jRCT2080224127已完成1 期
A Study to Evaluate CTX-712 in Advanced, Relapsed or Refractory Malignant Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Phase 1, Open-label, Non-controlled, Multi-center, Repeat dose, Dose escalation study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit(—)
- 性别
- All
入选标准
- •Subjects must have an advanced, relapsed or refractory cancer
- •For a cohort of hematological cancers,subjects must have an MDS, CMML or AML (excluding APL) according to World Health Organization (WHO) criteria.
- •As for MDS, subjects must be considered an intermediate, high, or very high risk according to the Revised International Prognostic Scoring System (IPSS-R)
- •Subjects must relapse or refractory to standard therapies, or not eligible for standard therapies.
- •Subjects must be an eastern cooperative oncology group (ECOG) performance status of 0 or 1
- •Subjects must have more than 90 days life expectancy
- •Subjects must have adequate major organ functions
排除标准
- •Patients with uncontrolled complications
- •Patients with active multiple primary cancers that require specific treatments
- •In a cohort of hematologic cancer patients, those who have received allogenic hematopoietic stem cell transplantation
- •Patients having a medical history of congenital retinal degenerative disease,optic nerve or retinal diseases
结局指标
主要结局
-
safety efficacy Maximum Tolerated Dose (MTD) and Dose-Limiting Toxicity (DLT)
次要结局
未报告次要终点
研究者
研究点 (1)
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