NCT00344786终止1 期
A Phase 1, Dose-Escalation Study of CNF2024 Administered Orally to Patients With B Cell Chronic Lymphocytic Leukemia (CLL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Safety and toxicity (maximum tolerated dose (MTD))
研究概览
简要总结
CLL dosing escalating study; daily dosing schedule; PK/PD safety
详细描述
Phase 1, open-label, accelerated-titration study designed to evaluate the effects of increasing doses of CNF2024 on safety, pharmacokinetics, pharmacodynamic markers, and hematological response
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 CLL who relapsed following or are intolerant to purine analog -based therapy
- •Hemoglobin >=9 gm/dL (may be post-transfusion)
- •Total bilirubin <2 X ULN, and ALT and AST <2 x ULN
- •Creatinine <=2 X ULN
- •Normal plasma cortisol and ACTH concentrations
- •ECOG Performance Status <=2
- •Anticipated survival >=3 months
- •For men and women of child-producing potential, use of effective contraceptive methods during the study and for one month after 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 for the required assessments
排除标准
- •Pregnant or nursing women
- •Treatment with chemotherapy, monoclonal antibody, or radiotherapy within 28 days before entering the study
- •Participation in any investigational drug study within 28 days before CNF2024 administration
- •Patients with secondary malignancy requiring active treatment (except hormonal therapy)
- •Active symptomatic bacterial, fungal, or viral infection including active HIV or viral (A, B, or C) hepatitis
- •Problems with swallowing or malabsorption
- •Diarrhea (excess of 2-3 stools/day above normal frequency in the past month)
- •Gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis
- •Major surgery of the stomach or small intestine
- •Adrenal dysfunction
- •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 the study's endpoints
研究组 & 干预措施
CNF2024
Experimental
干预措施: CNF2024 (BIIB021) (Drug)
结局指标
主要结局
Safety and toxicity (maximum tolerated dose (MTD))
时间窗: 4 week periods until MTD is reached
Pharmacokinetics
时间窗: Dosing period
Pharmacodynamics
时间窗: Dosing period
次要结局
- To determine clinical and hematological response(Study Duration)
- To determine the recommended Phase 2 dose(Study duration)
研究者
研究点 (2)
Loading locations...
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