JPRN-jRCTs031180073已完成2 期
phase 2 study of the combination therapy, docetaxel and trastuzumab, for advanced extramammary Paget's disease. - EMPD-HER2DOC
Funakoshi Takeru0 个研究点目标入组 13 人开始时间: 2019年1月9日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
研究概览
简要总结
This prospective trial provided first evidence for the treatment of metastatic EMPD. The ORR after 3 cycles was 76.9 % (n = 10/13; 90% CI: 50.5-93.4) including 5 complete responses (38.5%). The lower bound for the 90% CI was greater than the pre-specified threshold of the ORR (35%), and the primary study hypothesis (ORR > 35%) was demonstrated. Docetaxel and trastuzumab combination treatment demonstrated a favorable clinical effect and acceptable tolerability that it can be a good treatment option for HER2
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) Have histologically confirmed extramammary Paget's disease as follows.
- •unresectable or metastatic disease
- •Her-2 positive
- •2) Provide written informed consent for the study.
- •3) Be male or female subjects, age 20 years or older on day of signing consent.
- •4) LVEF >= 50%
- •5) Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- •6) Have the presence of at least one measurable lesion by CT or MRI per RECIST 1.1 criteria.
- •7) Have laboratory parameters within Protocol-defined range.
- •a) Absolute neutrophil count >= 1,500 /mm3
- •b) Platelets >= 100,000 /mm3
- •c) Hemoglobin >= 10 g/dL
- •d) Bilirubin <= 2.0 mg/dL
- •e) AST and ALT <= 100 IU/L
- •f) Serum creatinine <= 1.5mg/dL
- •8) Prior therapy for extramammary Paget's disease was completed at least 4 weeks before treatment initiation.
排除标准
- •1) Have a history of hypersensitivity to components of the chemotherapeutic drugs.
- •2) Women who may possibly be pregnant or pregnant.
- •3) Patients with severe cardiac dysfunction.
- •4) Has known active central nervous system (CNS) metastasis.
- •5) Has uncontrolled disease that might confound the results of the study, or is not best interest of the subject to participate, in the opinion of the treating investigator.
研究者
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