Acute Myeloid Leukemia(AML), Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML)
Conditions
Interventions
investigational material(s)
Generic name etc : SGI-110
INN of investigational material : 429
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational materi
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Astex Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Safety as measured by adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| safety Survival status which will be documented at the time of withdrawal from the study. | — |
Countries
Europe, Japan, North America
Outcome results
None listed