NCT04402723终止1 期
A Dose-escalated Phase Ⅰ Trial to Assess the Tolerance and Pharmacokinetics of Combination of Donafenib and Cytarabine/Daunorubicin in Relapsed AML Patient
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Safety(including the type, severity and frequency of AE)
研究概览
简要总结
This phase Ⅰ study of Donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess safety and pharmacokinetics in patients with Relapsed AML.
详细描述
Donafenib is a multikinase inhibitor which is acting on various cellular pathways involved in the genesis of acute myeloid leukemia (AML). Donafenib is therefore a promising candidate for improvement of chemotherapy results in AML. This clinical trial evaluates the safety and pharmacokinetics of Donafenib combination with Cytarabine/Daunorubicin for AML in patients between 18 and 55 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosed AML (except APL) according to the FAB and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML) .
- •Patients with diagnosed Relapsed AML according to Chinese Guidelines for the Diagnosis and Treatment of Acute Myeloid Leukemia.
- •relapse after 6 months of an morphological remission.
- •Age ≥ 18 and ≤ 55 years.
- •BMI ≥ 18 and ≤
- •Informed consent, personally signed and dated to participate in the study.
- •ECOG performance status of 0-
- •Life expectancy of at least 12 weeks.
- •Total serum bilirubin ≤1.5×ULN.
- •Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 2.5×ULN.
- •Serum creatinine ≤1.5×ULN.
- •glomerular filtration rate ≥60 mL/min, as calculated with the Cockcroft-Gault formula.
- •alkaline phosphatase ≤1.5×ULN.
- •urine protein ≤1+, or Urine protein was quantified for 24h ≤0.5g.
- •INR/PTT <1.5×ULN.
排除标准
- •Patients who are not eligible for standard chemotherapy as per discretion of the treating physician.
- •Patients who have been treated with bone marrow transplantation.
- •Central nervous system manifestation of AML.
- •Cardiac disease: heart failure NYHA III or IV; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
- •Patients who have thrombosis events within 6 months prior to study entry is permitted.
- •Pregnancy or breastfeed.
- •Chronic pulmonary disease with relevant hypoxia.
- •Patients undergoing dialysis.
- •Known HIV and/or hepatitis C infection.
- •Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy.
- •Evidence or recent history of CNS disease, including primary or metastatic brain tumors, seizure disorders.
- •Blood pressure (BP) higher than systolic 140 mmHg and/or diastolic 90 mmHg after best treatment.
- •Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance of the protocol.
- •Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks prior to study entry is permitted.
- •Serious, non-healing wound, ulcer or bone fracture.
- •Infection need antibiotic treatment.
- •Cumulative therapeutic dose of Daunorubicin more than 300mg/m
- •Concurrent malignancies other than AML.
- •History of organ allograft.
- •Allergy to study medication or excipients in study medication.
研究组 & 干预措施
Donafenib, 0.2g
Experimental
Donafenib,0.2g,bid,Combination with Cytarabine and Daunorubicin.
干预措施: Donafenib (Drug)
Donafenib,0.3g
Experimental
Donafenib,0.3g,bid,Combination with Cytarabine and Daunorubicin
干预措施: Donafenib (Drug)
结局指标
主要结局
Safety(including the type, severity and frequency of AE)
时间窗: through study completion, an average of 2 months
Safety of combination of donafenib with Cytarabine/Daunorubicin in relapsed AML patients.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Sorafenib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Chronic Myelogenous LeukemiaAdult Acute Basophilic LeukemiaAdult Acute Eosinophilic LeukemiaAdult Acute Megakaryoblastic Leukemia (M7)Adult Acute Minimally Differentiated Myeloid Leukemia (M0)Adult Acute Monocytic Leukemia (M5b)Adult Acute Myeloblastic Leukemia With Maturation (M2)Adult Acute Myeloblastic Leukemia Without Maturation (M1)Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Adult Acute Myelomonocytic Leukemia (M4)Adult Erythroleukemia (M6a)Adult Pure Erythroid Leukemia (M6b)Recurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaNCT00131989National Cancer Institute (NCI)48
进行中（未招募）
1 期
Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular CarcinomaUnresectable Hepatocellular CarcinomaNCT04605185Suzhou Zelgen Biopharmaceuticals Co.,Ltd18
终止
1 期
A Study of Donafenib Monotherapy in Advanced Oesophageal CancerOesophageal CancerNCT02489201Suzhou Zelgen Biopharmaceuticals Co.,Ltd19
已完成
1 期
Study of XL281 in Adults With Solid TumorsNon-small-cell Lung CancerPapillary Thyroid CancerCancerColorectal CancerMelanomaNCT00451880Exelixis180
暂停
1 期
Regorafenib in Combination With Venetoclax and Azacitidine for the Treatment of Patients With Relapsed or Refractory Acute Myeloid LeukemiaMyelodysplastic Syndrome/Acute Myeloid LeukemiaRecurrent Acute Myeloid LeukemiaRecurrent Myelodysplastic SyndromeRefractory Acute Myeloid LeukemiaRefractory Myelodysplastic SyndromeNCT06454409City of Hope Medical Center20