Study of Quizartinib in Combination With Standard Therapies in Chinese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

NCT03723681 | Completed Phase 1 DMC

• 1 other identifier: AC220-A-A103
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

20 mg or 40 mg of quizartinib will be given to Chinese patients who were just diagnosed with AML. The study drug will be given to them along with standard therapies. The purpose is to find out the highest dose they can stand.

Conditions

Acute Myeloid Leukemia (AML)

Outcome Measures

Primary Outcomes (5)

• Number of Participants with Dose-Limiting Toxicities

  At the end of induction phase at approximately 56 days

• Number of Participants with Adverse Events During the Trial

  within approximately 19 months

• Maximum Concentration (Cmax)

  Categories: quizartinib, active metabolite

  within 56 days

• Time to Cmax (Tmax)

  Categories: quizartinib, active metabolite

  within 56 days

• Area under the Plasma Concentration-Time Curve (AUC)

  Categories: quizartinib, active metabolite

  within 56 days

Secondary Outcomes (2)

• Number of Participants with Response

  within approximately 19 months

• Response Rates

  within approximately 19 months

Study Arms (2)

Quizartinib 20 mg

EXPERIMENTAL

Participants receive 20 mg quizartinib in combination with standard induction therapy and consolidation therapy once daily in the fasted state in the morning (at least 1 hour before or two hours after a meal)

Drug: Quizartinib

Quizartinib 40 mg

EXPERIMENTAL

Participants receive 40 mg quizartinib in combination with standard induction therapy and consolidation therapy once daily in the fasted state in the morning (at least 1 hour before or two hours after a meal)

Drug: Quizartinib

Interventions

Quizartinib DRUG

Quizartinib is provided as 20 mg tablets for oral administration

Also known as: Experimental product, AC220

Quizartinib 20 mg; Quizartinib 40 mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has provided written informed consent for participation in the study
• Is aged 18 to 70 years at the time of enrollment into the study
• Has newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm based on the World Health Organization (WHO) 2008 classification (at Screening)
• Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at enrollment
• Has all of the required laboratory test results performed within 14 days prior to enrollment in the study.
• Is capable of orally taking quizartinib
• Is capable of being admitted to the hospital during the dose limiting toxicity (DLT) evaluation period
• If a woman of childbearing potential, has a negative serum pregnancy test upon entry into this study and is willing to use highly effective birth control upon enrollment, during the treatment period and for 6 months following the last dose of investigational drug or cytarabine, whichever is later. A woman is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (having undergone a hysterectomy, bilateral salpingectomy or bilateral oophorectomy).
• If male, is surgically sterile or willing to use highly effective birth control upon enrollment, during the treatment period, and for 6 months following the last dose of investigational drug or cytarabine, whichever is later.

You may not qualify if:

• Has diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis). Subjects who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
• Has a diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms
• Had prior treatment for AML, except for the following allowances:
• Leukapheresis
• Treatment for hyperleukocytosis with hydroxyurea
• Cranial radiotherapy for central nervous system (CNS) leukostasis
• Prophylactic intrathecal chemotherapy
• Growth factor or cytokine support
• Has received prior treatment with any investigational product or device within 30 days prior to enrollment in the study or is currently participating in other investigational procedures
• Has a history of other malignancies excluding the following:
• Adequately treated non-melanoma skin cancer
• Curatively treated in situ disease, or other solid tumors curatively treated with no evidence of disease for at least two years
• Has a past or current history of the following cardiovascular diseases:
• Heart rate of \< 50 beats/min performed with 12-lead ECG within 14 days prior to enrollment in the study (excluding patients using a heart pacemaker)
• QT interval corrected by Fridericia (QTcF) of ≥ 450 msec performed with 12-lead ECG within 14 days prior to enrollment in the study

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, 300020, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

quizartinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 29, 2018
• Study Start: November 5, 2018
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

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

CN (1)