JPRN-jRCT2011220022招募中2 期
A phase II study of eribulin monotherapy for advanced extramammary Paget's disease - EMPHASIS Study
Yanagi Teruki0 个研究点目标入组 18 人开始时间: 2022年10月28日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1)Pathologically proven (by histology or cytology) EMPD,surgically incurable
- •(2)At least 20 years of age at time of informed consent
- •(3)Can provide written informed consent voluntarily
- •(4)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •(5)At least 1 measurable lesion per RECIST (Version 1.1)
- •(6)Results of most recent laboratory tests performed within 14 days before enrollment (can be on the same day of the week as the enrollment day within 2 weeks before enrollment) meet the following criteria:
- •a) Neutrophil count >= 1500/mm3L
- •b) Platelet count >= 100,000/mm3L
- •c) Hemoglobin level >= 10 g/dL
- •d) Serum creatinine <= 3.0 x upper limit of normal (ULN)
- •e) Total bilirubin or direct bilirubin <= 1.5 x ULN
- •f) AST andALT <= 3.0 x
排除标准
- •(1)History of hypersensitivity to any ingredient of the study drug
- •(2)Judged to be at high medical risk due to poorly controlledserious comorbidity, non-malignant systemic disease, or poorly controlled active infection. This could include, but is not limited to, the following examples:
- •-Peripheral neuropathy
- •-Interstitial pneumonia
- •-Psychiatric disorder that impedes patient's ability to sign the Informed Consent Form
- •(3)Received anticancer drug within 4 weeks before starting study treatment
- •(4)Received radiotherapy within 4 weeks before starting study treatment
- •(5)Received a blood transfusion (platelets or red blood cells) within 4 weeks before starting study treatment
- •(6)Received a live viral or bacterial vaccine within 4 weeks before starting study treatment
- •(7)Received study drug(including Unapproved or off-labeled drug) within 4 weeks before starting study treatment
- •(8)Patients with multiple cancers(Patients with completely resected basal cell carcinoma, stage I spinous cell carcinoma, intraepithelial carcinoma, intramucosal carcinoma or superficial bladder cancer, or other cancer that has not recurred for at least 2 years may be enrolled.)
- •(9)Patients with central nervous system metastases
- •(10)Known human immunodeficiency virus (HIV) infection
- •(11)Hepatitis B virus surface antigen (HBsAg) positive, or individuals with known or suspected active hepatitis C virus (HCV) infection. Note: Patients who have tested positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) are eligible for enrollment, but their HBV nucleic acid test (HBV-DNA quantification) results must be below the limit of detection. Patients who are positive for hepatitis C virus antibody (HCVAb) must have HCV nucleic acid test (HCV-RNA quantification) results below the limit of detection.
- •(12)Pregnant, possibly pregnant, or does not consent to use contraception for the 3-month period frominformed consent to the end of the study treatment
- •(13)Participating or planning to participate in another clinical trialor interventional study
- •(14)Deemed bytheinvestigator to be unsuitable to participate in the study for any other reason
研究者
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