Phase 1 Study of Quizartinib

NCT ID: NCT02675478

Last Updated: 2019-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-11-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Relapsed AML Refractory AML

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AC220

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

Group Type EXPERIMENTAL

AC220

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AC220

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tokyo, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31359361 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AC220-A-J101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.