A Biologic Correlates Study for "A Phase 2 Single-Arm Study To Assess The Efficacy and Safety Of 48-Hour Continuous Intravenous Dosing Of ON 01910.Na Administered Once a Week for 3 Weeks of a 4-Week Cycle in Myelodysplastic Syndrome Patients With Trisomy 8 or Classified as Intermediate-2 or High Ris
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Hematologic responses
研究概览
简要总结
This study is under Molecular and Cellular Characterization of Myelodysplastic Syndromes (MDS) (eProtocol 15369). The purpose of this proposed study is to analyze existing samples taken from participants participating in a clinical trial evaluating the efficacy and safety of investigational agent ON 01910.Na (eProtocol 16214). This study will use existing blood and marrow samples to determine the rate and duration of objective hematologic and marrow responses, and duration of progression-free survival in ON01910.Na-treated MDS patients.
This study will use existing blood and marrow samples to determine the rate and duration of objective hematologic and marrow responses, and duration of progression-free survival in ON01910.Na-treated MDS patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 IPSS Intermediate or High risk MDS by bone marrow biopsy, marrow cytogenetics and blood counts, using FAB morphologic criteria
- •Eastern Cooperative Oncology (ECOG) performance status of 0-2
- •Adequate Liver Function, as evidenced by a serum bilirubin less or equal to 1.5 times the laboratory normal range (except for patients with a confirmed diagnosis of Gilberts Disease) or an ALT and AST 3 times the laboratory normal range
- •A serum creatinine concentration less or equal to 2mg/dl
- •Subjects must be equal or greater than 18 years of age at the time of obtaining informed consent
- •Written informed consent
排除标准
- •Prior history of leukemia or aplastic anemia
- •Prior history of bone marrow transplantation
- •Platelet count <100,000/mm^3
- •*Prior malignancy (other than in situ cervical cancer, controlled prostate cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for greater or equal to 3 years before randomization
- •Active or uncontrolled infections
- •Unstable angina, congestive heart failure [NYHA>classII], uncontrolled hypertension [diastolic >100mmHg], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction
- •Less than 4 weeks since receipt of any investigational product or device
- •Pregnant or breast feeding
- •Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
- •Previously enrolled in this study
- •Will not be available for follow-up assessments
- •Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
结局指标
主要结局
Hematologic responses
时间窗: 4 months
Marrow blast decrement
次要结局
未报告次要终点
研究者
Peter L Greenberg
Professor Emeritus
Stanford University