NCT02140606Unknown1 期
An Open Phase I Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Intravenous Cafusertib Hydrochloride in Combination With Subcutaneous Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)
Jiangsu Hansoh Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 试验地点
- 1
- 主要终点
- MTD of cafusertib in combination with LDAraC based on the incidence of dose limiting toxicities
研究概览
简要总结
To investigate safety, tolerability of cafusertib combination with low dose cytarabine (LD-Ara-C) in Chinese patients with relapsed/refractory AML that are not eligible for conventional or intensive treatment. The dose of cafusertib will be escalated to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of cafusertib in combination with LD-Ara-C in AML patients. At the same time, pharmacokinetic characteristics and preliminary efficacy of cafusertib will be observed in AML patients. To determine the recommended dosage regimen for phase II.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Signed written informed consent consistent with Chinese Good Clinical Practice.
- •Male or female patients of age >/= 18 years at the time of informed consent.
- •Patients with relapsed/refractory AML ineligible for conventional or intensive treatment.
- •Eastern Cooperative Oncology Group performance status score 0 - 2 at screening.
- •Life expectancy of at least 3 months.
- •Adequate hepatic, renal and metabolic function parameters: Serum total bilirubin ≤1.5 x upper limit of normal, aspartate transaminase (AST) , alanine transaminase (ALT) ≤2.5 x upper limit of normal; Creatinine clearance rate ≥60ml/min, Serum creatinine ≤1.0 x upper limit of normal; Relatively normal ECG(electrocardiogram), QTc<450 ms(male) ,QTc<470 ms(female); LVEF>50%.
- •Patients who can comply with the trial and follow-up procedures.
排除标准
- •Patients had received cafusertib hydrochloride or other PLK inhibitors.
- •Patients with APL.
- •Patients with central nervous system leukemia.
- •Need to continue using cytokine therapy at screening.
- •Patients participated in other clinical trials within 4 weeks prior to enrollment.
- •Patient with severe infection.
- •Patients with myocardial infarction had occurred within six months prior to enrollment.
- •Severe heart disease, including NYHA class II cardiac dysfunction and above.
- •Patients with HIV infection or acute and chronic viral hepatitis.
- •Severe gastrointestinal disorders (bleeding, infection, obstruction or greater than grade 1 diarrhea).
- •A previous history of neurological or psychiatric disorders, including epilepsy or dementia.
- •Concomitant medications with CYP3A4 inhibitors, inducers or substrates; Women pregnant or breast feeding.
- •Subject is thought unfit for this study by investigator.
研究组 & 干预措施
Cafusertib Hydrochloride + Cytarabine
Experimental
Cafusertib (d1 and 15 - one hour iv.) + LD ARA C 2x20 mg/d s.c. Patient to receive escalating dose of cafusertib hydrochloride.
干预措施: Cafusertib Hydrochloride (Drug)
结局指标
主要结局
MTD of cafusertib in combination with LDAraC based on the incidence of dose limiting toxicities
时间窗: 4 weeks
次要结局
- Incidence and intensity of adverse events graded according to CTCAE (version 4.0)(minimum 4 weeks, maximum n.a.)
- Incidence of dose limiting toxicity (DLT)(4 weeks)
- Pharmacokinetics of cafusertib(4 weeks)
- Efficacy (complete remission, CR; complete remission with incomplete blood count recovery, Cri; Partial remission (PR))(minimum 4 weeks, maximum n.a.)
研究者
研究点 (1)
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