Solid TumorPhase 2NCT04180384
A Safety Study of Oraxol (HM30181 + Oral Paclitaxel) in Cancer Patients
A Phase 2 study testing Oraxol in people with Solid Tumor, run by Athenex, Inc. at 8 sites in 4 countries.
Trial summary
Oraxol is a combination of an oral tablet, HM30181 methanesulfonate, and capsules that contain paclitaxel. HM30181 is a drug that helps the body absorb paclitaxel, a drug used to treat cancer. 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?
- Oraxol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 23 Sep 2015to 15 Jun 2021
- Phase
- Phase 2
- 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
- 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/m2 has been recommended by their oncologist, either as monotherapy or in combination with other agents
- Adequate hematologic status:
- Absolute neutrophil count (ANC) ≥1.5 x 10^9/L
- Platelet count ≥100 x 10^9/L
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- Hemoglobin (Hgb) ≥90 g/L
- Adequate liver function 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 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 on all treatment days (but may have water 1 hour after completion of Oraxol dosing and as needed with other prescribed medications)
- During the inpatient PK sampling week(s):
- Willing to abstain from alcohol consumption for 3 days before the first dose of Oraxol through the completion of protocol-specified PK sampling for that treatment week
- Willing to refrain from caffeine consumption for 12 hours before the first dose of Oraxol through the completion of protocol-specified PK sampling for that treatment week
- Women must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or, if of childbearing potential, 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 6 months 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 6 months 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)
- Strong P-gp inhibitors (eg, verapamil) or strong inducers (eg, rifampin). 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 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 toxicity 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
8 sites in 4 countries.
8 sites in 4 countries
New Zealand3 sites
Auckland City Hospital
Auckland
Dunedin Hospital
Dunedin
Wellington Regional Hospital
Wellington
Taiwan3 sites
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561
Tri-Service General Hospital
Taipei, 114
Lotung Poh-Ai Hospital
Yilan
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
Oraxol is a combination of an oral tablet, HM30181 methanesulfonate, and capsules that contain paclitaxel. HM30181 is a drug that helps the body absorb paclitaxel, a drug used to treat cancer. Initially this study is intended as an extension study of KX-ORAX-002 pharmacokinetic study for patients who wish to continue Oraxol treatment and who are eligible to participate. The purpose of this study is to check the safety and tolerability of Oraxol when it is administered on a weekly basis and to confirm the sustained oral bioavailability of paclitaxel following multiple dosing; also compare the relative bioavailability of paclitaxel tablets vs paclitaxel capsules (Group B only).
Read the detailed description
Oraxol is a combination of an oral tablet, HM30181 methanesulfonate, and capsules that contain paclitaxel. HM30181 is a drug that helps the body absorb paclitaxel, a drug used to treat cancer. Initially this study is intended as an extension study of KX-ORAX-002 pharmacokinetic study for patients who wish to continue Oraxol treatment and who are eligible to participate. Once the dose of Oraxol has been confirmed in the KX-ORAX-002 study, then enrollment of patients who have not participated in the KX-ORAX-002 study can be allowed. The purpose of this study is to check the safety and tolerability of Oraxol when it is administered on a weekly basis and to confirm the sustained oral bioavailability of paclitaxel following multiple dosing; also compare the relative bioavailability of paclitaxel tablets vs paclitaxel capsules (Group B only). Participants in Group B (N=8) will receive the same weekly paclitaxel capsule treatment as the remainder of the subjects except for 1 dosing week (at least 1 week following the paclitaxel capsule PK sampling period) during which they will receive paclitaxel tablets and undergo PK assessments.
- Conditions
- Solid Tumor
- Being tested
- Oraxol
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, Oral paclitaxel tablets
Paclitaxel:
5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13- ester with (2R,3S)-N-benzoyl-3-phenylisoserine
HM30181 methanesulfonate monohydrate:
N-(2-(2-(4-(2-(6,7-Dimethoxy-3,4-dihydroisoquinolin-2(1H)-yl)ethyl)phenyl)-2H-tetrazol-5-yl)-4,5-dimethoxyphenyl)-4-oxo-4H-chromene-2-carboxamide Methanesulfonate monohydrate
| Study group | Role | What they receive |
|---|---|---|
| Oraxol (paclitaxel capsules+ HM30181AK-US) | Experimental | Oraxol paclitaxel - supplied as 30-mg capsules
Oraxol HM30181 methansulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets Receives: Drug: Oraxol |
| Oraxol (paclitaxel tablets+ HM30181AK-US) | Active comparator | Oraxol paclitaxel - supplied as 30-mg tablets
Oraxol HM30181 methansulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets Receives: Drug: Oraxol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of Oraxol (Incidence of Treatment-Emergent Adverse Events)
Safety and tolerability as assessed by the incidence of adverse events. Treatment-emergent AEs (TEAEs) are defined as those AEs with an onset after dosing and those pre-existing AEs that worsen during the study.
AEs will include those reported by participants as well as those observed by the clinical team, or clinically significant changes in lab tests, vital signs and ECGs. Possible AEs may include gastrointestinal effects and abdominal pain but as this is an early phase clinical trial and the likely AE profile is not yet known.
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).
Secondary outcomes (2)
Sustained oral bioavailability of paclitaxel following multiple dosing
Oraxol PK data from this study will be compared with Oraxol PK data from study KX-ORAX-002.
Measured: PK samples will be collected during dosing for Week 4 or may be done during a later dosing week at the investigator's discretion and/or at the participant's convenience before patients' withdrawal from the study, up to 8 months.
the relative bioavailability of paclitaxel tablets vs paclitaxel capsules (Group B only)
For Group B, 8 subjects will be enrolled and the geometric mean ratio (GMR) will be calculated comparing the Cmax and AUC0-∞ of the tablet and capsule formulations of paclitaxel following oral administration.
Measured: PK samples will be collected during dosing for Week 5; or may be done during a later dosing week at the investigator's discretion and/or at the participant's convenience, up to 8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start23 Sep 2015
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- For 1 dosing week (at least 1 week following the paclitaxel capsule PK sampling period, ie, at Week 5 or later), a subgroup of 8 participants (Group B) will receive Oraxol as HM30181 plus a tablet formulation of paclitaxel. For the remainder of the study, Group B participants will receive the current clinical capsule formulation of paclitaxel. This will allow for comparison of the bioavailability of these 2 formulations with minimal impact on safety or activity.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athenex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zenith Technology Corporation Limited, PharmaEssentia
- Responsible party
- Sponsor
- Investigators
- Jackson Christopher, MD, Principal investigator, Dunedin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180384
- Sponsor's protocol ID
- KX-ORAX-003
- Status last verified
- May 2021
- First submitted
- 13 Jun 2019
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Study of Oraxol (HM30181 + Oral Paclitaxel) in Cancer Patients
- ClinicalTrials.gov ID
- NCT04180384
- Acronym / sponsor ID
- KX-ORAX-003
- Conditions
- Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Athenex, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Zenith Technology Corporation Limited, PharmaEssentia
- Study start
- 23 Sep 2015 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oraxol is a combination of an oral tablet, HM30181 methanesulfonate, and capsules that contain paclitaxel. HM30181 is a drug that helps the body absorb paclitaxel, a drug used to treat cancer. Initially this study is intended as an extension study of KX-ORAX-002 pharmacokinetic study for patients who wish to continue Oraxol treatment and who are eligible to participate. The purpose of this study is to check the safety and tolerability of Oraxol when it is administered on a weekly basis and to confirm the sustained oral bioavailability of paclitaxel following multiple dosing; also compare the relative bioavailability of paclitaxel tablets vs paclitaxel capsules (Group B only).
Detailed description
Oraxol is a combination of an oral tablet, HM30181 methanesulfonate, and capsules that contain paclitaxel. HM30181 is a drug that helps the body absorb paclitaxel, a drug used to treat cancer. Initially this study is intended as an extension study of KX-ORAX-002 pharmacokinetic study for patients who wish to continue Oraxol treatment and who are eligible to participate. Once the dose of Oraxol has been confirmed in the KX-ORAX-002 study, then enrollment of patients who have not participated in the KX-ORAX-002 study can be allowed. The purpose of this study is to check the safety and tolerability of Oraxol when it is administered on a weekly basis and to confirm the sustained oral bioavailability of paclitaxel following multiple dosing; also compare the relative bioavailability of paclitaxel tablets vs paclitaxel capsules (Group B only). Participants in Group B (N=8) will receive the same weekly paclitaxel capsule treatment as the remainder of the subjects except for 1 dosing week (at least 1 week following the paclitaxel capsule PK sampling period) during which they will receive paclitaxel tablets and undergo PK assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For 1 dosing week (at least 1 week following the paclitaxel capsule PK sampling period, ie, at Week 5 or later), a subgroup of 8 participants (Group B) will receive Oraxol as HM30181 plus a tablet formulation of paclitaxel. For the remainder of the study, Group B participants will receive the current clinical capsule formulation of paclitaxel. This will allow for comparison of the bioavailability of these 2 formulations with minimal impact on safety or activity.
| Arm | Type | Receives |
|---|---|---|
| Oraxol (paclitaxel capsules+ HM30181AK-US) | Experimental | Drug: OraxolOraxol paclitaxel - supplied as 30-mg capsules Oraxol HM30181 methansulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets |
| Oraxol (paclitaxel tablets+ HM30181AK-US) | Active comparator | Drug: OraxolOraxol paclitaxel - supplied as 30-mg tablets Oraxol HM30181 methansulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 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/m2 has been recommended by their oncologist, either as monotherapy or in combination with other agents
- Adequate hematologic status:
- Adequate liver function 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 toxicity 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 |
|---|---|---|
| OraxolAlso: HM30181 methanesulfonate monohydrate, Oral paclitaxel capsules, Oral paclitaxel tabletsPaclitaxel: 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13- ester with (2R,3S)-N-benzoyl-3-phenylisoserine HM30181 methanesulfonate monohydrate: N-(2-(2-(4-(2-(6,7-Dimethoxy-3,4-dihydroisoquinolin-2(1H)-yl)ethyl)phenyl)-2H-tetrazol-5-yl)-4,5-dimethoxyphenyl)-4-oxo-4H-chromene-2-carboxamide Methanesulfonate monohydrate | Drug | Oraxol (paclitaxel capsules+ HM30181AK-US), Oraxol (paclitaxel tablets+ HM30181AK-US) |
Primary outcome
Safety and tolerability of Oraxol (Incidence of Treatment-Emergent Adverse Events)
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).
Safety and tolerability as assessed by the incidence of adverse events. Treatment-emergent AEs (TEAEs) are defined as those AEs with an onset after dosing and those pre-existing AEs that worsen during the study. AEs will include those reported by participants as well as those observed by the clinical team, or clinically significant changes in lab tests, vital signs and ECGs. Possible AEs may include gastrointestinal effects and abdominal pain but as this is an early phase clinical trial and the likely AE profile is not yet known.
2 secondary outcomes
Sustained oral bioavailability of paclitaxel following multiple dosing
Time frame: PK samples will be collected during dosing for Week 4 or may be done during a later dosing week at the investigator's discretion and/or at the participant's convenience before patients' withdrawal from the study, up to 8 months.
the relative bioavailability of paclitaxel tablets vs paclitaxel capsules (Group B only)
Time frame: PK samples will be collected during dosing for Week 5; or may be done during a later dosing week at the investigator's discretion and/or at the participant's convenience, up to 8 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Jackson Christopher, MD principal investigator
Dunedin Hospital
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oraxol in people with Solid Tumor, run by Athenex, Inc. at 8 sites in 4 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 22 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 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in New Zealand, Taiwan, Australia, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety and tolerability of Oraxol (Incidence of Treatment-Emergent Adverse Events) (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).). 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 29 Jul 2021.