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CompletedNCT04035473Updated Apr 13, 2022Results posted

A Study to Determine the Bioequivalence of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel

A Phase 1 interventional study of HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules in Solid Tumor, sponsored by Athenex, Inc.. Completed at 7 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-13.

Sponsored by Athenex, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 10 months after the study started (first participant enrolled Aug 2015, registered Jun 2019).
Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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).

02

Conditions studied

  • Solid Tumor
03

In context

Lead sponsor

Athenex, Inc. is the lead sponsor of 21 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Signed written informed consent
  2. Males and females ≥18 years of age on day of consent
  3. 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

  4. Adequate hematologic status at Screening/Baseline:

    • Absolute neutrophil count (ANC) ≥1.5 x 109/L
    • Platelet count ≥100 x 109/L
    • Hemoglobin (Hgb) ≥90 g/L

  5. 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
  6. 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
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 16
  8. Life expectancy of at least 3 months
  9. Willing to fast for 8 hours before and 4 hours after Oraxol administration
  10. 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
  11. Willing to refrain from caffeine consumption for 12 hours before each treatment period through the completion of protocol-specified PK sampling for that dose
  12. 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.
  13. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. 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.
  3. 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
  4. Received investigational agents within 14 days or 5 half-lives prior to the first study dosing day, whichever is longer
  5. Women of childbearing potential who are pregnant or breastfeeding
  6. 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
  7. 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
  8. 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.
  9. Any other condition which the Investigator believes would make a subject's participation in the study not acceptable
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Active comparator
    Sequence A (Oraxol, IV paclitaxel)

    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

    Drug: HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules

  • Active comparator
    Sequence B (IV paclitaxel, Oraxol)

    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

    Drug: HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules

Interventions

  • DrugHM30181 methanesulfonate monohydrate plus oral paclitaxel capsules

    HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules Oral paclitaxel capsules

    Also known as: ORAXOL

06

What researchers measure

Primary outcomes

  1. 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

    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)

Secondary outcomes

  1. 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

    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)

  2. 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

    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)

  3. 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

    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)

  4. 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

    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)

  5. 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

    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)

07

Results

Posted Apr 13, 2022

Participant flow

Screening/Baseline
Participant flow — Screening/Baseline
MilestoneSequence A (Oraxol, IV Paclitaxel)Sequence B (IV Paclitaxel, Oraxol)
Started2022
Completed2020
Not completed02
Withdrew: Death01
Withdrew: Adverse event01
Treatment Period 1
Participant flow — Treatment Period 1
MilestoneSequence A (Oraxol, IV Paclitaxel)Sequence B (IV Paclitaxel, Oraxol)
Started2020
Completed2020
Not completed00
Treatment Period 2
Participant flow — Treatment Period 2
MilestoneSequence A (Oraxol, IV Paclitaxel)Sequence B (IV Paclitaxel, Oraxol)
Started1819
Completed1819
Not completed00
Follow-up Period
Participant flow — Follow-up Period
MilestoneSequence A (Oraxol, IV Paclitaxel)Sequence B (IV Paclitaxel, Oraxol)
Started1819
Completed1619
Not completed20
Withdrew: Adverse event20

Outcome measures

PrimaryArea 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

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)
Reported as:
Mean · ng*h/mL
Area Under the Concentration-Time Curve Zero Time Extrapolated to Infinite Time (AUC0-∞)
ng*h/mLOraxolIV Paclitaxel
Area Under the Concentration-Time Curve Zero Time Extrapolated to Infinite Time (AUC0-∞)5033.5 ± 1401.15595.9 ± 264.1
SecondaryMaximum 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

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)
Reported as:
Mean · ng/mL
Maximum Observed Concentration (Cmax)
ng/mLOraxolIV Paclitaxel
Maximum Observed Concentration (Cmax)397.2 ± 157.32732.8 ± 629.7
SecondaryArea 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

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)
Reported as:
Mean · ng*h/mL
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-t)
ng*h/mLOraxolIV Paclitaxel
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-t)4829.4 ± 1375.15431.8 ± 1200.3
SecondaryTime 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

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)
Reported as:
Mean · hours
Time at Which the Highest Drug Concentration Occurs (Tmax)
hoursOraxolIV Paclitaxel
Time at Which the Highest Drug Concentration Occurs (Tmax)1.4 ± 0.61.0 ± 0.2
SecondaryTerminal 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

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)
Reported as:
Mean · hours
Terminal Elimination Phase Half-life (t½)
hoursOraxolIV Paclitaxel
Terminal Elimination Phase Half-life (t½)42.8 ± 8.626.1 ± 4.3
SecondarySafety 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

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)
Reported as:
Count of participants · Participants
Safety and Tolerability of Oraxol Compared With IV Paclitaxel
ParticipantsOraxolIV Paclitaxel
TEAE3629
Treatment-related TEAE3020
Grade 3 TEAE72
TEAE leading to study drug discontinuation12
TEAE leading to study discontinuation02
TEAE resulting in death01

Adverse events

Collected over up to 7 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Oraxol0/39 (0%)4/39 (10.3%)36/39 (92.3%)
IV Paclitaxel1/38 (2.6%)2/38 (5.3%)29/38 (76.3%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventOraxolIV Paclitaxel
Septic shockInfections and infestations0/391/38
VomitingGastrointestinal disorders0/391/38
Altered state of consciousnessNervous system disorders0/391/38
Atrial fibrillationCardiac disorders1/390/38
Cardiac tamponadeCardiac disorders1/390/38
TachycardiaCardiac disorders1/390/38
Lower respiratory tract infectionInfections and infestations1/390/38
NeutropeniaBlood and lymphatic system disorders1/390/38
HaematuriaRenal and urinary disorders1/390/38
DyspnoeaRespiratory, thoracic and mediastinal disorders1/390/38
Most frequent other events
Showing 10 of 74
Most frequent other events
EventOraxolIV Paclitaxel
DiarrhoeaGastrointestinal disorders11/397/38
NauseaGastrointestinal disorders11/393/38
FatigueGeneral disorders6/392/38
FlushingVascular disorders0/395/38
VomitingGastrointestinal disorders5/391/38
HeadacheNervous system disorders3/392/38
CoughRespiratory, thoracic and mediastinal disorders3/391/38
DyspepsiaGastrointestinal disorders2/392/38
Abdominal pain upperGastrointestinal disorders0/392/38
HypoaesthesiaNervous system disorders1/392/38

Baseline characteristics

Of the 42 randomized subjects, 2 discontinued study participation due to an AE prior to receiving study drug

Age, Continuous
Age, Continuous(years)Sequence A (Oraxol, IV Paclitaxel)Sequence B (IV Paclitaxel, Oraxol)Total
Mean60.8 ± 10.1259.85 ± 12.1460.33 ± 11.04
Sex: Female, Male
Sex: Female, Male(Participants)Sequence A (Oraxol, IV Paclitaxel)Sequence B (IV Paclitaxel, Oraxol)Total
Female131326
Male7714
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Sequence A (Oraxol, IV Paclitaxel)Sequence B (IV Paclitaxel, Oraxol)Total
American Indian or Alaska Native101
Asian4610
Native Hawaiian or Other Pacific Islander000
Black or African American000
White151429
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Sequence A (Oraxol, IV Paclitaxel)Sequence B (IV Paclitaxel, Oraxol)Total
New Zealand151530
Taiwan358
Australia202
Weight
Weight(kg)Sequence A (Oraxol, IV Paclitaxel)Sequence B (IV Paclitaxel, Oraxol)Total
Mean70.89 ± 15.4575.42 ± 15.3273.16 ± 15.36
Height
Height(cm)Sequence A (Oraxol, IV Paclitaxel)Sequence B (IV Paclitaxel, Oraxol)Total
Mean166.13 ± 8.50166.05 ± 7.82166.09 ± 8.06
Body Surface Area
Body Surface Area(m^2)Sequence A (Oraxol, IV Paclitaxel)Sequence B (IV Paclitaxel, Oraxol)Total
Mean1.78 ± 0.201.84 ± 0.201.81 ± 0.20
ECOG
ECOG(Participants)Sequence A (Oraxol, IV Paclitaxel)Sequence B (IV Paclitaxel, Oraxol)Total
081220
112820
2000
3000
4000
5000

2 further baseline measures are reported on the registry.

08

Study locations

7 sites
  • Monash Medical Centre
    Melbourne, Australia
  • Auckland City Hospital
    Auckland, New Zealand
  • Dunedin Hospital
    Dunedin, 9016, New Zealand
  • Wellington Regional Hospital
    Wellington, New Zealand
  • Lotung Poh-Ai Hospital
    Ilan, Taiwan
  • Shuang Ho hospital
    New Taipei City, Taiwan
  • Tri-Service General Hospital
    Taipei, Taiwan
09

References and documents

Study documents

  • Study protocol · Nov 9, 2017
  • Statistical analysis plan · Sep 17, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04035473
Lead sponsor
Athenex, Inc.
Collaborators
PharmaEssentia, Zenith Technology Corporation Limited
Responsible party
Sponsor
First posted
Jul 29, 2019
Start date
Aug 1, 2015
Primary completion
Mar 27, 2019
Completion
Mar 27, 2019
Results posted
Apr 13, 2022
Last update
Apr 13, 2022

Study contacts

David Cutler, MD
study director · Athenex, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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