An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Guadecitabine Clinical Studies
- Conditions
- Acute Myeloid Leukemia(AML), Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML)
- Registration Number
- JPRN-jRCT2080223957
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 250
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.
- Subject is considered to be benefitting from guadecitabine treatment in the opinion of the treating investigator.
- 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.
- 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 childbearing potential and men with female partners of childbearing potential must agree to practice 2 highly effective contraceptive measures of birth control and must agree not to become pregnant or father a child while receiving guadecitabine and for at least 3 months after completing guadecitabine treatment.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Safety as measured by adverse events
- Secondary Outcome Measures
Name Time Method safety<br>Survival status which will be documented at the time of withdrawal from the study.