Open Label Study to Evaluate Safety and Efficacy of 2 Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed · Phase 2

Conditions studied: Leukemia, Myeloid, Acute

In brief

This study will evaluate two doses of Quizartinib in patients with relapsed or refractory acute myeloid leukemia who are also FMS-like tyrosine kinase - internal tandem duplication ( FLT3-ITD) positive. Patient will be randomly assigned in a 1:1 ratio to one of two treatment arms. Both treatment arms will receive Quizartinib but at different doses. The study treatment is taken orally in 28 day cycles until either disease progression occurs or an unacceptable toxicity occurs. In addition to the study assessments to evaluate the disease, blood will be drawn to measure drug levels and biomarkers. Patients will be followed for survival at three month intervals after the end of treatment.

Key facts

Study ID: NCT01565668
Run by: Daiichi Sankyo
People needed: 76
Starts: 2012-04-01
Expected to finish: 2015-03-01
Last updated by the study team: 2019-12-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject has morphologically documented primary acute myeloid leukemia (AML) or AML secondary to myelodysplastic syndrome (MDS) as defined by the World Health Organization (WHO) criteria, as determined by pathology review at the treating institution and has relapsed or is refractory after 1 second line (salvage) regimen or after hematopoietic stem cell transplantation (HSCT)
Subject is positive for FLT3-ITD activating mutation in bone marrow or peripheral blood (>10% allelic ratio)
Eastern Cooperative Oncology Group performance status of 0 to 2
In the absence of rapidly progressing disease clearly documented by the investigator, the interval from prior treatment to time of AC220 administration will be at least 2 weeks (14 days) for prior cytotoxic agents or at least 5 half-lives for prior noncytotoxic agents, including immunosuppressive therapy post HSCT
Persistent chronic clinically significant nonhematological toxicities from prior treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, HSCT, or surgery) must be Grade ≤ 1
Patients - both males and females - with reproductive potential are eligible

You may not qualify if…

Subject received previous treatment with AC220
Subject has a diagnosis of acute promyelocytic leukemia
Subject has a diagnosis of chronic myelogenous leukemia (CML) in blast crisis
Subject has AML or antecedent MDS secondary to prior chemotherapy
Subject has had HSCT and has either of the following:
Donor lymphocyte infusion (DLI) is not permitted during the study or < 30 days prior to study entry
Subject has clinically active central nervous system (CNS) leukemia. A subject is considered eligible if CNS leukemia is controlled and subject is receiving intrathecal (IT) therapy at study entry. Subjects should continue to receive IT therapy (or cranial radiation) as clinically indicated
Subject has received concurrent chemotherapy, immunotherapy, or radiotherapy within 14 days prior to the first dose of AC220, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation) within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
Subject requires treatment with concomitant drugs that prolong QT/QTc interval or with strong inhibitors or inducers of cytochrome P450- isozyme3A4 (CYP3A4) with the exception of antibiotics, antifungals, and antivirals that are used as standard of care post-transplant or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject
Subject requires treatment with anticoagulant therapy
Subject has a known positive test for human immunodeficiency virus, hepatitis C, or hepatitis B surface antigen
Subject had major surgery within 4 weeks prior to first dose of AC220
Subject has uncontrolled or significant cardiovascular disease, including
Subject has a pre-existing disorder predisposing the subject to a serious or life-threatening infection (e.g. cystic fibrosis, congenital or acquired immunodeficiency, bleeding disorder, or cytopenias not related to AML)
Subject has an active uncontrolled acute or chronic systemic fungal, bacterial, viral, or other infection
Subject has any of the following laboratory values:
Subject is a female with a positive pregnancy test, pregnant, or breastfeeding
Subject has any medical, psychiatric, addictive or other kind of disorder which compromises the ability of the subject to give written informed consent and/or to comply with procedures

Where it is running

UCLA School of Medicine — Los Angeles, California, United States
Northwestern University — Chicago, Illinois, United States
University of Chicago — Chicago, Illinois, United States
University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
John Hopkins University — Baltimore, Maryland, United States
Tufts University School of Medicine-Tufts Medical Center — Boston, Massachusetts, United States
University of Minnesota — Minneapolis, Minnesota, United States
Mayo Clinic — Rochester, Minnesota, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Weill Cornell Medical College — New York, New York, United States
Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Hollings Cancer Center — Charleston, South Carolina, United States
Vanderbilt University, Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States
UT Southwestern Medical Center, Simmons Cancer Center — Dallas, Texas, United States
MD Anderson — Houston, Texas, United States
Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
CHU d'Angers — Angers, France
CHU de Grenoble — Grenoble, France
Hôpital Saint Antoine — Paris, France
Hôpital Haut Lévêque — Pessac, France
Universitaria Policlinico S. Orsola Malpighi, Institute of Hemtology "L. & A. Seragnoli" — Bologna, Italy
Nottingham University Hospitals — Nottingham, England, United Kingdom

Full record on ClinicalTrials.gov

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