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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Oraxol (oral paclitaxel + oral HM30181AK-US) Paclitaxel: supplied as capsules HM30181 methanesulfonate monohydrate: supplied as HM30181AK-US tablets
Taipei Medical University Shuang Ho Hospital
New Taipei City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Tr-Service General Hospital
Taipei, Taiwan
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.
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)
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.
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.
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Taipei Veterans Generla Hospital
Taipei, Taiwan, 11217, Taiwan