JPRN-jRCT2080223202未知1 期
A Phase I clinical trial to investigate the safety and tolerability of NK105 when co-administered with carboplatin once per week to Japanese patients with advanced solid cancers.
ippon Kayaku Co., Ltd.0 个研究点目标入组 18 人开始时间: 2016年5月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 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
- •A solid cancer has been confirmed by tissue and/or cytological diagnosis.
- •There is no standard therapy, or even if available, the cancer was refractory to it or it was intolerable to the patient.
- •ECOG Performance Status of 0-1.
排除标准
- •Grade >=2 sensory neuropathy.
- •Use of any other therapeutic agents within 28 days prior to enrollment.
- •A history of drug hypersensitivity requiring systemic treatment, such as anaphylaxis, etc., or a history of hypersensitivity to carboplatin formulations or conventional paclitaxel formulations.
- •A complication of heart failure or ischemic heart disease (Class 2 or higher in the NYHA cardiac function classification), or a need for new treatment within 6 months before enrollment.
- •Use of a systemic antimicrobial to treat an infection within 14 days prior to enrollment.
- •Presence of pleural effusion, ascites or cardiac effusion for which drainage is considered necessary.
- •Presence of CNS metastasis accompanied by symptoms.
研究者
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