A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and MTD of GRN163L in Patients With Refractory or Relapsed Solid Tumor Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Safety, DLT, 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 of GRN163L administration in treating patients with refractory or relapsed solid tumor malignancies.
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
- •18 years of age or older
- •Male or female
- •Measurable or evaluable solid tumor malignancy
- •Relapsed, refractory, locally advanced, or metastatic disease
- •Disease refractory to or not amenable to standard therapy
- •Karnofsky performance status 70-100%
- •Life expectancy 3 months or greater
排除标准
- •Pregnant or lactating women
- •Primary central nervous system(CNS) malignancy or active CNS metastases
- •Hematologic malignancy
- •Chemotherapy within 4 weeks prior to study
- •Mitomycin C, nitrosoureas within 6 weeks prior to study
- •High dose chemotherapy with stem cell support within 6 months prior to study
- •Signal transduction inhibitors, monoclonal antibodies, etc. within 4 weeks prior to study
- •Systemic hormonal therapy within 4 weeks prior to study
- •Anticoagulant therapy, antiplatelet therapy within 2 weeks prior to study
- •Radiotherapy within 4 weeks prior to study
- •Significant cardiovascular disease
- •Serious/active infection
- •Major surgical procedures within 2 weeks
研究组 & 干预措施
Dose escalation
Treatment Schedule 3 will consist of dosing on Days 1, 4, 8, and 11 of each 21 day cycle (3 weeks equals 1 cycle) and Treatment Schedule 4 will consist of dosing on Day 1 of each 28 day cycle (4 weeks equals 1 cycle)
干预措施: Imetelstat Sodium (GRN163L) (Drug)
结局指标
主要结局
Safety, DLT, and MTD
时间窗: Measured during the first cycle of treatment
次要结局
- PK profile and disease response(Within the first 2 cycles of treatment)