Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
73 participants
INTERVENTIONAL
2015-04-30
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Radotinib
Radotinib treatement single arm
Radotinib
Radotinib 400mg bid
Interventions
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Radotinib
Radotinib 400mg bid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG 0, 1, 2
* Patients who are agree and signed to informed consent.
Exclusion Criteria
* Prior exposure to radotinib
* Accelerated or blastic phase
* galactose intolerance, severe lactase deficiency or glucose galactose malabsorption
* Prior history of intensive cytotoxic chemotherapy except for TKIs
* Significant cardiac problem
* QTcF \> 450 msec
* Pancreatitis history prior to study enrollment
* Clinically significant malignant disease other than CML
* Pregnant or breast feeding woman
18 Years
ALL
No
Sponsors
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Ulsan University Hospital
OTHER
Responsible Party
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Hawk Kim
Associate Professor
Principal Investigators
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Hawk Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Ulsan University Hospital
Locations
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Ulsan University Hospital
Ulsan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RAD-201501
Identifier Type: -
Identifier Source: org_study_id
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