Phase 1 Study of Quizartinib

NCT02675478 | Completed Phase 1 FDA Drug

• 1 other identifier: AC220-A-J101
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapsed AML; Refractory AML

Keywords

AML; phase 1; oncology

Outcome Measures

Primary Outcomes (8)

• 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

• 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

Secondary Outcomes (5)

• FMS-like tyrosine kinase-3 / internal tandem duplication FLT3/ITD allelic ratio

  Cycle 1: Days 1, 2, 8, 15

• PIA assessment

  Cycle 1: Days 1, 2, 8, 15

• bone marrow findings

  Cycle 1: Days 15, 28; Cycle 2 and on: Day 28

• absolute neutrophil count

  Cycle 1: Days 15, 28; Cycle 2 and on: Day 28

• platelet count

  Cycle 1: Days 15, 28; Cycle 2 and on: Day 28

Study Arms (1)

AC220

EXPERIMENTAL

This study will follow a mCRM (modified continual reassessment method) + EWOC (Escalation with Overdose Control) design.

Drug: AC220

Interventions

AC220 DRUG

AC220

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Relapsed or refractory AML
• AML for which no standard treatment is available
• ECOG Performance Status (PS) of 0 to 2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 31359361 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 5, 2016
• Study Start: February 1, 2016
• Primary Completion: November 13, 2018
• Study Completion: November 13, 2018
• Last Updated: February 12, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 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.
• Access Criteria: 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.

Locations

JP (1)