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This is a dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of quizartinib for Japanese acute myeloid leukemia (AML) subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC220 | Experimental | This study will follow a mCRM (modified continual reassessment method) + EWOC (Escalation with Overdose Control) design. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC220 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of subjects experiencing adverse events | first dose to follow-up, approximately 1 year | |
| Cmax of quizartinib and its active metabolite | Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss. | Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15 |
| Tmax of quizartinib and its active metabolite | Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss. | Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15 |
| AUCtau of quizartinib and its active metabolite | Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss. | Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15 |
| Cmax,ss of quizartinib and its active metabolite | Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss. | Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15 |
| Ctrough of quizartinib and its active metabolite | Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss. | Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15 |
| Measure | Description | Time Frame |
|---|---|---|
| FMS-like tyrosine kinase-3 / internal tandem duplication FLT3/ITD allelic ratio | Exploratory assessment of quizartinib-related biomarkers such as FLT3-ITD allelic ratio, PIA assessment. | Cycle 1: Days 1, 2, 8, 15 |
| PIA assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31359361 | Derived | 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. |
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De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
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| Tmax,ss of quizartinib and its active metabolite | Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss. | Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15 |
| AUCtau,ss of quizartinib and its active metabolite | Evaluate the pharmacokinetics of quizartinib and its active metabolite, AC886 by Cmax, Tmax, AUCtau, Cmax,ss, Ctrough, Tmax,ss, AUCtau,ss. | Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15 |
Exploratory assessment of quizartinib-related biomarkers such as FLT3-ITD allelic ratio, PIA assessment.
| Cycle 1: Days 1, 2, 8, 15 |
| bone marrow findings | Exploratory analyses of tumor response to quizartinib based on bone marrow findings, absolute neutrophil count, and platelet count. | Cycle 1: Days 15, 28; Cycle 2 and on: Day 28 |
| absolute neutrophil count | Exploratory analyses of tumor response to quizartinib based on bone marrow findings, absolute neutrophil count, and platelet count. | Cycle 1: Days 15, 28; Cycle 2 and on: Day 28 |
| platelet count | Exploratory analyses of tumor response to quizartinib based on bone marrow findings, absolute neutrophil count, and platelet count. | Cycle 1: Days 15, 28; Cycle 2 and on: Day 28 |
| D006425 |
| Hemic and Lymphatic Diseases |