NCT00732056已完成1 期
A Phase I/II Study of GRN163L in Combination With Paclitaxel and Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer
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
- 24
- 试验地点
- 2
- 主要终点
- Safety, MTD, efficacy
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose (MTD) of GRN163L in combination with paclitaxel and bevacizumab in patients with locally recurrent or metastatic breast cancer (MBC)
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
- Na
- 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 adenocarcinoma of the breast with measurable locally recurrent or metastatic disease
- •May have had one prior non-taxane chemotherapy regimen for metastatic disease
- •If HER2 positive, must have had prior treatment with trastuzumab (Herceptin®)
- •If previously treated with an anthracycline, anthracenedione, or trastuzumab must be tested by MUGA scan or echocardiogram and have LVEF ≥ 50%
- •Must have recovered from most recent radiation treatment or surgical procedure
- •ECOG performance status of 0 or 1
- •Life expectancy ≥ 3 months
排除标准
- •Locally recurrent disease amenable to resection with curative intent
- •Prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior to first study drug administration
- •Investigational therapy within 4 weeks prior to first study drug administration
- •Prior hormonal therapy within 2 weeks prior to first study drug administration
- •Prior radiotherapy within 2 weeks prior to first study drug administration
- •Cytotoxic chemotherapy within 2 weeks prior to first study drug administration
- •Therapeutic anticoagulation or regular use of anti-platelet therapy within 2 weeks prior to first study drug administration NOTE: Low-dose anticoagulant therapy to maintain patency of a vascular access device is allowed.
- •Prolongation of PT or INR, aPTT > ULN, or fibrinogen < LLN
- •Active or chronically current bleeding (eg, active peptic ulcer)
- •Clinically significant cardiovascular or cerebrovascular disease including
- •Any history of:
- •Cerebrovascular disease including TIA, stroke or subarachnoid hemorrhage
- •Ischemic bowel
- •Within the last 12 months:
- •Unstable angina
- •NYHA grade II or greater CHF
- •Grade 2 or greater peripheral vascular disease
- •Active at study entry:
- •Uncontrolled hypertension defined as SBP > 160 or DBP > 90
- •Uncontrolled or clinically significant arrhythmia
- •Clinically relevant active infection
- •Nonhealing wound or fracture
- •Serious co-morbid medical conditions, including cirrhosis and chronic obstructive or chronic restrictive pulmonary disease
- •Active autoimmune disease requiring immunosuppressive therapy
- •Known positive serology for HIV
- •Prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer, or other cancer for which the patient has been disease-free for at least 3 years
- •Any other severe, acute, or chronic medical or psychiatric condition, laboratory abnormality, or difficult complying with protocol requirements that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for this study
研究组 & 干预措施
1
Experimental
3+3 cohort dose escalation
干预措施: GRN163L (Drug)
结局指标
主要结局
Safety, MTD, efficacy
时间窗: First 4 weeks
次要结局
- PK and efficacy(Baseline to end of treatment)
研究者
研究点 (2)
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