JPRN-jRCT2080223823
招募中
1 期
A phase 1 study of E7130 in subjects with solid tumor
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Eisai Co., Ltd.
- 入组人数
- 95
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •(1\)Participants who have provided voluntary written consent for participation in this clinical study
- •(2\) Participants to whom the rules for complying with this clinical study have been adequately explained, and who intend to and can comply with those rules
- •(3\)Participants age \>\= 20 years at the time of informed consent
- •(4\) Part 1:Subjects with a histological and/or cytological diagnosis of solid tumor who failed standard therapies, or for which no appropriate treatment is available.
- •Part 2(SCCHN): Histologically diagnosed, locally advanced or unresectable or metastatic squamous cell carcinoma of the head and neck (SCCHN). Up to 3 prior systemic therapies in advanced or metastatic setting.
- •Part 2(UC) Histologically or cytologically diagnosed, locally advanced or unresectable or metastatic urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis. Prior systemic therapies of platinum agent and immunocheckpoint inhibitor, and up to 3 regimens in advanced or metastatic setting.
- •(5\)Participants with adequate function of major organs
- •a.Hemoglobin \>\= 9\.0 grams per deciliter
- •b.Neutrophil count \>\= 1\.5 x 10^3/microliter
- •c.Platelet count \>\= 10 x 10^4/microliter
排除标准
- •(1\)Medical history of clinically significant cardiovascular impairment:
- •a. Congestive heart failure greater or equal to than New York Heart Association Class II
- •b. Unstable angina pectoris, myocardial infarction or stroke within 6 months before of the first dose of study drug
- •c. Prolongation of corrected QT interval to \> 480 milliseconds (ms) (Fridericia method)
- •d. Arrhythmias associated with hemodynamic instability within 6 months
- •(2\) Concomitant systemic infection requiring
- •(3\)Participants who test positive for human immunodeficiency virus (HIV antibody)
- •(4\)Active viral hepatitis (B or C) (\*) as demonstrated by positive serology or requiring treatment
- •(\*)hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti\-HBs)/hepatitis B core antibody (HBcAb) and anti\-hepatitis C virus (HCV) antibody test. Participants who are anti\-HBs/HBcAb (\+) with less than 20 international units per milliliter (IU/ml) hepatitis B virus\-deoxyribonucleic acid (HBV\-DNA) are eligible.
- •(5\)Effusion requiring drainage (Note: participants whose symptom has been treated and stable for 2 weeks prior to the first administration of the study drug, are eligible)
结局指标
主要结局
未指定
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