NCT00718601已完成1 期
A Phase I Study of GRN163L in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory 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
- 40
- 试验地点
- 3
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
The purpose of this study is to determine safety and the maximum tolerated dose (MTD) of GRN163L and Velcade with and without Decadron 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
- 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
- •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%
- •Fully recovered from any previous cancer treatments and/or major surgery
排除标准
- •Prior allogeneic bone marrow transplant, including syngeneic transplant
- •Bone marrow transplant within 12 weeks prior to study
- •Known intracranial disease or epidural disease
- •Inability to tolerate Velcade
- •Inability to tolerate Decadron
- •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
- •Any other cancer therapy within 4 weeks prior to study, with nitrosourea 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
Experimental
3+3 cohort dose escalation
干预措施: Imetelstat Sodium (GRN163L) (Drug)
结局指标
主要结局
Maximum tolerated dose
时间窗: First 3 weeks
次要结局
- Safety, PK and efficacy(Baseline to 28 days after last dose of treatment)
研究者
研究点 (3)
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