NCT00129558撤回1 期
A Phase I/II Study of PT-523 in Patients With Refractory Leukemia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 12
研究概览
简要总结
This Phase I/II, multi-centered, non-randomized, trial is designed to determine a safe dose of PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as therapy in subjects with refractory leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Relapsed/refractory leukemias including acute non-lymphocytic leukemia (AML), acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), and chronic myelogenous leukemia in blastic phase (CML-BP) for which no standard therapies are anticipated to result in a durable remission; or poor-risk myelodysplasia (MDS) patients to include refractory anemia with excess blasts (RAEB) or excess blasts in transformation (RAEBT) and chronic myelomonocytic leukemia (CMML) who are either relapsed/refractory or who refuse/are not eligible for frontline therapy.
- •Only patients with refractory ALL or CML in lymphoid blastic phase are eligible for phase II.
- •ECOG performance status 0 -
- •Adequate organ function and bone marrow reserve.
- •At least 4 weeks must have elapsed from the time of major surgery.
- •Use of appropriate contraceptive method.
- •Signed patient informed consent.
排除标准
- •Known human immunodeficiency virus (HIV).
- •Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure.
- •Patients receiving any other standard or investigational treatment for their leukemia other than corticosteriods, hydroxyurea, and 6-mercaptopurine.
- •Any medical condition which, in the opinion of the investigator, places the patient at an unacceptably high risk for toxicities.
研究者
研究点 (12)
Loading locations...
相似试验
撤回
1 期
A Study to Assess the Safety and Preliminary Efficacy of PT-523 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)Non-Small-Cell Lung CarcinomaNCT00112060Spectrum Pharmaceuticals, Inc
已完成
2 期
Exploratory Study to Assess the Efficacy and Safety of TC-5214 in the Treatment of Subjects With Palmar HyperhidrosisPalmar HyperhidrosisNCT03404570Atacama Therapeutics60
进行中（未招募）
1 期
Safety and Efficacy Evaluation of BRL-101 in Subjects With Transfusion-Dependent β-ThalassemiaBeta-ThalassemiaNCT05577312Bioray Laboratories39
已完成
2 期
A Study Evaluating the Effect of Inhaled PT007(AS MDI) Versus Placebo MDI and Ventolin Evohaler on Lung Function in Adult Participants With AsthmaAsthmaNCT06644924AstraZeneca118
撤回
2 期
A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous UrticariaChronic Spontaneous UrticariaNCT05129423Genentech, Inc.