EUCTR2018-003942-18-ES进行中（未招募）1 期
An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Previous participation in an Astex-sponsored ASTX727 clinical trial (including but not limited to studies ASTX727-01, ASTX727-02, ASTX727-04, ASTX727-17, ASTX727-18) in which the subject was treated with ASTX727 and was still on active treatment with ASTX727 at the time of study completion as determined by Astex.
- •2) Subject is considered to be benefitting from ASTX727 treatment in the opinion of the treating investigator at the time of parent study completion. (Subjects must not be withdrawn from the parent study until eligibility for this study is confirmed.)
- •3) Subject is able to understand and comply with the study procedures and understands the risks involved in the study.
- •4) Subject provides legally effective informed consent before undergoing any study-specific procedure.
- •5) Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group [CTFG]) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential must agree to practice 1 highly effective contraceptive measure of birth control with low user dependency and must agree not to become pregnant for 6 months after completing treatment.
- •6) Men with female partners of childbearing potential must agree to use a male condom and advise his partner to practice 1 highly effective contraceptive measure (user dependent or with low user dependency) while receiving treatment with ASTX727 for at least 3 months after completing treatment and must agree not to father a child while receiving study treatment for at least 3 months after completing ASTX727 treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •1) Any subject who, in the opinion of the investigator, may have other conditions or for whom safety data from parent study participation suggests the risks of continuing treatment with ASTX727 may outweigh the benefits.
研究者
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