NCT00594126已完成1 期
A Phase 1 Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of GRN163L in Patients With Refractory or Relapsed Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Safety and MTD
研究概览
简要总结
The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered to patients with refractory or relapsed multiple myeloma.
详细描述
GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.
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 diagnosis of multiple myeloma (either secretory or nonsecretory disease)
- •Relapsed or refractory disease
- •At least two prior treatment regimens
- •ECOG performance status 0-2
- •Adequate hepatic/renal function and platelet count
- •If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction > 50%
排除标准
- •Prior allogeneic bone marrow transplant, including syngeneic transplant
- •Known intracranial disease or epidural disease
- •Prior malignancy (within the last 3 years)
- •Clinically significant cardiovascular disease or condition
- •Active or chronically recurrent bleeding (eg, active peptic ulcer disease
- •Prolongation of PT or aPTT > the ULN or fibrinogen < the LLN
- •Clinically relevant active infection
- •Serious co-morbid medical conditions, including cirrhosis and chronic obstructive or chronic restrictive pulmonary disease
- •Symptomatic hyperviscosity syndrome
- •Any other cancer therapy within 3 weeks prior to study, except for mitomycin C, nitrosoureas, or high-dose chemotherapy with stem cell support within 6 weeks prior to study
- •Investigational therapy within 4 weeks prior to study
- •Anti-platelet therapy within 2 weeks prior to study, other than low dose aspirin prophylaxis therapy and low dose heparin administration for management of IV access devices
- •Radiation therapy within 4 weeks prior to study
- •Major surgery within 4 weeks prior to study
- •Active autoimmune disease requiring immunosuppressive therapy
- •Known positive serology for HIV
研究组 & 干预措施
1
Other
3+3 cohort dose escalation
干预措施: Imetelstat Sodium (GRN163L) (Drug)
结局指标
主要结局
Safety and MTD
时间窗: First 3 weeks
次要结局
- PK, PD, and efficacy(Baseline to end of treatment)
研究者
研究点 (3)
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