An Open-Label, Non-Randomized, Single-Center Study to Determine the Metabolism and Elimination of Carbon-14 Labeled Eribulin Acetate (14C-Eribulin) in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Excretion Balance of Radio-labeled 14C-eribulin: Total Recovery of Radioactive Dose in Urine and Feces.
研究概览
简要总结
The purpose of this study is to determine the metabolism and elimination of carbon-14 labeled eribulin acetate (14C-eribulin) in patients with advanced solid tumors.
详细描述
The study will be conducted in two phases, the initial Study phase to administer the radio-labeled 14C-eribulin and collection of PK samples, and the Extension Phase when the patients will continue to receive non-radio-labeled eribulin. In the initial Study phase, patients will receive a single 2 mg flat dose of 14C-eribulin (approximately 80 to 90 microCuries) administered on Cycle 1 Day 1 as an intravenous (IV) bolus injection or infusion over 2-5 minutes. Following this initial dose, patients will remain in the research unit until Day 8 to complete sample collections of urine, blood and feces for PK analysis and determination of 14C-eribulin concentrations between Days 1 and 8.
On Day 8 patients will be re-assessed and discharged, and return on day 15 for physical exam, adverse event evaluation, and lab tests. The patients will then enter the Extension Phase of the study and continue to receive on-radio-labeled eribulin at a dose of 1.4 mg/m^2 on Days 1 and 8 of every 21 day cycle.
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
- 未提供
排除标准
- •Patients who have received any of the following treatments within the specified period before treatment start:
- •chemotherapy, radiation, or biological therapy within three weeks
- •hormonal therapy within one week
- •any investigational drug within 4 weeks
- •systemic unconventional or alternative therapies including, but not limited to, herbal remedies within 4 weeks
- •Have had radiation therapy encompassing > 30% of marrow.
- •Have received prior treatment with mitomycin C or nitrosourea.
- •Have had major surgery within 4 weeks before starting study treatment
- •Patients with pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
- •Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (e.g., radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks.
- •Patients with meningeal carcinomatosis.
- •Patients who are receiving anti-coagulant therapy with warfarin or related compounds, other than for line patency, and cannot be changed to heparin-based therapy, are not eligible. If a patient is to continue on mini-dose warfarin, then the prothrombin time (PT) or international normalized ratio (INR) must be closely monitored.
- •Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Peri-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- •Patients with severe/uncontrolled intercurrent illness/infection.
- •Significant cardiovascular impairment (history of congestive heart failure > New York Heart Association (NYHA) grade II, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia).
- •Patients with organ allografts requiring immunosuppression.
- •Patients with known positive HIV status.
- •Patients with pre-existing neuropathy > Grade
- •Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.
- •Patients who participated in a prior eribulin clinical trial, whether or not they received eribulin (E7389).
- •Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study.
研究组 & 干预措施
1
干预措施: eribulin (Drug)
结局指标
主要结局
Excretion Balance of Radio-labeled 14C-eribulin: Total Recovery of Radioactive Dose in Urine and Feces.
时间窗: 312 hours postdose
Pharmacokinetics: AUC (0-t) for Total Radioactivity in Plasma
时间窗: Between Days 1 and 8 of Cycle 1
Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring total radioactivity exposure.
Pharmacokinetics AUC (0-t) for Eribulin in Plasma
时间窗: Between Days 1 and 8 of Cycle 1
Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring exposure to eribulin.
次要结局
未报告次要终点