Clinical trial NCT01555268 (phase 1, status: completed)
Conditions: adult acute megakaryoblastic leukemia (m7), adult acute minimally differentiated myeloid leukemia (m0), adult acute monoblastic leukemia (m5a), adult acute monocytic leukemia (m5b), adult acute myeloblastic leukemia with maturation (m2), adult acute myeloblastic leukemia without maturation (m1), adult acute myeloid leukemia with 11q23 (mll) abnormalities, adult acute myeloid leukemia with del(5q), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myelomonocytic leukemia (m4), adult erythroleukemia (m6a), adult pure erythroid leukemia (m6b), recurrent adult acute myeloid leukemia, untreated adult acute myeloid leukemia
ICD codes: C94.21, C94.22, C94.20, C7A.1, C93.01, C93.02, C93.00, C93.Z1, C93.Z2, C93.91, C93.92, C93.01, C93.02, C93.Z0, C92.01, C92.02, C92.00, C92.01, C92.02, C92.00, R19.5, H35.09, M26.50, M26.59, Q99.8, R06.89, R06.9, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, C92.51, C92.52, C93.11, C93.12, C93.31, C93.32, C92.50, C94.01, C94.02, C94.00, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: cytarabine
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of AML as defined by the World Health Organization (excluding acute
             promyelocytic leukemia and chronic myeloid leukemia- blast/accelerated phase) in an
             adult patient

               -  Patients with newly diagnosed untreated AML for whom the treatment of choice is
                  low-intensity therapy by investigator assessment or who has declined intensive
                  induction therapy recommended by the investigator OR

               -  Patients with refractory or relapsed AML following at least one prior treatment
                  course who are not currently considered eligible for stem cell transplantation at
                  the time of screening due to non-optimal AML disease control, lack of suitable
                  transplantation donor, failure to meet other transplantation criteria, or refusal
                  to undergo transplantation

          -  Eastern Cooperative Oncology Group (ECOG) status 0-2 (ECOG 3 is excluded)

          -  Total bilirubin within normal institutional limits

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and
             alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x
             institutional upper limit of normal (ULN)

          -  Creatinine clearance > 40ml/min per 24 hour urine collection or calculated according
             to the Cockcroft-Gault formula

          -  Urinary protein quantitative value of less than 30mg/dL in urine analysis or less than
             1+ on dipstick, unless quantitative protein is < 1000mg in a 24 hour urine sample

          -  Partial thromboplastin time (PTT) or activated (aPTT) =< 1.5 x ULN per institution
             laboratory range and international normalized ratio (INR) =< 1.5

          -  Patient or legal representative must understand the investigational nature of this
             study and sign an Independent Ethics Committee/Institutional Review Board approved
             written informed consent form prior to receiving any study related procedure

          -  Individuals of childbearing potential must agree to use acceptable contraceptive
             methods (e.g., double barrier) during treatment

        Exclusion Criteria:

          -  History of central nervous system involvement with leukemia

          -  History of venous or arterial thromboembolism within 12 months prior to enrollment

          -  History of clinically significant bleeding within 6 months of enrollment

          -  Unresolved toxicities from prior systemic therapies that are Common Terminology
             Criteria for Adverse Events (CTCAE) version 4 >= Grade 2 in severity except alopecia
             excluding hematological toxicities attributable to underlying disease

          -  Currently or previously treated with AMG 386, or other molecules that inhibit the
             angiopoietins or Tie2 receptor

          -  Current or within 30 days prior to enrollment treatment with immune modulators such as
             systemic cyclosporine or tacrolimus

          -  Has not yet completed a 14 day washout period for any previous anti-cancer systemic
             therapies (30 days for prior bevacizumab) with the exception of hydroxyurea or
             leukapheresis for uncontrolled leukocytosis

          -  Enrolled in or has not yet completed at least 14 days since ending other
             investigational device or drug trials, or currently receiving other investigational
             treatments

          -  Clinically significant cardiovascular disease within 12 months prior to enrollment,
             including myocardial infarction, unstable angina, grade 2 or greater peripheral
             vascular disease, cerebrovascular accident, transient ischemic attack, congestive
             heart failure, or arrhythmias not controlled by outpatient medication or placement of
             percutaneous transluminal coronary angioplasty/stent

          -  Major surgery within 28 days prior to enrollment or still recovering from prior
             surgery

          -  Minor surgical procedures, placement of tunneled central venous access device within 3
             days prior to enrollment

          -  Uncontrolled hypertension as defined as diastolic > 90mmHg OR systolic > 140mmHg; the
             use of anti-hypertensive medication to control hypertension is permitted

          -  Non-healing wound, ulcer (including gastrointestinal) or fracture

          -  Active uncontrolled infection, including human immunodeficiency virus (HIV) and active
             hepatitis infection

          -  Subject not consenting to the use of highly effective contraceptive, e.g., double
             barrier method (i.e., condom plus diaphragm) precautions during the course of the
             study and for 6 months after administration of the last study medication

          -  Subject has known sensitivity to any of the products to be administered during dosing

          -  History of allergic reactions to bacterially produced proteins

          -  Subject has previously been enrolled onto this study

          -  Subject will not be available for follow-up assessment

          -  Pregnant or nursing female patients

          -  Active second malignancy other than AML which is not in remission and/or for which the
             patient is currently receiving treatment

          -  Subject has any kind of disorder that compromises the ability of the subject to give
             written informed consent and/or to comply with study procedures

          -  Any condition which in the investigator's opinion makes the patient an unsuitable
             candidate for study participation