Refractory AML Clinical Trial
Official title:
A Phase 1, Open-Label, Dose Escalation Study of Quizartinib, An Oral FLT3 Inhibitor, in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia
Verified date | November 2018 |
Source | Daiichi Sankyo, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of quizartinib for Japanese acute myeloid leukemia (AML) subjects.
Status | Completed |
Enrollment | 17 |
Est. completion date | November 13, 2018 |
Est. primary completion date | November 13, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Relapsed or refractory AML - AML for which no standard treatment is available - ECOG Performance Status (PS) of 0 to 2 Exclusion Criteria: - Acute Promyelocytic Leukemia - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Daiichi Sankyo Co., Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of subjects experiencing adverse events | first dose to follow-up, approximately 1 year | ||
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | PIA assessment | Exploratory assessment of quizartinib-related biomarkers such as FLT3-ITD allelic ratio, PIA assessment. | Cycle 1: Days 1, 2, 8, 15 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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