An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Guadecitabine Clinical Studies
Description
Brief Summary
This is a multicenter, open-label extension study for participants who participated in a
previous Astex-sponsored guadecitabine clinical study [including but not limited to
SGI-110-01 (NCT01261312), SGI-110-04 (NCT02348489), SGI-110-06 (NCT02920008), and SGI-110-07
(NCT02907359)].
Detailed Description
Participants who were still receiving treatment with guadecitabine and in the opinion of the
investigator were still benefitting from treatment at the time of database close of the
original study will be eligible to participate in this extension study. Approximately 250
subjects could be enrolled.
Participants will attend clinic visits on Days 1-5 of each 28-day cycle to receive treatment
with guadecitabine. Data collection will be limited to treatment exposure, adverse events,
concomitant medications, limited laboratory parameters, and survival status.
Phase
N/AInclusion and Exclusion Criteria
- Previous participation in an Astex-sponsored guadecitabine clinical trial [including but not limited to SGI-110-01 (NCT01261312), SGI-110-04 (NCT03603964), SGI-110-05, SGI-110-06 (NCT02920008), and SGI-110-07 (NCT02907359)], in which the participant was treated with guadecitabine and was still on active treatment with guadecitabine at the time of database close for the prior study.
- Participant is considered to be benefitting from guadecitabine treatment in the opinion of the treating investigator.
- 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 child-bearing 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 and men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures while receiving treatment with guadecitabine and for at least 3 months after completing treatment and must agree not to become pregnant or father a child while receiving study treatment and for at least 3 months after completing guadecitabine treatment.
- Any participant 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.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.