Trial to Determine the Maximum Tolerated Dose of Genexol-PM Plus Gemcitabine and Evaluate Efficacy and Safety of Genexol-PM Regimens in Subjects With Advanced Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 主要终点
- The maximum tolerated dose (MTD) of the combination therapy with Genexol-PM and gemcitabine
研究概览
简要总结
This is a phase I/II trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine (hereafter Genexol-PM plus gemcitabine) and to evaluate the efficacy and safety of Genexol-PM regimens (monotherapy and combination with gemcitabine) and gemcitabine monotherapy in subjects with locally advanced or metastatic pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who aged 18 years or older
- •Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial
- •Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required.
- •Subjects with no other malignancy diagnosed within past five years except for:
- •Cured non-melanoma skin cancer
- •Cured cervical intraepithelial neoplasia (CIN)
- •Cured In-situ cervical cancer (CIS)
- •Subjects who are ECOG performance status of ≤ 1
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Genexol-PM 220 mg/m2 + Gemcitabine 1,250 mg/m2
干预措施: Genexol-PM (Drug)
Cohort 2
Genexol-PM 260 mg/m2 + Gemcitabine 1,250 mg/m2
干预措施: Genexol-PM (Drug)
Cohort 3
Genexol-PM 300 mg/m2 + Gemcitabine 1,250 mg/m2
干预措施: Genexol-PM (Drug)
结局指标
主要结局
The maximum tolerated dose (MTD) of the combination therapy with Genexol-PM and gemcitabine
时间窗: 1 year
The recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine
时间窗: 1 year
次要结局
- Time to tumor progression(1 year)
- Safety profiles(1 year)
- Progression free survival(1 year)
- Objective response rate (complete response (CR) + partial response (PR))(1 year)