Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
35 participants
INTERVENTIONAL
2018-07-18
2021-10-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Guadecitabine
Guadecitabine
Interventions
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Guadecitabine
Guadecitabine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Astex Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Roswell Park
Buffalo, New York, United States
Duke Cancer Center
Durham, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Temple University
Philadelphia, Pennsylvania, United States
Center for Blood Cancers
Nashville, Tennessee, United States
Medizinische Universität Graz
Graz, Styria, Austria
The Ottawa Hospital - General
Ottawa, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Rigshospitalet-Copenhagen University Hospital
Copenhagen, , Denmark
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
Alessandria, , Italy
Azienda Ospedaliera Universitaria San Martino
Genova, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine
Udine, , Italy
Tokai University Hospital
Isehara-shi, , Japan
Japanese Red Cross Kyoto Daini Hospital
Kyoto, , Japan
Saga University Hospital
Saga, , Japan
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Hospital Universitario 12 de Octubre
Madrid, , Spain
Mackay Memorial Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SGI-110-12
Identifier Type: -
Identifier Source: org_study_id
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