NCT03906695进行中（未招募）1 期
A Multicenter, Open-label, Dose-escalation, Phase 1 Trial to Investigate the Tolerability and Safety of ASTX727 in Subjects With Lower-risk Myelodysplastic Syndromes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity
研究概览
简要总结
To investigate the tolerability and safety of ASTX727 in Japanese subjects with lower-risk MDS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Subjects with a definitive diagnosis of MDS and classified as low or Intermediate-1 risk by the International Prognostic Scoring System (IPSS) risk category
- •Subjects meeting at least one of the disease-related criteria for Red blood cell (RBC) transfusion, hemoglobin (Hb) ,Absolute neutrophil count,Platelet count within 8 weeks prior to initial administration of IMP
- •Subjects with Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- •Adequate hepatic and renal function
- •Sexually active men with reproductive capacity (except those who have undergone bilateral orchidectomy) must agree to use 2 effective contraceptive measures or remain abstinent during the trial and for 3 months after final administration of IMP. Sexually active women of child-bearing potential must agree to use 2 effective contraceptive measures or remain abstinent during the trial and for 6 months after final administration of IMP.
- •Subjects who have provided written informed consent using the form approved by the institutional review board
排除标准
- •Subjects who have received cytokine therapy, immunosuppressant therapy, or chemotherapy within 4 weeks prior to initial investigational medicinal product (IMP) administration
- •Subjects who have received any other IMP or privately-imported medicine within 2 weeks prior to initial IMP administration
- •Subjects with deletion 5q who are to be treated with lenalidomide
- •Subjects with current or previous bone marrow blast percentage of >10%
- •Subjects with a diagnosis of chronic myelomonocytic leukemia
- •Subjects with heart disease of New York Heart Association (NYHA) Functional Class 3 or 4
- •Subjects with an uncontrolled systemic disease or active uncontrolled infection
- •Subjects with diabetes mellitus requiring medical treatment
- •Subjects with a life-threatening illness, medical condition or multiple organ dysfunction, or other reason, including laboratory abnormalities, which in the investigator's or subinvestigator's opinion could compromise the subject's safety, interfere with the absorption or metabolism of IMP, or compromise the integrity of the trial outcome
- •Subjects with prior malignancy
- •Subjects who test positive for human immunodeficiency virus antibody, hepatitis B virus DNA, or hepatitis C virus antibody
- •Subjects with a history of surgical gastrectomy
- •Subjects with previous organ transplantation
- •Subjects with a ≥Grade 2 AE attributable to treatment of underlying disease, excluding the AEs
- •Subjects who have undergone an invasive and extensive operation within 2 weeks prior to initial IMP administration
- •Subjects with hypersensitivity to the IMPs or their excipients
- •Subjects with known significant mental illness or other condition, such as active alcohol or other substance abuse or addiction, that in the opinion of the investigator or subinvestigator predisposes the subject to high risk of noncompliance with the protocol
- •Female subjects who are pregnant, breast-feeding, or who test positive for pregnancy at screening
研究组 & 干预措施
10-Day Schedule
Experimental
10-Day Schedule
Investigational Medicinal Products (IMP) will be administered for 10 days in total per 4 weeks, i.e. a 28-day cycle.
干预措施: ASTX727 (Drug)
5-Day Schedule A
Experimental
5-Day Schedule A
IMP will be administered for 5 days in total per 4 weeks, i.e. a 28-day cycle.
干预措施: ASTX727 (Drug)
5-Day Schedule B
Experimental
5-Day Schedule B
IMP will be administered for 5 days in total per 4 weeks, i.e. a 28-day cycle.
干预措施: ASTX727 (Drug)
5-Day Schedule C
Experimental
5-Day Schedule C
IMP will be administered for 5 days in total per 4 weeks, i.e. a 28-day cycle.
干预措施: ASTX727 (Drug)
7-Day Schedule
Experimental
7-Day Schedule
IMP will be administered for 7 days in total per 4 weeks, i.e. a 28-day cycle.
干预措施: ASTX727 (Drug)
结局指标
主要结局
Dose Limiting Toxicity
时间窗: 28days
次要结局
- Area under the curve (AUC)(Pre-dose, 15 min, 30 min, 60 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h after dosing)
- Maximum plasma concentration (Cmax)(Pre-dose, 15 min, 30 min, 60 min, 90 min, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h after dosing)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDSMyelodysplastic SyndromesNCT03502668Taiho Oncology, Inc.160
已完成
2 期
An add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)Refractory Partial SeizuresNCT00849212Eisai Co., Ltd.30
已完成
1 期
A Phase I Study of LJM716 in Japanese Patients With Advanced Solid TumorsNeoplasmsNCT01911936Novartis Pharmaceuticals12
已完成
1 期
Study to Assess Safety and Tolerability of AZD4547 in Japanese PatientAdvanced Solid MalignanciesCancerNCT01213160AstraZeneca40
已完成
2 期
A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.Systemic Lupus ErythematosusNCT01031836AstraZeneca30