NL-OMON51840撤回不适用
An Investigation of the Mass Balance, Pharmacokinetics, Excretion and Metabolism of [14C]-Nanatinostat in Patients with Advanced Solid Tumors: A Phase 1, Open-Label Study - CS0383-210288 VT3996-101
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 6
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. Men or women that are at least 18 years of age at the time of informed
- •2. Has histologically confirmed metastatic or advanced solid tumors refractory
- •to standard therapy, and for whom no standard curative therapy exists.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status: 0-2.
- •4. Adequate laboratory parameters (in absence of transfusion support within
- •three weeks or growth factor within two weeks of Screening), including:
- •Absolute neutrophil count (ANC) >=1500/mm3 = 1.5 × 109/L.
- •Platelets count >=90,000/mm3 = 90 × 109/L.
- •Hemoglobin >=9.0 g/dL.
- •Aspartate aminotransferase (AST), alanine aminotransferase (ALT) <=2.5 × upper
- •limit of normal (ULN), or < 5x ULN in the presence of liver metastases.
- •Total bilirubin <=1.5 × ULN unless considered due to Gilbert*s syndrome, in
- •which case, <=3.0 × ULN.
- •Estimated glomerular filtration rate (eGFR) >=60 mL/min by CKD-EPI equation.
- •Serum potassium, magnesium, and corrected calcium outside normal limits for
- •institution that are assessed as clinically significant by the Investigator
- •should be treated to correct abnormalities with confirmation on repeat lab
- •5. Life expectancy >3 months, as determined by the treating physician.
排除标准
- •1. Known history of central nervous system and/or leptomeningeal disease.
- •2. Prior treatment with [14C]-nanatinostat or history of allergic reactions
- •attributed to compounds
- •of similar chemical or biologic composition to [14C]-nanatinostat.
- •3. Inability to take or tolerate oral medication.
- •4. Any gastrointestinal, liver, or kidney condition that may affect drug
- •absorption and metabolism.
- •5.Is currently participating in or has participated in an interventional study
- •of an investigational agent or has used an investigational device within 4
- •weeks or 5 half-lives prior to dosing, whichever is longer.
研究者
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