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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03603964
Registration number
NCT03603964
Ethics application status
Date submitted
19/07/2018
Date registered
27/07/2018
Date last updated
26/04/2023
Titles & IDs
Public title
Guadecitabine Extension Study
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Scientific title
An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Guadecitabine Clinical Studies
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Secondary ID [1]
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SGI-110-12
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia
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Myeloid Dysplastic Syndrome
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Guadecitabine
Experimental: 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.
Treatment: Drugs: Guadecitabine
Guadecitabine
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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Assessment method [1]
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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.
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Timepoint [1]
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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.
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Secondary outcome [1]
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Overall Survival
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Assessment method [1]
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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).
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Timepoint [1]
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From randomization in the prior study to the date of death
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Eligibility
Key inclusion criteria
1. 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.
2. Participant is considered to be benefitting from guadecitabine treatment in the
opinion of the treating investigator.
3. 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 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/07/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/10/2021
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Sample size
Target
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Accrual to date
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Final
35
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New York
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United States of America
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State/province [2]
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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Austria
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Styria
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Canada
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Ontario
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Denmark
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Copenhagen
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Italy
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Alessandria
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Italy
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Genova
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Italy
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Milano
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Italy
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Udine
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Japan
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Isehara-shi
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Japan
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Kyoto-shi
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Japan
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State/province [15]
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Saga-shi
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Korea, Republic of
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State/province [16]
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Seoul
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Korea, Republic of
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Ulsan
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Spain
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Madrid
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Country [19]
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Taiwan
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State/province [19]
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Astex Pharmaceuticals, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
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)].
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03603964
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03603964
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