- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03165955
A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Taichung, Taiwan, 40447
- China Medical University Hospital
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Taipei, Taiwan, 110
- Taipei Medical University Hospital
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Taipei, Taiwan, 114
- Tri-Service General Hospital
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Taipei, Taiwan, 23561
- Shuang Ho Hospital
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Taipei, Taiwan, 10048
- National Taiwan University Hospital
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Taipei, Taiwan, 11217
- Taipei Veterans Generla Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed written informed consent
- Women ≥18 years of age on day of consent
- Breast cancer in patients for whom treatment with IV paclitaxel at 80 mg/m2 as monotherapy has been recommended by their oncologist
- Measurable disease as per RECIST v1.1 criteria
Adequate hematological status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) maintain:
- Absolute neutrophil count (ANC) ≥1.5 x 10^9/L
- Platelet count ≥100 x 10^9/L
- Hemoglobin (Hgb) ≥9 g/dL
Adequate liver function
- Total bilirubin of ≤1.5 mg/dL
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) or ≤5 x ULN if liver metastasis is present
- Alkaline phosphatase (ALP) ≤3 x ULN or ≤5 x ULN if bone metastasis is present
- Gamma glutamyl transferase (GGT) <10 x ULN
- Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Willing to fast for 6 hours before and 2 hours after Oraxol administration on all treatment days
- Willing to abstain from alcohol consumption for 3 days before the first dose of study drug through the completion of the second inpatient PK sampling period
- Willing to refrain from caffeine consumption for 12 hours before each inpatient dosing period through the completion of protocol-specified PK sampling for that week
- Subjects must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after their last dose of assigned study treatment.
- Subjects who are of childbearing potential must have a negative serum pregnancy test at Screening and within 96 hours before dosing.
Exclusion Criteria:
- Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
- If previously treated with a taxane (paclitaxel or docetaxel) as part of anthracycline-based adjuvant chemotherapy or for metastatic disease, the subject relapsed less than 1 year following treatment
- Subjects unable to swallow study medication in its intact form or have clinically significant malabsorption syndrome
- Only site of metastatic disease is unmeasurable according to RECIST v1.1 criteria
- Known CNS metastasis, including leptomeningeal involvement
- Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
- Are currently receiving other medications intended for the treatment of their malignancy
- Women who are pregnant or breastfeeding
- Taking prohibited medications:
- Use of warfarin. Subjects receiving warfarin who are otherwise eligible and who may be appropriately managed with low molecular weight heparin, in the opinion of the Investigator, may be enrolled in the study provided they are switched to low molecular weight heparin at least 7 days prior to receiving study treatment.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease requiring oxygen, known bleeding disorders, or any concomitant illness or social situation that would limit compliance with study requirements
- Known allergic reaction or intolerance to study medication components
- Known allergic reaction or intolerance to contrast media
- Subjects who, in the Investigator's opinion, are not suitable for participation in this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Oraxol
Subjects will receive Oraxol 205 mg/m2 daily x 3 days weekly for up to 16 weeks.
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HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets, Paclitaxel - supplied as 30-mg capsules
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PK Parameters for paclitaxel_AUC (0-52)
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
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PK parameters were summarized using the mean, SD
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PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
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PK Parameters for paclitaxel_Cmax
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
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PK parameters were summarized using the mean, SD
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PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
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PK Parameters for paclitaxel_Ctrough(24)
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
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PK parameters were summarized using the mean, SD
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PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
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PK Parameters for paclitaxel_Ctrough(48)
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
|
PK parameters were summarized using the mean, SD
|
PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
|
PK Parameters for paclitaxel_Cmax(0-24)
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
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PK parameters were summarized using the mean, SD
|
PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
|
PK Parameters for paclitaxel_Cmax(24-48)
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
|
PK parameters were summarized using the mean, SD
|
PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
|
PK Parameters for paclitaxel_Cmax(48-52)
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
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PK parameters were summarized using the mean, SD
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PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
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PK Parameters for paclitaxel_tmax(0-24)
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
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PK parameters were summarized using the median, minimum, maximum
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PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
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PK Parameters for paclitaxel_tmax(24-48)
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
|
PK parameters were summarized using the median, minimum, maximum
|
PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
|
PK Parameters for paclitaxel_tmax(48-52)
Time Frame: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
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PK parameters were summarized using the median, minimum, maximum
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PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of Oraxol in Breast Cancer Patients
Time Frame: From enrollment through study completion, approximately 17 weeks
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Safety was assessed by evaluating treatment-emergent adverse events (TEAEs) including SAEs, laboratory evaluations (hematology, blood chemistry, and urinalysis), vital signs, physical examinations, and electrocardiograms (ECGs).
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From enrollment through study completion, approximately 17 weeks
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Response Rate
Time Frame: From baseline through study completion, around 21 weeks
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Tumor response rate and 95% confidence interval (CI) were evaluated based on the number of subjects with any post-baseline CR or PR per RECIST 1.1 as assessed by the Investigator and the ICRRC.
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From baseline through study completion, around 21 weeks
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Progression-free Survival
Time Frame: From baseline through study completion, around 21 weeks
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PFS was analyzed based on the Response Evaluable Population. The Kaplan-Meier (KM) method was used to estimate the medians of these variables with 95% CIs. The Response Evaluable Population included all subjects who received at least 1 dose of study treatment and had at least 1 posttreatment tumor response evaluation |
From baseline through study completion, around 21 weeks
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Overall Survival
Time Frame: From baseline through study completion, around 21 weeks
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OS was analyzed based on the Response Evaluable Population. The Kaplan-Meier (KM) method was used to estimate the medians of these variables with 95% CIs. The Response Evaluable Population included all subjects who received at least 1 dose of study treatment and had at least 1 posttreatment tumor response evaluation |
From baseline through study completion, around 21 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tsu-Yi Chao, MD, DMS, PhD, Taipei Medical University Shuang Ho Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KX-ORAX-007
- U1111-1176-4228 (OTHER: ICTRP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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