Clinical Trials List
2017-09-01 - 2021-12-31
Phase I
Terminated6
ICD-10C50
Malignant neoplasm of breast
ICD-10C79.81
Secondary malignant neoplasm of breast
An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007
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Trial Applicant
-
Sponsor
PharmaEssentia
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Ling-Ming Tseng Division of Radiation Therapy
- Chun-Yu Liu Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
3 Terminated
Audit
None
Co-Principal Investigator
- Liang-Chih Liu Division of Hematology & Oncology
- Ming-Yu Lien Division of Hematology & Oncology
- Chih-Jung Chen Division of Hematology & Oncology
- Yao-Chung Wu Division of Hematology & Oncology
- HWEI-CHUNG WANG Division of Hematology & Oncology
- Ching-Chan Lin Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Wei-Hong Cheng Division of Hematology & Oncology
- Yao-Yu Hsieh Division of Hematology & Oncology
- Tsu-Yi Chao Division of Hematology & Oncology
- 蘇勇誠 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
5 Terminated
Audit
None
Co-Principal Investigator
- Wei-Wu Chen Division of Hematology & Oncology
- 林季宏 Division of Hematology & Oncology
- JHE-CYUAN GUO Division of Hematology & Oncology
- 張端瑩 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Paclitaxel
Dosage Form
tablet
Dosage
Endpoints
Safety：
- Incidence of all adverse events (AEs), including serious adverse events
(SAEs)
- Laboratory values
- Other safety assessments including vital signs, physical exams,
electrocardiograms (ECGs)
2. Secondary endpoints:
Activity:
- Tumor response, which is the number of patients with CR or PR at any
post-baseline assessments after the start of treatment in KX-ORAX-007
- Duration of time on treatment since the start of treatment in
KX-ORAX-007
Inclution Criteria
Patients must meet all of the following criteria to be included in this study:
(1) Breast cancer patients who have completed Study KX-ORAX-007 without
disease progression at Week 16, who wish to continue Oraxol treatment
(2) Signed written informed consent
(3) Willing to fast for 6 hours before and 2 hours after Oraxol administration
on all treatment days
(4) 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.
Exclusion Criteria
(2) Are currently receiving other medications intended for the treatment of their malignancy
(3) Women who are pregnant or breastfeeding
(4) Taking any of the following prohibited medications:
- 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 or inducers. Patients 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
(5) 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.
(6) 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
(7) Known allergic reaction or intolerance to study medication components
(8) Known allergic reaction or intolerance to contrast media
(9) Patients 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
