EUCTR2017-004603-52-FI进行中（未招募）1 期
An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Guadecitabine Clinical Studies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
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
- •Subjects must fulfill all of the following inclusion criteria:
- •1. Previous participation in an Astex-sponsored guadecitabine clinical trial (including but not limited to SGI-110-01, SGI-110-04, SGI-110-05, SGI-110-06, and SGI-110-07), in which the subject was treated with
- •guadecitabine and was still on active treatment with guadecitabine at the time of database close for the prior study.
- •2. Subject is considered to be benefitting from guadecitabine treatment in the opinion of the treating investigator.
- •3. Subject is able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before any study-specific procedure.
- •4. Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group[CTFG]; see protocol Section 5.2 for details) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of childbearing potential and men with female partners of childbearing potential must agree to practice 2 highly effective contraceptive measures of birth control (as described in Section 5.2) and must agree not to become pregnant or father a child while receiving guadecitabine and for at
- •least 3 months after completing guadecitabine 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 1
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 249
排除标准
- •Subjects meeting any of the following exclusion criteria will be excluded from the study:
- •1. Any subject who, in the opinion of the investigator, may have other conditions, organ dysfunction, or have safety data from their prior study participation that suggest that the risks of continuing treatment with guadecitabine may outweigh the benefits
研究者
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