CTRI/2020/06/026176尚未招募未知
To study the pharmacokinetics of Nivolumab in Indian patients with solid tumours
Advanced Cancer for Treatment Research and Education in cancer0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Any cancer patient where nivolumab is indicated
- •2.Life expectancy greater than or equal to 3 months
- •3.Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1(less than 2)
- •4.Adequate organ and marrow function as defined below:
- •a.Adequate organ functions Absolute neutrophil count greater than 1,500/per microliter
- •b.Platelets greater than 100,000/per microliter
- •c.Hemoglobin greater than or equal to 9.0 g/dL
- •d.Total bilirubin less than or equal to 1.5 times the institutional upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin less than 3.0 mg/dL)
- •e.Aspartate Aminotransferase (SGOT)/ Alanine Aminotransferase (SGPT) less than 3 X institutional ULN
- •f.Creatinine less than or equal to 1.5 X institutional ULN OR Creatinine clearance greater than 40 mL/min for patients with creatinine Levels above institutional normal (calculated using the Cockcroft-Gault formula below)
- •5.Patients willing to give written informed consent
排除标准
- •1.History of severe hypersensitivity reaction to other antibody products
- •2.Adverse drug reactions (ADRs) associated with prior treatments or surgical therapy with a possible influence on the study outcome
- •3.Multiple primary cancers
- •4.Any active, known or suspected autoimmune disease
- •5.Documented history of any chronic or recurrent autoimmune disease or requirement for systemic steroids or immunosuppressants
- •6.Uncontrolled brain metastases.
- •7.History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- •8.Positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating ongoing acute or chronic infection.
- •9.Requiring systemic treatment with either corticosteroids (greater than 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study drug administration.
- •10.Pregnant or currently breastfeeding.
- •11.Receiving any other anticancer therapy
研究者
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