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
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum Tolerant Dose (MTD) and Dose Limiting Toxicity (DLT)
研究概览
简要总结
Phase Ib clinical study of Decitabine and Paclitaxel combination therapy
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age ≥ 19 years as female
- •be unable to operate for therapy with HER2 negative breast adenocarcinoma and metastatic breast cancer, one or more chemotherapy
- •according to RECIST ver.1.1, one or more evaluable lesion
- •Eastern cooperative oncology group(ECOG) performance score is o or 1
- •lesion for core biopsy
- •Within 28days of planned first study treatment day, laboratory safety test is satisfied. ANC ≥1500cells/microliter, Platelet count ≥ 100,000 cells/microliter, Hemoglobin≥8.5g/dl, ALT and AST ≤ 2ULN, ALP≤2.5ULN, Serum total bilirubin≤1.25 ULN, PT-INR and aPTT≤1.5ULN, Creatinine≥50ml/min
- •menopause or informed that effective contraception must be used during the entire treatment period of this study and for 6 months after exiting from the study
- •Given signed and dated written informed consent form
排除标准
- •Symptomatic metastasis and Leptomeningeal metastasis
- •Injection of paclitaxel for metastatic breast cancer within 6 months
- •HER2, Positive Breast adenocarcinoma
- •cancertherapy for whole body within 3 weeks
- •radiotherapy for metastatic region within 4 weeks
- •major surgery, open biopsy and trauma within 4 weeks
- •less than 4 weeks post major surgery
- •treatment with consistently systemic corticosteroid or immunosuppressive drug
- •more than 2 grade for peripheral neuropathy
- •Congenital ling QT syndrome or QTc interval > 480 milisecond
- •occur myocardial infartion within 6 months
- •unstable angina pectoris
- •HIV(+) or AIDS
- •HBsAg(+) or HCV(+)
- •treatment bisphosphonate for hypercalcemia
- •except metastatic and locally advanced breast cancer, personal history with malignancy within 5 years
- •hypersensitivity reaction with paclitaxel or Cremophor EL formulation
- •Pregnant or breast feeding
- •be unable or unwilling to abide by the study protocol or to cooperate fully with the investigator or designee
研究组 & 干预措施
Decitabine
A standard 3+3 trial design will be used for Decitabine dose escalation cohorts.
The number of cohorts is three. The subjects will be administered Decitabine on every seven days in a 28day cycle and Decitabine is sequential administered with Paclitaxel.
Cohort 1: Decitabine 15mg/m2, Cohort 2: Decitabine 20mg/m2, Cohort 3: Decitabine 25mg/m2
干预措施: Decitabine (Drug)
Decitabine
A standard 3+3 trial design will be used for Decitabine dose escalation cohorts.
The number of cohorts is three. The subjects will be administered Decitabine on every seven days in a 28day cycle and Decitabine is sequential administered with Paclitaxel.
Cohort 1: Decitabine 15mg/m2, Cohort 2: Decitabine 20mg/m2, Cohort 3: Decitabine 25mg/m2
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Maximum Tolerant Dose (MTD) and Dose Limiting Toxicity (DLT)
时间窗: for about 4 weeks
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.
次要结局
未报告次要终点