NCT01463982已完成1 期
A Phase I Clinical Trial to Determine the Maximum Tolerated Dose and to Assess the Safety of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Cancer
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination
研究概览
简要总结
The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan in combination with capecitabine
详细描述
Besides the main objective, there are 4 other objectives as follows:
- To assess the safety of Oratecan in combination with capecitabine
- To evaluate anticancer activity of Oratecan in combination with capecitabine in patients with advanced solid malignancies
- To characterize the pharmacokinetics of Oratecan and its metabolites following oral administration of OratecanTM in combination with capecitabine
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed advanced solid tumor
- •Patients who have experienced progressive disease despite of conventional anticancer therapy. Patients who cannot expect effective treatment or prolonged survival with conventional anticancer therapy
- •Previous chemotherapy, radiotherapy and surgical operation are allowed if they are discontinued for at least 4 weeks prior to D0 and all adverse events are resolved
- •Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
- •A life expectancy greater than 12 weeks
- •Adequate bone marrow, renal and liver function.
- •Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures
排除标准
- •Patients with hematopoietic malignancies,uncontrolled infection, CNS metastasis.
- •Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT
- •Patients who have GI malabsorption or difficulty taking oral medication
- •Patients who have psychiatric or congenital disorder Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments
- •Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.)
研究组 & 干预措施
Oratecan and Capecitabine
Experimental
Oratecan(HM30181AK + Irinotecan HCl) and Capecitabine
- Irinotecan HCl Tablet - Initial dose 10 mg/m2 (may be increased up to 20 mg/m2), Day1~Day5
- HM30181AK Tablet - Fixed dose 15 mg, Day1~Day5
- Capecitabine Tablet - Initial dose 800 mg/m2 (may be increased up to 1000 mg/m2), Day1~Day14
干预措施: Oratecan and Capecitabine (Drug)
结局指标
主要结局
Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination
时间窗: Cycle 1 (21 days)
If Dose Limiting Toxicity(DLT) was not observed in the third subject at a dose level from the first study drug dosing date (Day 1) to the end of Cycle 1(21 days), increase the dose to the next level and enroll subjects; enrollment up to Level 4 was allowed. (NCI-CTCAE version 3.0)
次要结局
- Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR)(tumor response evaluation can continue to receive the study drug until PD confirmation)
研究者
研究点 (1)
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