Clinical trial NCT02181660 (phase 1, status: completed)
Conditions: acute myeloid leukemia (aml)
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: gilteritinib
SMILES: CCC1=C(NC2CCOCC2)N=C(NC2=CC=C(N3CCC(CC3)N3CCN(C)CC3)C(OC)=C2)C(=N1)C(N)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Subject is defined as morphologically documented primary or secondary acute myeloid
             leukemia (AML) according to the World Health Organization (WHO) criteria (2008) and
             fulfills one of the following:

               -  Refractory to prior induction chemotherapy

               -  Relapsed after achieving remission with prior therapy

          -  Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

          -  Subject's interval from prior treatment to the time of study drug administration is at
             least 14 days for antineoplastic agents other than ASP2215 (except for hydroxyurea,
             which is given to control blast cells).

          -  Subject's interval from prior treatment to the time of study drug (ASP2215)
             administration is at least 5 half-lives (if the half-life is unknown, 14 days) for
             other investigational products or drugs used for immunosuppressive therapy
             posthematopoietic stem cell transplantation (HSCT).

        Exclusion Criteria:

          -  Subject was diagnosed with acute promyelocytic leukemia (APL).

          -  Subject has breakpoint cluster region-abelson (BCR-ABL)-positive leukemia (chronic
             myelogenous leukemia in blast crisis)

          -  Subject has active malignant tumors other than AML or myelodysplastic syndrome (MDS)

          -  Subject has persistent non-hematological toxicities of ≥ Grade 2 (CTCAE v4), with
             symptoms and objective findings, due to prior AML treatment (including chemotherapy,
             kinase inhibitors, immunotherapy, investigational products, radiation therapy, and
             surgery)

          -  Subject has received hematopoietic stem cell transplant (HSCT) and falls under either
             of the following:

               -  Is within 2 months of transplant

               -  Has persistent and clinically significant graft-versus-host disease requiring
                  treatment

               -  Has persistent non-hematological toxicities of ≥ Grade 2 related to the
                  transplant

          -  Subject has clinically active central nervous system leukemia

          -  Subject has disseminated intravascular coagulation (DIC)

          -  Subject has had major surgery within 28 days prior to the first study drug
             administration

          -  Subject has had radiation therapy within 28 days prior to the first study drug
             administration

          -  Subject has congestive heart failure of NYHA class 3 or 4, or subject with a past
             history of congestive heart failure of NYHA class 3 or 4 and in whom echocardiogram or
             Multiple Gate Acquisition (MUGA) scan performed within 3 months prior to screening or
             at screening showed a left ventricular ejection fraction (LVEF) of < 45%.

          -  Subject requires treatment with concomitant drugs that are strong inhibitors or
             inducers of CYP3A4 or of P-gp with such exceptions of antibiotics, antifungals, and
             antivirals that are considered absolutely essential for prevention or treatment of
             infections and for which the physician judged that there are no interchangeable drugs.

          -  Subject requires treatment with concomitant drugs that target serotonin 5HT1R or
             5HT2BR receptors or sigma nonspecific receptors, with the exception of drugs that are
             considered absolutely essential for treatment of the subject.

          -  Subject has an active uncontrollable infection

          -  Subject is known to have human immunodeficiency virus (HIV) infection

          -  Subject has active hepatitis B or C or other active hepatic disorders