A clinical study to provide ongoing treatment with guadecitabine to subjects who were benefitting from guadecitabine treatment in a previous clinical study.
- Conditions
- Acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and chronic myelomonocytic leukemia (CMML)MedDRA version: 20.0Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10009018Term: Chronic myelomonocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-004603-52-HU
- Lead Sponsor
- Astex Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method