NCT03051841Unknown1 期
A Phase I, Open-Label, Multi-Center Study of CKD-581 in Combination With Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose(MTD)
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 Combination with Bortezomib and Dexamethasone in patients with Previously Treated Multiple Myeloma.
详细描述
This is an open label, dose escalation study. Cohort of 3~6 patients receive escalation doses of CKD-581 until the maximum toleated dose(MTD) is determined. The MTD is defiend as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
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
- •must have received at least one prior lines of therapy and Diagnosis of symptomatic multiple myeloma(IMWG 2014)
- •Eastern Cooperative Oncology Group performance status ≤ 2
- •Life expectancy 12 weeks
- •must have the following laboratory values within 3 weeks prior to first dose of study drug
- •ANC(absolute neutrophil count) ≥ 1,500 mm3
- •PLT(platelet count)≥ 100,000 mm3
- •Hb ≥ 8.0g/dL
- •AST(SGOT) and ALT (SGPT) ≤ 3 x UNL(upper limit of normal)
- •Serum bilirubin ≤ 1.5 x ULN (but, Gilbert syndrome ≤ 3 x UNL)
- •Serum Cr ≤ 1.5 x UNL
- •One more measureable disease following values
- •Serum M-protein ≥ 1g/dL
- •Urine M-Protein ≥ 200mg/24hr
- •in that case serum M-protein, urine M-Protein nonmeasurable and FLC ratio abnormal, Serum FLC level ≥ 100mg/L(≥10mg/dL)
- •more than 24 weeks prior to last bortezomib dose
- •must have signed the consent form
排除标准
- •Patients with central neurological disease
- •Patients with clinically significant heart disease within 24weeks prior to first dose of study drug
- •patients with clinically significans abnormal EKG, echocardiography at screening
- •patients with active hepatitis, HIV positive(exception, non active hepatitis)
- •peripheral neuropathy ≥ CTCAE grade 2 or peripheral neuropathy ≥ CTCAE grade 1 with pain within 2 weeks prior to first dose of study drug
- •Patients with a prior malignancy with in the last 3 years except adequately treated basal cell or squamous cell or skin cancer, in situ cervical cancer
- •Patients who have received surgery, chemotherapy, radiation therapy or immunotherapy or any other investigational drugs ≤ 4 weeks prior to first dose of study drug and during treatment period
- •Women who are pregnant or breast feeding or women of childbearing potential not using an effective method of birth control. Male patients whose sexual partners are not using effective birth control.
- •patients with hypersensitive reaction of bortezomib or dexamethasone
- •patients without best overall response is above minimal response based on IMWG 2015 past all treatment for multiple myeloma
- •patients with refractory to past bortezomib treatment(ex; under minimal response) or progress within 60days prior to last bortezomib treatment
研究组 & 干预措施
Treat Regimen
Experimental
CKD-581(investigational Drug) Bortezomib Dexamethasone
干预措施: CKD-581 (Drug)
结局指标
主要结局
Maximum Tolerated Dose(MTD)
时间窗: Up to 21 days(for 1st cycle)
次要结局
- Pharmacokinetics( MRT)(1st Cycle day1, Day8: up to 24hr)
- Pharmacokinetics(Cmax)(1st Cycle day1, Day8: up to 24hr)
- Number of participants with toxicity as assessed by CTCAE v4.03 through study completion, an average of 1 year(through study completion, an average of 1 year)
- Duration of Response(DOR) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks(Average time period between the day of first achievement of response and the day of first relapse or progression, up to 1year)
- Pharmacokinetics(CL)(1st Cycle day1, Day8: up to 24hr)
- Pharmacokinetics(AUClast)(1st Cycle day1, Day8: up to 24hr)
- Overall Survival(OS) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks(Average time period between the start day of induction therapy and the day of death, due to any cause, up to 1year)
- Objective Response Rate(ORR) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks(every 6weeks, up to 1year)
- Progression Free Survival(PFS) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks(Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly, up to 1year)
- Pharmacokinetics(T1/2)(1st Cycle day1, Day8: up to 24hr)
- Pharmacokinetics(AUCinf)(1st Cycle day1, Day8: up to 24hr)
- Pharmacokinetics(Vd)(1st Cycle day1, Day8: up to 24hr)
研究者
研究点 (1)
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