A Phase I Study of GRN163L in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 4
- 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 in combination with a standard paclitaxel/carboplatin regimen to patients with advanced or metastatic non-small cell lung cancer.
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
- •Histologically or cytologically confirmed diagnosis of NSCLC
- •Stage IIIb with pleural effusion, Stage IV, or recurrent disease
- •Measurable or evaluable disease by RECIST criteria
- •ECOG performance status 0-1
- •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
- •More than 2 prior chemotherapy regimens for metastatic disease (prior adjuvant chemotherapy is allowed)
- •Tumor progression during treatment with paclitaxel (refractory to paclitaxel)
- •Taxane-based regimen within 12 weeks
- •Any systemic therapy for cancer within 4 weeks
- •Anti-platelet therapy within 2 weeks, other than low dose aspirin prophylaxis therapy
- •Therapeutic anticoagulation therapy except for low dose warfarin (eg, 1 mg by mouth per day)
- •Radiation therapy within 3 weeks
- •Major surgery within 4 weeks (central line placement is allowed)
- •Prolongation of PT or aPTT > the ULN or fibrinogen < the LLN
- •History of or active central nervous system metastatic disease
- •Any other active malignancy
- •Active or chronically recurrent bleeding (eg, active peptic ulcer disease)
- •Clinically significant infection
- •Active autoimmune disease requiring immunosuppressive therapy
- •Clinically significant cardiovascular disease or condition
研究组 & 干预措施
Single Arm Trial
Patients will be enrolled in the order of confirmation of eligibility. Dose cohorts will be filled sequentially with a minimum of 3 patients. Once assigned to a dose cohort, each patient will continue to be treated at the same dose level throughout the course of the study.
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 and efficacy(Baseline to end of treatment)