Phase II Study of SB1518 for Patients With Myelodysplastic Syndrome (MDS)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of Participants With Overall Response
研究概览
简要总结
The goal of this clinical research study is to learn if SB1518 can help to control myelodysplastic syndrome. The safety of the drug will also be studied.
SB1518 is designed to block JAK2 and FLT3. SB1518 may have anti-tumor activity in certain leukemias, myelofibrosis, and lymphoma.
详细描述
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take SB1518 by mouth 1 time every day. You can take it with or without food, and it should be taken at the same time every day.
You will receive your monthly supply of SB1518 during your clinic visit. The capsules should not be opened or crushed. Do not touch the powder in the capsules. If you do, wash effected areas thoroughly with water.
Each study cycle is 28 days.
Study Visits:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with MDS by the IPSS classification including low, int-1, int-2, and high risk are eligible. Patients should have received at least one line of prior therapy including growth factors, lenalidomide, or hypomethylating agents.
- •Signed informed consent.
- •Age >/= 18 years old.
- •Patients must have the following non-hematologic values: Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) </= 2.5 x Upper Limit of Normal (ULN) if both are available or </= 5.0 x ULN if hepatic involvement is present as determined by the investigator; Serum bilirubin </=2 x ULN; Serum creatinine </= 2 x ULN or 24-hour creatinine clearance >/= 50 ml/min
- •Patients, if sexually active, must agree to use appropriate forms birth control.
排除标准
- •Uncontrolled intercurrent illness, including but not limited to ongoing active infection or psychiatric illness or social situations that the treating physician judges would limit compliance with study requirements. Patients receiving antibiotics for infections that are under control may be included in the study.
- •History of myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure within 6 months prior to study enrollment;
- •New York Heart Association Class III or IV congestive heart failure;
- •Ongoing cardiac dysrhythmias of Grade >/= 2, atrial fibrillation of any grade, QTc prolongation > 470 ms or other factors that increase the risk of QT prolongation (e.g., heart failure; hypokalemia, defined as serum potassium < 3.0 mEq/L; family history of long QT interval syndrome);
- •Required use of a concomitant medication known to prolong the QT interval significantly.
- •Known HIV seropositivity;
- •Known active hepatitis A, B, or C;
- •Women who are pregnant or lactating.
研究组 & 干预措施
SB1518
400 mg orally a day for 28 day cycle.
干预措施: SB1518 (Drug)
结局指标
主要结局
Number of Participants With Overall Response
时间窗: 28 days to one year
Overall response based on hematologic improvement defined by International Working Group (IWG) response criteria in myelodysplasia. Complete remission (CR): Bone marrow of 5% myeloblasts with normal maturation of all cell lines, noted persistent dysplasia; Partial Remission: CR criteria if abnormal before treatment except Bone marrow blasts decreased by 50% over pretreatment but still \> 5%; Marrow CR: Bone marrow 5% myeloblasts and decrease by 50% over pretreatment. Bone marrow aspirate pre-therapy (Day 0) and on Day 28 of first cycle then every 3 cycles. Responses must last at least 4 weeks.
次要结局
未报告次要终点