Guadecitabine Extension Study

Study 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.

Official Title
-----------------
An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Guadecitabine Clinical Studies

Conditions
-----------------
Acute Myeloid Leukemia, Myeloid Dysplastic Syndrome

Intervention / Treatment
-----------------
* Drug: Guadecitabine


Participation Criteria
=================
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: 1. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guadecitabine<br>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. | Drug: Guadecitabine<br>* Guadecitabine<br>* Other names: SGI-110;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival was defined as the number of days from the time of randomization in the prior study to the date of death (regardless of cause). Participants without a documented death date at the time of analysis were censored at the last date known alive. Survival time in days = (earliest of date of death or censoring) - (randomization date in the prior study). | From randomization in the prior study to the date of death | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Guadecitabine