NL-OMON33844尚未招募不适用
An Open-Label, Non-Randomized, Single-Center Study to Determine the Metabolism and Elimination of 14C-E7080 in Patients with Advanced Solid Tumors or Lymphomas, who are Unsuitable For, or Have Failed, Existing Therapies - NVT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Eisai
- 入组人数
- 10
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
- •1. Patients with histologically and/or cytologically confirmed solid tumor or lymphoma who are resistant/ refractory to approved therapies or for whom no appropriate therapies are available. Patients with measurable tumors according to RECIST are desirable but not essential for inclusion.
- •2. All previous treatment (including surgery and radiotherapy) must have been completed at least four weeks prior to study entry and any acute toxicity must have resolved
- •3. Aged >= 18 years
- •4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- •5. Able to take oral study medication
- •6. Give written informed consent to participate in the study
- •7. Willing and able to comply with the study protocol for the duration of the study.
排除标准
- •1. Patients with brain or subdural metastases, 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 and/or symptoms of brain metastases must be stable for at least 4 weeks.
- •2. Patients with meningeal carcinomatosis
- •3. Any of the following values for laboratory parameters:
- •a) hemoglobin < 9 g/dl (5.6 mmol/L)
- •b) neutrophils <1.5 x 109/L
- •c) platelets <100 x 109/L
- •d) PT (or INR) and PTT > 1.5 x the upper limit of normal (ULN)
- •e) serum bilirubin >1.5 x ULN
- •f) other liver parameters >3 x ULN
- •g) creatinine clearance < 60 mL/min per the Cockcroft and Gault formula
- •4. Uncontrolled infections
- •5. Significant cardiovascular impairment (history of congestive heart failure > NYHA Class II, unstable ischemic heart disease including a myocardial infarction within six months of study start, or serious cardiac arrhythmia)
- •6. Patients with marked baseline prolongation of QT/QTc interval (QTc interval >= 500 msec) using the Fridericia method
- •7. Any treatment with an investigational drug within the last 30 days
- •8. Women who are pregnant or breast-feeding;women of childbearing potential with a positive pregnancy test at screening or no pregnancy test. Women of child-bearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator (including two forms of contraception, one of which must be a barrier method). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-child-bearing potential. Fertile males with female partners of child-bearing potential who are not willing to use contraception, or whose female partners are not using adequate contraceptive protection, are excluded.
- •9. Proteinuria > 1+ on bedside testing
- •10. History of gastrointestinal malabsorption
- •11. Surgery within four weeks of start of study treatment
- •12. Bleeding or thrombotic disorders or use of an anticoagulant, such as warfarin, with a therapeutic international normalization ratio (INR). Aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), and low molecular weight heparin (LMWH) are permissible but should be used with caution.
- •13. Poorly controlled hypertension (defined as a change in hypertensive therapy within three months of study start) or patients diagnosed with hypertension (defined as a repeat blood pressure measurement of 160/90 mmHg or higher) at screening
- •14. Previous E7080 therapy
- •15. History of alcoholism, drug addiction, psychiatric or psychological condition, or social situation which, in the opinion of the investigator, would impair study compliance
- •16. History of allergic reactions attributed to compounds of similar chemical or biological composition to E7080
- •17. Other significant disease or disorder that, in the Investigator*s opinion, would exclude the patient from the study
- •18. Legal incapacity
研究者
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