JPRN-UMIN000045953招募中未知
Therapeutic drug monitoring study for avoiding severe neutropenia of amrubicin therapy based on the exposure-response relationship with pharmacokinetic/pharmacodynamic parameters. - TDM study of Amrubicin
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 44
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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) Patients who have received treatment with amrubicin hydrochloride in the past. 2) Patients who require concomitant use of other anticancer drugs, immunotherapy, or concomitant use of thoracic irradiation. (3) Patients who have received anticancer drugs (excluding immune check inhibitors) within 3 weeks prior to enrollment or within 5 times the half-life of other therapies, whichever is shorter, or who have not recovered from the toxicity of these previous therapies (grade 1 or up to baseline). (4) Patients who have not recovered from the toxicity of radiation or major surgery performed prior to the start of enrollment (Grade 1 or baseline). (5) Patients with symptomatic unstable brain metastasis or central nervous system invasion (6) Patients currently participating in other clinical trials. (6) Patients currently participating in other clinical trials, but not excluded if they are undergoing follow-up after the completion of the trial or if participation in this clinical trial is permitted in the relevant trial. (7) Female patients who may be pregnant, or pregnant or lactating women. (8) Active infectious diseases requiring systemic administration of antimicrobial agents (prophylactic administration is not excluded) Fluid retention (pleural effusion, pericardial effusion) that requires puncture and drainage within 14 days prior to enrollment and continuous treatment after the procedure Poorly controlled heart failure, coronary artery disease, arrhythmia, arteriovenous thrombosis, cerebral infarction, diabetes mellitus, autoimmune disease, psychiatric symptoms Complications of interstitial pneumonia or pulmonary fibrosis evident on chest x-ray (including pre-existing conditions) (9) COVID-19 positive patients (10) HIV-positive patients
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