BreastcancerPhase 1NCT04168957
An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007
A Phase 1 study testing Oraxol in people with Breastcancer, run by Athenex, Inc. at 5 sites in Taiwan.
Trial summary
KX-ORAX-008 is an extension study of patients who completed KX-ORAX-007 without disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and who wish to continue Oraxol treatment. 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
- 11 participants
- Where
- 5 sitesTaiwan
- Study dates
- 25 Oct 2017to 12 Nov 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
- Breast cancer patients who have completed Study KX-ORAX-007 without disease progression at Week 16, who wish to continue Oraxol treatment.
- Signed written informed consent.
- Willing to fast for 6 hours before and 2 hours after Oraxol administration on all treatment days.
- Patients 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.
Who cannot join
- Have not recovered from unacceptable toxicity associated with previous Oraxol treatment in KX-ORAX-007.
- Are currently receiving other medications intended for the treatment of their malignancy.
- Women who are pregnant or breastfeeding.
- Taking any following prohibited medications:
- Strong inhibitors (eg, ketoconazole) or strong 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 strong inducers (eg, rifampin) of CYP2C8 (within 2 weeks prior to the start of dosing in the study).
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- Strong P-gp inhibitors or inducers.
- 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. Patients 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.
- Patients who, in the Investigator's opinion, are not suitable for participation in this study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561
China Medical University Hospital
Taichung
Taipei Medical University Hospital
Taipei
Tr-Service General Hospital
Taipei
Taipei Veterans Generla Hospital
Taipei, Taiwan, 11217
About this study
KX-ORAX-008 is an extension study of patients who completed KX-ORAX-007 without disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and who wish to continue Oraxol treatment.
Read the detailed description
This is a multicenter, open-label, extension study offering the option of further Oraxol treatment to breast cancer patients who have completed the KX-ORAX-007 Oraxol study with complete response (CR), partial response (PR), or stable disease (SD), and who wish to continue further Oraxol treatment. The study contains 3 periods: the Screening Period, the Treatment Period, and the Follow-up Period. A Final Visit will occur within 7 days of the last dose of study treatment.
- Conditions
- Breastcancer
- Being tested
- Oraxol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraxolDrug
Oraxol (oral paclitaxel + oral HM30181AK-US)
Paclitaxel: supplied as capsules HM30181 methanesulfonate monohydrate: supplied as HM30181AK-US tablets
| Study group | Role | What they receive |
|---|---|---|
| Oraxol | Experimental | Subjects in KX-ORAX-008 will begin treatment at the last oral paclitaxel dose they received in Study KX-ORAX-007. Receives: Drug: Oraxol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety assessments will consist of determining and recording all adverse events and SAEs (adverse events will be graded on a 5-point scale according to CTCAE v4.03); Evaluate the safety of Oraxol. Number of participants with treatment-related adverse events.
Measured: From screening until final visit (within 72 hours prior to Day 21 of Study Period 2, preferably before the participant receives any additional chemotherapy)
Secondary outcomes (1)
Activity: Tumor response
The number of patients with CR or PR at any post-baseline assessments after the start of treatment in KX-ORAX-007. Computed tomography (CT) and/or magnetic resonance imaging (MRI) scans will be conducted on Day 1 every 8 weeks until documented progression. Tumor status will be evaluated using RECIST v1.1 criteria. In addition to using the RECIST criteria, the Investigator must consider all other clinical information as part of tumor status evaluation.
Measured: from the start of treatment in KX-ORAX-007 until follow up visit every 2 months after patient withdrawal up to 10 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start25 Oct 2017
- Primary completion27 Aug 2019
- Study completion12 Nov 2020
Why it stopped: No need to complete the overall survival (OS) follow-up as the sample size was too small to interpret OS.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastcancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athenex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PharmaEssentia
- Responsible party
- Sponsor
- Investigators
- David Cutler, MD, Study director, Athenex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168957
- Sponsor's protocol ID
- KX-ORAX-008
- Other IDs
- U1111-1180-5217
- Status last verified
- Feb 2022
- First submitted
- 13 Apr 2018
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007
- ClinicalTrials.gov ID
- NCT04168957
- Acronym / sponsor ID
- KX-ORAX-008
- Conditions
- Breastcancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No need to complete the overall survival (OS) follow-up as the sample size was too small to interpret OS.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Athenex, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PharmaEssentia
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 27 Aug 2019 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 19 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.
KX-ORAX-008 is an extension study of patients who completed KX-ORAX-007 without disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and who wish to continue Oraxol treatment.
Detailed description
This is a multicenter, open-label, extension study offering the option of further Oraxol treatment to breast cancer patients who have completed the KX-ORAX-007 Oraxol study with complete response (CR), partial response (PR), or stable disease (SD), and who wish to continue further Oraxol treatment. The study contains 3 periods: the Screening Period, the Treatment Period, and the Follow-up Period. A Final Visit will occur within 7 days of the last dose of study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oraxol | Experimental | Drug: OraxolSubjects in KX-ORAX-008 will begin treatment at the last oral paclitaxel dose they received in Study KX-ORAX-007. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Breast cancer patients who have completed Study KX-ORAX-007 without disease progression at Week 16, who wish to continue Oraxol treatment.
- Signed written informed consent.
- Willing to fast for 6 hours before and 2 hours after Oraxol administration on all treatment days.
- Patients 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.
Key exclusion criteria (13 listed)
- Have not recovered from unacceptable toxicity associated with previous Oraxol treatment in KX-ORAX-007.
- Are currently receiving other medications intended for the treatment of their malignancy.
- Women who are pregnant or breastfeeding.
- Taking any following prohibited medications:
- Use of warfarin. Patients 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.
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 |
|---|---|---|
| OraxolOraxol (oral paclitaxel + oral HM30181AK-US) Paclitaxel: supplied as capsules HM30181 methanesulfonate monohydrate: supplied as HM30181AK-US tablets | Drug | Oraxol |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From screening until final visit (within 72 hours prior to Day 21 of Study Period 2, preferably before the participant receives any additional chemotherapy)
Safety assessments will consist of determining and recording all adverse events and SAEs (adverse events will be graded on a 5-point scale according to CTCAE v4.03); Evaluate the safety of Oraxol. Number of participants with treatment-related adverse events.
1 secondary outcome
Activity: Tumor response
Time frame: from the start of treatment in KX-ORAX-007 until follow up visit every 2 months after patient withdrawal up to 10 months.
Results and safety
The study was stopped early (reason given: No need to complete the overall survival (OS) follow-up as the sample size was too small to interpret OS.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
5 sites in 1 country: see every site and its status.
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 5 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 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: stopped early, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No need to complete the overall survival (OS) follow-up as the sample size was too small to interpret OS.). Results are not available in the source record.
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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: From screening until final visit (within 72 hours prior to Day 21 of Study Period 2, 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 3 Mar 2022.