NL-OMON32470尚未招募不适用
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 - 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 must have a histologically or cytologically confirmed advanced solid tumor that has progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy). Patients with measurable tumours according to RECIST are desirable but not essential for inclusion.
- •2. Patients must be aged >= 18 years
- •3. Patients must have an ECOG Performance Status of 0, 1, or 2
- •4. Patients must have adequate renal function as evidenced by serum creatinine <=135 µM/L (<= 1.5 mg/dL) or creatinine clearance >= 40 mL/minute (min)
- •5. Patients must have adequate bone marrow function as evidenced by absolute
- •neutrophil count (ANC) >= 1.5 x 109/L and platelet count >= 100 x 109/L
- •6. Patients must have adequate hepatic function as evidenced by bilirubin <= 1.5 times the upper limit of normal (ULN) and alkaline phosphatase, alanine aminotransferase
- •(ALT), and aspartate aminotransferase (AST) <= 3 x ULN (in the case of liver
- •metastases <= 5 x ULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase
- •7. Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or below, except for stable sensory neuropathy <= Grade 2 and alopecia
- •8. Patients must be willing and able to comply with the study protocol for the duration of the study
- •9. Patients must give written informed consent prior to any study-specific screening
- •procedures with the understanding that the patient may withdraw consent at any time without prejudice
排除标准
- •1. 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
- •2. Have had radiation therapy encompassing > 30% of marrow
- •3. Have received prior treatment with mitomycin C or nitrosourea
- •4. Have had major surgery within 4 weeks before starting study treatment
- •5. Patients with pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen
- •6. 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
- •7. Patients with meningeal carcinomatosis
- •8. 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
- •9. 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
- •10. Patients with severe/uncontrolled intercurrent illness/infection
- •11. Significant cardiovascular impairment (history of congestive heart failure > NYHA
- •grade II, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia)
- •12. Patients with organ allografts requiring immunosuppression
- •13. Patients with known positive HIV status
- •14. Patients with pre-existing neuropathy > Grade 2
- •15. Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical
- •16. Patients who participated in a prior eribulin clinical trial, whether or not they received eribulin (E7389).
- •17. Patients with other significant disease or disorders that, in the Investigator*s opinion, would exclude the patient from the study.
研究者
相似试验
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 TherapiesDrug Metabolism10027656CancerNL-OMON33844Eisai10
进行中（未招募）
不适用
An Open-Label, Non-Randomized, Single center Study to Evaluate the Use of Zoledronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women with ER+ and/or PgR+ Breast Cancer Receiving Letrozole as Adjuvant TherapyEUCTR2004-004796-11-DEKlinikum Augsburg100
进行中（未招募）
不适用
A study comparing cholic acid capsules that are not currently available, with cholic acid capsules that are currently available, to check that they are as safe and work just as well in treating children born with a birth defect inherited from their parents, which means that their body cannot make normal bile acidsPatients with inborn errors of bile acid synthesis and metabolismMedDRA version: 14.0Level: PTClassification code 10070882Term: Inborn error in primary bile acid synthesisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-004491-10-Outside-EU/EEAAsklepion Pharmaceuticals, LLC16
已完成
不适用
Single-center, open-label, non-randomized study investigating the excretion balance, pharmacokinetics and metabolism of a single oral dose of [14C]-labeled RO5285119 in healthy male subjectsAutism Disorder10029305ASDAsperger's syndromeNL-OMON41196F. Hoffmann-La Roche Ltd6
已完成
Unknown
A Clinical Study to check the safety and effectiveness of AVL200 Modular Intraocular Lens.CTRI/2023/05/052664ATIA VISION,INC100