Athenex, Inc. at 7 sites in 3 countries.
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 13 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 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in New Zealand, Taiwan, Australia. 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 13 Apr 2022). 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?
Area Under the Concentration-Time Curve Zero Time Extrapolated to Infinite Time (AUC0-∞) (time frame: Pharmacokinetic Sampling for IV Paclitaxel - Predose to 96 hours after infusion (Day 1-5). Pharmacokinetic Sampling for Oraxol- predose of Day1 to 144 hours after third dose of day 3 (Day 1-9)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2022.