Phase I Clinical Trial to Assess the Safety and Pharmacokinetic Profile of CKD-581 in Patients With Lymphoma or Multiple Myeloma Failed to Standard Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
This study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-581 injection in patients with Lymphoma failed to standard therapy. The usefulness of the this regimen is evaluated by response rate, progression free survival.
详细描述
Recently, the role of transcriptional repression through epigenetic modulation in carcinogenesis has been clinically validated with several inhibitors of histone deacetylases and DNA methyltransferases. It has long been recognized that epigenetic alterations of tumor suppressor genes was one of the contributing factors in carcinogenesis. Inhibitors of histone deacetylase (HDAC) de-repress genes that subsequently result in growth inhibition, differentiation and apoptosis of cancer cells. CKD-581 is developed for HDAC inhibitors. Such as to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-581 injection in patients with Lymphoma failed to standard therapy.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years and older
- •Histologically or cytologically confirmed Lymphoma or Multiple myeloma that have failed to standard therapy or for which no life prolonging treatment exists
- •ECOG(Eastern cooperative oncology) performance status ≤ 2
- •Life expectancy 12 weeks
- •Hematopoietic: ANC(Absolute Neutrophil Count) ≥ 1,500/mm3, Platelet count(PLT) ≥ 100,000/mm3, Hemoglobin ≥ 9.0g/dL
- •Hepatic: Total bilirubin > 1.5×upper limit of normal(except Gilbert's syndrome patients), aspartate aminotransferase(AST) > 3×upper limit of normal, alanine aminotransferase(ALT) > 3×upper limit of normal(AST, ALT ≤ 5.0×ULN in case of liver metastases)
- •Renal: serum creatinine ≤ 1.5×upper limit of normal
- •Serum calcium ≤ upper limit of normal (If the Multiple myeloma only)
- •Signed a written informed consent
排除标准
- •Have symptoms with Brain metastases
- •History of Ischemic heart disease(e.g., myocardial infarction, unstable angina pectoris) or Clinically significant heart disease such as NYHA Class III and IV Congestive atrial arrhythmias, within 6 months prior to first dose of study drug
- •Acute infection or blooding tendencies that would preclude study compliance
- •Other psychiatric disorders or other conditions that would preclude study compliance
- •Receiving antitumor therapy(surgery, immunotherapy or chemotherapy) within 4 weeks prior to first dose of study drug(6 weeks for nitrosoureas and mitomycin C, 2 weeks for radiation therapy)
- •Other concurrent antitumor therapy
- •Have Cardiac disease by nature
- •Administration history of Histone Deacetylase Inhibitor
- •History of Serious hypersensitivity or allergy
- •Pregnant or nursing, active serum pregnancy test. Fertile patients must use effective contraception
- •Participation in a clinical trial within 4 weeks of first dose of study drug
研究组 & 干预措施
Treatment
CKD-581
干预措施: CKD-581 (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: Up to 28 days (For 1st cycle)
次要结局
- Progression Free survival(up to progression)
- Pharmacokinetics(0, 0.25, 1, 1.5, 2, 2.25, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hrs post dose(1st cycle Day1, 15))
- Objective response rate(every 56 days (every 2 cycle))
- Dose Limiting Toxicity(Up to 28 days (For 1st cycle))