NCT00485966撤回2 期
A Phase 2, Multi-Center, Open Label Study Evaluating Clinical Efficacy, Safety, and Pharmacodynamic Effects of Quarfloxacin (CX-3543) in Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)
Cylene Pharmaceuticals14 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2007年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 25
- 试验地点
- 14
- 主要终点
- Efficacy
研究概览
简要总结
This is a Phase 2, open-label, multicenter, efficacy, safety, and pharmacodynamic study of CX-3543 in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL).
详细描述
The purpose of this trial is to evaluate the response rate, safety, pharmacodynamic effects, and duration of response of CX-3543 in patients with relapsed or refractory B-cell CLL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 B-cell CLL with indications for treatment by National Cancer Institute (NCI) Working Group criteria.
- •Measurable disease (lymphocytes ≥ 5,000/microliter, or palpable lymphadenopathy or bone marrow involvement > 30%).
- •Males and females 18 years of age or older.
- •Received a minimum of one prior purine analog-based chemotherapy regimen (e.g., fludarabine, cladribine, or pentostatin) and one monoclonal antibody therapy (e.g., Campath or Rituxan) but ≤ 4 chemotherapy regimens.
- •Patients must have central intravenous (IV) access, or agree to the insertion of a central line.
- •All previous cancer therapies, radiation, hormonal therapy and surgery, must have been discontinued at least 28 days prior to the start of treatment. Any cytotoxic chemotherapy must have been discontinued 28 days prior to the start of treatment. Acute toxicities from prior therapy must have resolved to Grade ≤ 1 above baseline.
- •Normal oxygen saturation with pulse oximetry on room air.
- •Hemoglobin ≥ 9 gm/dL (may be post-transfusion).
- •Platelet count ≥ 25,000/microliter.
- •Total bilirubin < 2 X upper limit of normal (ULN), and ALT and AST < 2 x ULN.
- •Serum creatinine within normal limits OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above the upper normal limit for the institution
- •ECOG Performance Status ≤
- •Anticipated survival of at least 3 months.
- •For men and women of child-producing potential, use of effective contraceptive methods during the study and for one month after discontinuation of treatment.
- •Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return to the clinic for required assessments.
排除标准
- •Pregnant or nursing women.
- •Severe chronic obstructive pulmonary disease with hypoxemia or an uncorrectable pulmonary compromise.
- •Seizures not controlled by anticonvulsant therapy.
- •Participation in any investigational drug study within 28 days before quarfloxacin administration.
- •Patients with second malignancy requiring active treatment.
- •Active symptomatic bacterial, fungal, or viral infection including active HIV or viral (A, B, or C) hepatitis.
- •Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis.
- •Patients who have exhibited allergic reactions to a similar structural compound (e.g., fluoroquinolones) or formulation (containing buffers and/or polyethylene glycol).
- •Patients with life- or function-threatening CLL complications (e.g., cord compression, hemolytic crisis, urinary tract obstruction).
- •Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any of the study's endpoints.
结局指标
主要结局
Efficacy
Safety
次要结局
- Clinical benefit
- Pharmacodynamics
- Study drug blood levels
- Progression free survival
研究者
研究点 (14)
Loading locations...
相似试验
已完成
3 期
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508delCystic FibrosisNCT02797132Vertex Pharmaceuticals Incorporated62
已完成
2 期
A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric SubjectsChronic Hepatitis C InfectionNCT02486406AbbVie64
已完成
2 期
The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseNCT03487913Palladio Biosciences31
进行中（未招募）
2 期
A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)Duchenne Muscular DystrophyNCT06450639Hoffmann-La Roche30
已完成
3 期
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants With InhibitorsHemophilia ANCT02622321Hoffmann-La Roche113