NL-OMON32968已完成不适用
An Open-Label Phase I Study to Assess the Effect of Rifampicin in the Pharmacokinetics of Eribulin Mesylate (E7389) in Subjects with Advanced Solid Tumours - E7389-E044-111
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Eisai
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Histologically or cytologically confirmed advanced solid tumors
- •that have progressed following standard therapy or for which no
- •standard therapy exists (including surgery or radiation therapy)
- •Adequate renal function as evidenced by serum creatinine
- •<= 2.0 mg/dL (<= 176 µmol/L) or calculated creatinine clearance
- •>= 40 mL/minute per the Cockcroft and Gault formula
- •Adequate liver function as evidenced by bilirubin <= 1.5 times the
- •upper limit of normal (ULN) and alkaline phosphatase (ALP),
- •alanine transaminase (ALT), and aspartate transaminase (AST)
- •<= 3 times the ULN (in the case of liver metastasis <= 5 times
- •ULN). In case ALP > 3 times the ULN (in the absence of liver
- •metastasis) or > 5 times the ULN (in the presence of liver
- •metastasis), and the subject is also known to have bone
- •metastasis, the liver specific ALP must be separated from the total
- •and used to assess the liver function instead of the total ALP.
- •- Age >=18 years.
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
排除标准
- •Subjects with a hypersensitivity to halichondrin B and/or
- •halichondrin B chemical derivative or a hypersensitivity to
- •Subjects with prior participation in an eribulin clinical study, even
- •if not previously assigned to eribulin treatment
- •Subjects with pre-existing neuropathy > Grade 2
- •Subjects receiving any medication, dietary supplements or other
- •compounds or substances known to inhibit or induce CYP3A4 at
- •the time the study starts
研究者
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