NCT01455571已完成1 期
Phase I Study to Determine the Maximum Tolerated Dose and to Assess the Safety and Pharmacokinetic Profile of HM781-36B
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2009年11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
- 55
- 试验地点
- 1
- 主要终点
- MTD determination
研究概览
简要总结
The main objective of this study is to determine the maximum tolerated dose (MTD) of HM781-36B.
详细描述
Besides the main objective, there are 3 other objectives as follows:
- To determine dose-limiting toxicity (DLT) of HM781-36B
- To characterize the pharmacokinetics of HM781-36B, following oral administration of HM781-36B
- To evaluate anticancer activity of HM781-36B in patients with advanced solid malignancies Groups of 3 patients per cohort or dose level will be treated with escalating doses of HM781-36B
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 2) Patients who have experienced progressive disease despite of conventional anticancer therapy. Patients who cannot expect effective treatment or prolonged survival with conventional anticancer therapy 3) 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 4) Aged ≥19 5) Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2 6) A life expectancy greater than 12 weeks 7) Adequate bone marrow (WBC≥4,000/mm3 platelet≥100000/mm3, hemoglobin≥9.0g/dl and ANC≥ 1500/mm3, renal (Creatinine≤1.5mg/dl) and liver function (AST/ALT/ALP ≤ 3 x upper limit of normal and total bilirubin≤2mg/dl) and no abnormal heart and lung function However, AST/ALT/ALP ≤ 5 x upper limit of normal for patients with liver metastases and ALP level ≤ 5 x upper limit of normal for patients with bone metastases are allowed 8)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, ileus, CNS metastasis.
- •Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT 3) Class III or IV heart failure (NYHA Class) or LVEF<40% 4) Patients who have GI malabsorption or difficulty taking oral medication 5) Patients who have psychiatric or congenital disorder 6) Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments 7) Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.) 8) Subjects who have no intention of following the requirements of the protocol or the follow-up management. Subjects who cannot be followed up regularly due to psychological, social, family, logistic, and geographical reasons 9) Subjects who were administered with other investigational products within 30 days before screening.
- •Subjects who, in the investigator's opinion, cannot be participated.
研究组 & 干预措施
HM781-36B
Experimental
Dose : 0.5mg, 1mg, 2mg, 4mg, 8mg, 12mg, 16mg, 20mg,...
干预措施: HM781-36B (Drug)
结局指标
主要结局
MTD determination
时间窗: Dose limiting Toxicity will be evaluated on Day 21 during Cycle 1
次要结局
未报告次要终点
研究者
研究点 (1)
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