An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Guadecitabine Clinical Studies
Overview
- Phase
- Phase 2
- Intervention
- Guadecitabine
- Conditions
- Acute Myeloid Leukemia
- Sponsor
- Astex Pharmaceuticals, Inc.
- Enrollment
- 35
- Locations
- 21
- Primary Endpoint
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion 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.
Exclusion Criteria
- •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.
Arms & Interventions
Guadecitabine
Participants received guadecitabine, subcutaneous (SC) injection on Days 1-5 of each 28-day cycle at the same dose that they were receiving in the last cycle of their prior study or at a different dose as guided by the dose adjustment guidelines in the prior study protocol.
Intervention: Guadecitabine
Outcomes
Primary Outcomes
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: From the start of study treatment until 30 days after the last dose of study treatment or prior to the participant receiving alternative anticancer therapy, whichever occurs first.
Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including a clinically significant abnormal finding in laboratory tests or other diagnostic procedures), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAEs are defined as events that occur or worsen on or after the date of the first study treatment (Cycle 1 Day 1 {C1D1}) until 30 days after the last dose of study treatment or the start of an alternative anti-cancer treatment, whichever occurs first.
Secondary Outcomes
- Overall Survival(From randomization in the prior study to the date of death)