Phase Ib clinical study of Decitabine and Paclitaxel combination therapy
An open-labelled, parallel, multiple ascending dose, phase Ib clinical study of Decitabine and Paclitaxel combination therapy in treating patients with metastatic and locally advanced breast cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
The subjects will be sequential administered with Decitabine and paclitaxel 80mg/m2 by IV(intravenous) infusion. Decitabine is starting dose of 15mg/m2 on 1D, 8D, 22D, 28D of a 28day cycle. Paclitaxel 80mg/m2 will be dosed in combination therapy with Decitabine on 8D, 22D, 28D of a 28day cycle.
The subjects will be sequential administered with Decitabine and paclitaxel 80mg/m2 by IV(intravenous) infusion. Decitabine is starting dose of 15mg/m2 on 1D, 8D, 22D, 28D of a 28day cycle. Paclitaxel 80mg/m2 will be dosed in combination therapy with Decitabine on 8D, 22D, 28D of a 28day cycle.
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Maximum Tolerant Dose (MTD) and Dose Limiting Toxicity (DLT)
According to principle of Dose Limited Toxicity (DLT) assessment by National Cancer Institute Common Terminonlgy Criteria for Adverse Events (NCI-CTCAE, V4.0), DLT is evaluated above grade 3 as adverse event.
Time frame: for about 4 weeks
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