NCT01013818终止1 期
A Phase 1, Multi-Center, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HGS1029 in Subjects With Relapsed or Refractory Lymphoid Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 5
- 主要终点
- Type, frequency and severity of adverse events
研究概览
简要总结
The purpose of this study is to determine if HGS1029 is safe and well tolerated in patients with relapsed or refractory lymphoid malignancies.
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
- •Confirmed relapsed/refractory lymphoid malignancies
- •Previously treated with at least 2 therapeutic regimens
- •ECOG performance <
- •Life expectancy of at least 3 months
- •Adequate renal function
- •Adequate hematologic status
- •Adequate liver function
- •Transfusion independent
排除标准
- •Received other therapy (biological or drug) to treat cancer within 4 weeks prior to starting treatment with HGS1029 or who exhibit persistent clinical evidence of cancer treatment toxicity
- •The use of systemic corticosteroids within 1 week of starting treatment with HGS1029
- •Evidence of active bacterial, viral or fungal infection within 2 weeks before starting treatment with HGS1029
- •Known HIV infection
- •Positive for hepatitis B surface antigen or positive hepatitis C antibody
- •Grade 2 or greater neuropathy
- •Pregnant female or nursing mother
- •Males or females who do not agree to use effective contraception during the study and through at least 30 days after the last dose of HGS1029
研究组 & 干预措施
HGS1029
Experimental
干预措施: HGS1029 (Drug)
结局指标
主要结局
Type, frequency and severity of adverse events
时间窗: 1 year
次要结局
- Measure pharmacokinetic profile(1st two months of the study)
- Evaluation of pharmacodynamics(1st two months of the study)
- Evaluation of possible anti-tumor activity(Every 2 months while on study)
研究者
研究点 (5)
Loading locations...
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