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Trial record 1 of 1 for:    QuANTUM-First
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Quizartinib With Standard of Care Chemotherapy and as Maintenance Therapy in Patients With Newly Diagnosed FLT3-ITD (+) AML (QuANTUM-First)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Daiichi Sankyo Inc.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT02668653
First received: January 22, 2016
Last updated: October 18, 2016
Last verified: October 2016
  Purpose
This is a phase 3, randomized, double-blind, placebo-control global study. The purpose of this study is to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 12 cycles) on event-free survival in subjects with FLT3-ITD positive AML.

Condition Intervention Phase
Acute Myeloid Leukemia
Leukemia
Drug: Cytarabine
Drug: Daunorubicin
Drug: Idarubicin
Drug: Quizartinib
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib (AC220) Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Maintenance Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Event-free Survival (EFS) [ Time Frame: Duration of study, an average of 2 years ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Duration of study, an average 2 years ]
  • Complete remission (CR) rate at the end of the first Induction cycle [ Time Frame: Approximately 42 days ]
  • Composite CR rate at the end of the first Induction cycle [ Time Frame: Approximately 42 days ]
  • Percentage of subjects achieving CR with no evidence of minimal residual disease [ Time Frame: Approximately 42 days ]

Estimated Enrollment: 536
Study Start Date: September 2016
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Induction and consolidation chemotherapy plus quizartinib

Induction: up to 2 cycles with cytarabine and daunorubicin/idarubicin, followed by the experimental drug quizartinib

Consolidation: up to 4 cycles of cytarabine followed by the experimental drug quizartinib and/or hematopoeitic stem cell transplant

Maintenance: up to 12 cycles with the experimental drug quizartinib

Drug: Cytarabine Drug: Daunorubicin Drug: Idarubicin Drug: Quizartinib
Active Comparator: Induction and consolidation chemotherapy plus placebo

Induction: up to 2 cycles with cytarabine and daunorubicin/idarubicin, followed by placebo

Consolidation: up to 4 cycles of cytarabine followed by placebo and/or hematopoeitic stem cell transplant

Maintenance: up to 12 cycles with placebo

Drug: Cytarabine Drug: Daunorubicin Drug: Idarubicin Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be competent and able to comprehend, sign, and date an Ethics Committee (EC) or Institutional Review Board approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests;
  2. ≥18 years or the minimum legal adult age (whichever is greater) and ≤75 years (at Screening);
  3. Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome, based on the World Health Organization (WHO) 2008 classification (at Screening);
  4. Eastern Cooperative Oncology Group performance status 0-2 (at Screening);
  5. Presence of FLT3-ITD activating mutation in bone marrow (allelic ratio of ≥3% FLT3-ITD/total FLT3);
  6. Subject is receiving standard "7+3" induction chemotherapy regimen as specified in the protocol;
  7. Adequate renal function defined as:

    • Serum creatinine ≤1.5 × the upper limit of normal (ULN); or
    • Glomerular filtration rate >50 mL/min/1.73m2, as calculated with the modified Cockcroft Gault equation;
  8. Adequate hepatic function defined as:

    • Total serum bilirubin ≤1.5 × ULN;
    • Serum alkaline phosphatase, aspartate transaminase and alanine transaminase ≤2.5 × ULN;
  9. Serum electrolytes (potassium, calcium, and magnesium) within normal limits. If outside of normal limits, subject will be eligible when electrolytes are corrected;
  10. If female, must be either postmenopausal (no menstrual period for a minimum of 12 months), surgically sterile, or if of childbearing potential, must have a negative serum pregnancy test upon entry into this study and must be willing to use maximally effective double-barrier birth control during the period of therapy and contraception for 3 months following the last investigational drug dose;
  11. If male, must be surgically sterile or willing to use an effective double-barrier contraception method upon enrollment, during the course of the study, and for 3 months following the last investigational drug dose.

Exclusion Criteria:

  1. 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);
  2. Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms;
  3. 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/cytokine support;
  4. Prior treatment with quizartinib or other FLT3-ITD inhibitors;
  5. Prior treatment with any investigational drug or device within 30 days prior to Randomization or who are currently participating in other investigational procedures;
  6. History of known CNS leukemia, including cerebrospinal fluid positive for AML blasts; lumbar puncture is recommended for subjects with symptoms of CNS leukemia to rule out extramedullary CNS involvement;
  7. History of other malignancies, except 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 2 years;
  8. Uncontrolled or significant cardiovascular disease, including any of the following:

    • Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker;
    • QTcF interval >450 msec;
    • Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
    • Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg;
    • History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);
    • History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);
    • History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;
    • History of New York Heart Association Class 3 or 4 heart failure;
    • Known history of left ventricular ejection fraction (LVEF) ≤45% or less than the institutional lower limit of normal;
    • History of complete left or complete right bundle branch block;
  9. Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;
  10. Known active clinically relevant liver disease (eg, active hepatitis B, or active hepatitis C)
  11. Known history of human immunodeficiency virus (HIV). Subjects should be tested for HIV prior to randomization if required by local regulations or EC;
  12. History of hypersensitivity to any excipients in the quizartinib/placebo tablets;
  13. Females who are pregnant or breastfeeding;
  14. Otherwise considered inappropriate for the study by the investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02668653

Contacts
Contact: James J. Hanyok, PharmD 732-590-4881 jhanyok@dsi.com

Locations
United States, Arizona
Univ. of Arizona Cancer Center - North Campus Recruiting
Tucson, Arizona, United States, 85724
United States, California
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
United States, Florida
Univ. Florida Health Shands Cancer Hospital Recruiting
Gainesville, Florida, United States, 32610
United States, Illinois
Rush Univ. Medical Center Recruiting
Chicago, Illinois, United States, 60612
Univ. of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
Franciscan St. Francis Health Recruiting
Indianapolis, Indiana, United States, 46237
United States, New Jersey
Hackensack Univ. Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
United States, Oklahoma
Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Thomas Jefferson Univ. Recruiting
Philadelphia, Pennsylvania, United States, 19107
Canada, Ontario
Univ. Health Network - Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Hungary
Recruiting
Budapest, Hungary, 7624
Recruiting
Debrecen, Hungary, 4032
Recruiting
Szombathely, Hungary, 9700
Sponsors and Collaborators
Daiichi Sankyo Inc.
Investigators
Study Director: James J. Hanyok, PharmD Daiichi Sankyo Inc.
  More Information

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT02668653     History of Changes
Other Study ID Numbers: AC220-A-U302
2015-004856-24 ( EudraCT Number )
Study First Received: January 22, 2016
Last Updated: October 18, 2016

Keywords provided by Daiichi Sankyo Inc.:
Newly diagnosed Acute Myeloid Leukemia
FLT3-ITD positive
Chemotherapy
Induction chemotherapy
Consolidation chemotherapy
Maintenance chemotherapy
Quizartinib
Receptor tyrosine kinase inhibitor
FMS-like tyrosine kinase 3
AC220
FLT3-ITD
AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Daunorubicin
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 25, 2017