A Phase 1 Study of Halichondrin B Analog (E7389) in Combination With Cisplatin in Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Maximum tolerated dose determined by dose-limiting toxicity graded according to the NCI CTCAE version 4.0
研究概览
简要总结
This trial is studying the side effects and best dose of eribulin mesylate and cisplatin in treating patients with advanced solid tumors.Drugs used in chemotherapy, such as eribulin mesylate and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
详细描述
Primary Objectives:
I. To determine the maximum tolerated dose of E7389 and cisplatin in patients with advanced solid tumors.
II. To determine the safety and toxicity of this regimen in these patients. III. To determine the pharmacokinetics of this regimen in these patients.
Outline: This is a multicenter, dose-escalation study. Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for up to 8 weeks.
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 confirmed malignant solid tumor
- •Advanced disease, meeting both of the following criteria: Metastatic or unresectable disease and standard curative or palliative measures do not exist or are no longer effective.
- •No known active brain metastases
- •Life expectancy > 3 months
- •ECOG performance status 0-2
- •Bilirubin normal
- •No uncontrolled intercurrent illness including, but not limited to, any of the following: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or social situation that would limit study compliance.
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Recovered from prior therapy
- •No prior chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C).
- •No prior targeted therapy within the past 4 weeks
- •No prior immunotherapy within the past 4 weeks
- •No prior radiotherapy within the past 4 weeks.
- •No more than 2 prior chemotherapy regimens for advanced solid tumors.
- •No other concurrent investigational agents. Bisphosphonate therapy (e.g., pamidronate or zolendronate) is not considered investigational therapy.
- •No concurrent antiretroviral therapy for HIV-positive patients.
- •No other concurrent anticancer agents or therapies.
- •Tumor has spread to other parts of the body or cannot be removed by surgery.
- •More than 4 weeks since chemotherapy, biological therapy, or radiation therapy.
- •No more than two previous chemotherapy regimens for advanced solid tumor.
- •WBC >= 3,000/mm^3
- •Platelet count >= 100,000/mm^3
- •Creatinine clearance >= 60 mL/min
- •Absolute neutrophil count >= 1,500/mm³
- •AST and ALT =< 2.5 times upper limit of normal
- •No prior cumulative cisplatin dose > 300 mg/m^2
- •No preexisting neuropathy <= grade 2
- •Not pregnant or nursing
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1.
干预措施: eribulin mesylate (Drug)
Arm 1
Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1.
干预措施: cisplatin (Drug)
Arm 1
Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1.
干预措施: laboratory biomarker analysis (Other)
Arm 1
Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1.
干预措施: pharmacological study (Other)
结局指标
主要结局
Maximum tolerated dose determined by dose-limiting toxicity graded according to the NCI CTCAE version 4.0
时间窗: 28 days
次要结局
- Survival(From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 8 weeks)
- Time to failure(Up to 8 weeks)