Clinical Trials List
Protocol NumberKX-ORAX-007
NCT Number(ClinicalTrials.gov Identfier)NCT03165955
2016-04-01 - 2018-12-31
Phase I
Terminated6
ICD-10C50
Malignant neoplasm of breast
ICD-10C79.81
Secondary malignant neoplasm of breast
A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients
-
Trial Applicant
-
Sponsor
PharmaEssentia
-
Trial scale
Taiwan Multiple Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Ling-Ming Tseng Division of General Surgery
- Chun-Yu Liu Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
5 Stop recruiting
Audit
None
Co-Principal Investigator
- JHE-CYUAN GUO Division of Hematology & Oncology
- Wei-Wu Chen Division of Hematology & Oncology
- 張端瑩 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- HWEI-CHUNG WANG Division of General Surgery
- Chih-Jung Chen Division of General Surgery
- Ming-Yu Lien Division of Hematology & Oncology
- Liang-Chih Liu Division of General Surgery
- Ching-Chan Lin Division of Hematology & Oncology
- Yao-Chung Wu Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Tsu-Yi Chao Division of Hematology & Oncology
- Wei-Hong Cheng Division of Hematology & Oncology
- Yao-Yu Hsieh Division of Hematology & Oncology
- 蘇勇誠 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Principal Investigator
Co-Principal Investigator
- 夏和雄 Division of Hematology & Oncology
- Shih Hsin Tu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Breast Cancer
Objectives
Primary Objective:
• To investigate the PK (AUC) of orally administered paclitaxel (as Oraxol) in breast cancer patients
Secondary Objectives:
• To determine the safety and activity (response rate) of Oraxol in breast cancer patients
Test Drug
Oraxol
Active Ingredient
HM30181 methansulfonate monohydrate
Paclitaxel
Paclitaxel
Dosage Form
ORAL
ORAL
ORAL
Dosage
30
15
15
Endpoints
Primary Endpoint:
• Evaluation of PK parameters for oral paclitaxel
Secondary Endpoints:
• Safety
- Incidence of all AEs, including SAEs
- Laboratory values
- Other safety assessments including vital signs, physical exams, electrocardiograms (ECGs)
• Activity
- Tumor response rate, which is defined as the number of subjects with complete response (CR) or partial response (PR) at any post-baseline assessments expressed as the proportion of the total number of subjects in the Full Analysis Set
• Evaluation of PK parameters for oral paclitaxel
Secondary Endpoints:
• Safety
- Incidence of all AEs, including SAEs
- Laboratory values
- Other safety assessments including vital signs, physical exams, electrocardiograms (ECGs)
• Activity
- Tumor response rate, which is defined as the number of subjects with complete response (CR) or partial response (PR) at any post-baseline assessments expressed as the proportion of the total number of subjects in the Full Analysis Set
Inclution Criteria
Inclusion Criteria
Subjects must meet all of the following criteria to be included in this study:
1. Signed written informed consent
2. Women ≥18 years of age on day of consent
3. Breast cancer in patients for whom treatment with IV paclitaxel at 80 mg/m2 as monotherapy has been recommended by their oncologist
4. Measurable disease as per RECIST v1.1 criteria
5. Adequate hematological status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain:
• Absolute neutrophil count (ANC) ≥1.5 x 109/L
• Platelet count ≥100 x 109/L
• Hemoglobin (Hgb) ≥10 g/dL
6. Adequate liver function as demonstrated by:
• Total bilirubin of ≤1.5 mg/dL or ≤2.0 mg/dL for subjects with liver metastasis
• 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
7. Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
9. Life expectancy of at least 3 months
10. Willing to fast for 8 hours before and 4 hours after Oraxol administration on all treatment days
11. 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
12. Willing to refrain from caffeine consumption for 12 hours before each inpatient dosing period (Weeks 1 and 4) through the completion of protocol-specified PK sampling for that week
13. 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.
14. Subjects who are of childbearing potential must have a negative serum pregnancy test at Screening and within 72 hours before dosing.
Subjects must meet all of the following criteria to be included in this study:
1. Signed written informed consent
2. Women ≥18 years of age on day of consent
3. Breast cancer in patients for whom treatment with IV paclitaxel at 80 mg/m2 as monotherapy has been recommended by their oncologist
4. Measurable disease as per RECIST v1.1 criteria
5. Adequate hematological status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain:
• Absolute neutrophil count (ANC) ≥1.5 x 109/L
• Platelet count ≥100 x 109/L
• Hemoglobin (Hgb) ≥10 g/dL
6. Adequate liver function as demonstrated by:
• Total bilirubin of ≤1.5 mg/dL or ≤2.0 mg/dL for subjects with liver metastasis
• 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
7. Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
9. Life expectancy of at least 3 months
10. Willing to fast for 8 hours before and 4 hours after Oraxol administration on all treatment days
11. 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
12. Willing to refrain from caffeine consumption for 12 hours before each inpatient dosing period (Weeks 1 and 4) through the completion of protocol-specified PK sampling for that week
13. 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.
14. Subjects who are of childbearing potential must have a negative serum pregnancy test at Screening and within 72 hours before dosing.
Exclusion Criteria
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from this study:
1. Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
2. 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
3. Subjects unable to swallow study medication in its intact form or have clinically significant malabsorption syndrome
4. Only site of metastatic disease is unmeasurable according to RECIST v1.1 criteria
5. Known CNS metastasis, including leptomeningeal involvement
6. Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
7. Are currently receiving other medications intended for the treatment of their malignancy
8. Women who are pregnant or breastfeeding
9. Taking any of the following prohibited medications:
• Strong inhibitors (eg, ketoconazole) or 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 inducers (eg, rifampin) of CYP2C8 (within 2 weeks prior to the start of dosing in the study)
• Known P-gp inhibitors or inducers. Subjects 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
10. 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.
11. 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
12. Known allergic reaction or intolerance to study medication components
13. Known allergic reaction or intolerance to contrast media
14. Subjects who, in the Investigator’s opinion, are not suitable for participation in this study
Subjects who meet any of the following criteria will be excluded from this study:
1. Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
2. 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
3. Subjects unable to swallow study medication in its intact form or have clinically significant malabsorption syndrome
4. Only site of metastatic disease is unmeasurable according to RECIST v1.1 criteria
5. Known CNS metastasis, including leptomeningeal involvement
6. Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
7. Are currently receiving other medications intended for the treatment of their malignancy
8. Women who are pregnant or breastfeeding
9. Taking any of the following prohibited medications:
• Strong inhibitors (eg, ketoconazole) or 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 inducers (eg, rifampin) of CYP2C8 (within 2 weeks prior to the start of dosing in the study)
• Known P-gp inhibitors or inducers. Subjects 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
10. 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.
11. 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
12. Known allergic reaction or intolerance to study medication components
13. Known allergic reaction or intolerance to contrast media
14. Subjects who, in the Investigator’s opinion, are not suitable for participation in this study
The Estimated Number of Participants
-
Taiwan
24 participants
-
Global
0 participants
