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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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2016-02-29
2018-11-13
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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AC220
This study will follow a mCRM (modified continual reassessment method) + EWOC (Escalation with Overdose Control) design.
AC220
Interventions
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AC220
Eligibility Criteria
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Inclusion Criteria
* AML for which no standard treatment is available
* ECOG Performance Status (PS) of 0 to 2
Exclusion Criteria
* chronic myelogenous leukemia in blast phase (BCR-ABL fusion gene positive)
* History of other malignancies within 3 years prior to enrollment, except curatively treated in-situ carcinoma, AML, or MDS.
20 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Tokyo, , Japan
Countries
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References
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Usuki K, Handa H, Choi I, Yamauchi T, Iida H, Hata T, Ohwada S, Okudaira N, Nakamura K, Sakajiri S. Safety and pharmacokinetics of quizartinib in Japanese patients with relapsed or refractory acute myeloid leukemia in a phase 1 study. Int J Hematol. 2019 Dec;110(6):654-664. doi: 10.1007/s12185-019-02709-8. Epub 2019 Jul 29.
Other Identifiers
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AC220-A-J101
Identifier Type: -
Identifier Source: org_study_id
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