Clinical trial NCT02675478: Phase 1 Study of Quizartinib
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Relapsed AML
Refractory AML
Keywords: AML
phase 1
oncology
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2016-02-05
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of quizartinib for Japanese acute myeloid leukemia (AML) subjects.


Eligibility criteria: 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.

Primary outcomes:
measure: number of subjects experiencing adverse events
timeFrame: first dose to follow-up, approximately 1 year
measure: Cmax of quizartinib and its active metabolite
timeFrame: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
measure: Tmax of quizartinib and its active metabolite
timeFrame: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
measure: AUCtau of quizartinib and its active metabolite
timeFrame: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
measure: Cmax,ss of quizartinib and its active metabolite
timeFrame: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
measure: Ctrough of quizartinib and its active metabolite
timeFrame: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
measure: Tmax,ss of quizartinib and its active metabolite
timeFrame: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
measure: AUCtau,ss of quizartinib and its active metabolite
timeFrame: Cycle 1: Days 1, 2, 4, 8, 11, 15, 16, 18, 22, 28; Cycle 2 and on: Days 1, 15
Secondary outcomes:
measure: FMS-like tyrosine kinase-3 / internal tandem duplication FLT3/ITD allelic ratio
timeFrame: Cycle 1: Days 1, 2, 8, 15
measure: PIA assessment
timeFrame: Cycle 1: Days 1, 2, 8, 15
measure: bone marrow findings
timeFrame: Cycle 1: Days 15, 28; Cycle 2 and on: Day 28
measure: absolute neutrophil count
timeFrame: Cycle 1: Days 15, 28; Cycle 2 and on: Day 28
measure: platelet count
timeFrame: Cycle 1: Days 15, 28; Cycle 2 and on: Day 28
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
References:
citation: 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.