NCT01913951已完成1 期
A Phase I Study of Vosaroxin Plus Azacitidine for Patients With Myelodysplastic Syndrome
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- MTD of vosaroxin in combination with azacitidine
研究概览
简要总结
This phase I trial studies the side effects and the best dose of vosaroxin when given together with azacitidine in treating patients with myelodysplastic syndromes. Drugs used in chemotherapy, such as vosaroxin and azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
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
- •Diagnosis of myelodysplastic syndrome and one of the following:
- •Cytopenias requiring red blood cell and/or platelet transfusions or neutropenia (ANC <1 X109/L)
- •IPSS score of INT-1 or higher at screening
- •MDS with excess blasts in transformation as defined by FAB criteria (20-29% bone marrow blasts) or
- •Chronic myelomonocytic leukemia
- •Age ≥18 years old
- •Adequate renal and hepatic function defined as all of the following:
- •total bilirubin ≤ 2.0 mg/dl, except in cases of Gilbert's disease;
- •AST and ALT ≤2.5 institutional ULN;
- •serum creatinine within normal institutional limits or estimated creatinine clearance ≥60 mL/min/1.73 m2 by the Cockcroft-Gault equation
- •ECOG performance status ≤2
- •Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
- •Females must be surgically or biologically sterile or postmenopausal or if of childbearing potential, must agree to use an adequate method of contraception during the study until 30 days after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 30 days after the last treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- •Patients may have received up to 3 prior cycles of hypomethylator therapy (i.e. decitabine or azacitidine) prior to enrollment and may have received supportive care measures (growth factors, erythropoietin stimulating agents, transfusion, etc.
- •Either enrolled in HRPO# 201011766 ("Tissue Acquisition for Analysis of Genetic Progression Factors in Hematologic Diseases"), which facilitates collection of blood, bone marrow, and skin for correlative studies, or consents to collection of blood, bone marrow, and skin as part of this protocol.
排除标准
- •Prior treatment with four or more cycles of hypomethylator therapy.
- •Receiving concomitant chemotherapy, radiation therapy, or immunotherapy during the duration of treatment on protocol.
- •Known seropositivity for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible. Patients who are seropositive for HCV, but have a negative viral load are also eligible. Documentation that the patients have completed a course of therapy for HCV is required and will be obtained.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant and/or breastfeeding.
研究组 & 干预措施
Treatment (vosaroxin, azacitidine)
Experimental
Patients receive vosaroxin IV over 10 minutes on days 1 and 4 and azacitidine SC or IV over 15 minutes on days 1-7. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
干预措施: vosaroxin (Drug)
Treatment (vosaroxin, azacitidine)
Experimental
Patients receive vosaroxin IV over 10 minutes on days 1 and 4 and azacitidine SC or IV over 15 minutes on days 1-7. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
干预措施: Azacitidine (Drug)
结局指标
主要结局
MTD of vosaroxin in combination with azacitidine
时间窗: 28 days
Defined as the highest dose of vosaroxin that results in a DLT in =\< 1 of 6 patients graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 4.0
次要结局
- Incidence of adverse events(Up to 7 months)
- Progression-free survival (PFS)(up to 5 years)
- Disease-free survival (DFS)(up to 5 years)
- Biomarkers of response to vosaroxin and azacitidine therapy(Up to 5 years)
- Time to response(Up to 7 months)
- Overall survival (OS)(up to 5 years)
- Best response (including hematologic improvement)(At 3 cycles)
- Best overall response(Up to 7 months)
- Event-free survival(up to 5 years)
研究者
研究点 (1)
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