- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03603964
Guadecitabine Extension Study
An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Guadecitabine Clinical Studies
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Styria
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Graz, Styria, Austria
- Medizinische Universität Graz
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital - General
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Cancer Center
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Copenhagen, Denmark
- Rigshospitalet-Copenhagen University Hospital
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Alessandria, Italy
- Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
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Genova, Italy
- Azienda Ospedaliera Universitaria San Martino
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Milano, Italy
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
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Udine, Italy
- Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine
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Isehara-shi, Japan, 259-1193
- Tokai University Hospital
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Kyoto-shi, Japan, 602-8026
- Japanese Red Cross Kyoto Daini Hospital
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Saga-shi, Japan, 849-8501
- Saga University Hospital
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Seoul, Korea, Republic of, 03722
- Severance Hospital, Yonsei University Health System
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Ulsan, Korea, Republic of, 44033
- Ulsan University Hospital
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Madrid, Spain
- Hospital Universitario 12 de Octubre
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Taipei, Taiwan
- Mackay Memorial Hospital
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Taipei, Taiwan
- National Taiwan University Hospital
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New York
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Buffalo, New York, United States, 14263
- Roswell Park
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke Cancer Center
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Temple University
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Tennessee
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Nashville, Tennessee, United States, 37203
- Center for Blood Cancers
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Guadecitabine
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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.
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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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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 Measures
Outcome Measure |
Measure Description |
Time Frame |
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Overall Survival
Time Frame: From randomization in the prior study to the date of death
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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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From randomization in the prior study to the date of death
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SGI-110-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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