Clinical trial NCT00642031 (phase 1, status: completed)
Conditions: hematologic malignancies, leukemia
ICD codes: E70.338, E70.339, P09.3, O28.0, P61.8, P61.9, T45.8X1A, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: triciribine
SMILES: [H][C@]1(CO)O[C@@]([H])(N2C=C3C4=C(N=CN=C24)N(C)NC3=N)[C@]([H])(O)[C@]1([H])O
Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have relapsed/refractory leukemias for which no standard therapies are
             anticipated to result in a durable remission. Patients with poor-risk myelodysplasia
             (MDS) [i.e. refractory anemia with excess blasts (RAEB-1 or RAEB-2) by WHO
             classification] and chronic myelomonocytic leukemia (CMML) are also candidates for
             this protocol.

          2. CONTINUATION # 1: Relapsed/refractory leukemias include acute non-lymphocytic leukemia
             (AML) by World Health Organization (WHO) classification, acute lymphocytic leukemia
             (ALL), chronic lymphocytic leukemia (CLL), or chronic myelogenous leukemia (CML) in
             blast crisis. Patients with agnogenic myeloid metaplasia (AMM) are also eligible;

          3. ECOG performance status of 0- 3;

          4. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically
             sterile) must use acceptable contraceptive methods (abstinence, intrauterine device
             [IUD], oral contraceptive or double barrier device), and must have a negative serum or
             urine pregnancy test within 2 weeks prior to beginning treatment on this trial.
             Nursing patients are excluded. Sexually active men must also use acceptable
             contraceptive methods for the duration of time on study. Pregnant and nursing patients
             are excluded because the effects of Triciribine on a fetus or nursing child are
             unknown;

          5. Must be able and willing to give written informed consent;

          6. In the absence of rapidly progressing disease, the interval from prior treatment to
             time of study drug administration should be at least 2 weeks for cytotoxic agents, or
             at least 5 half-lives for noncytotoxic agents. If the patient is on hydroxyurea to
             control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for
             at least 48hours before initiation of treatment on this protocol. Persistent chronic
             clinically significant toxicities from prior chemotherapy must not be greater than
             grade 1; and

          7. Patients must have the following clinical laboratory values, unless abnormal parameter
             level is considered related to leukemia: Creatinine (Cr) less than or equal to 2.0
             mg/dL, Bilirubin Normal limits (less than or equal to 1.5 * Upper Limit of Normal
             (ULN) with liver metastases) unless considered due to Gilbert's syndrome, Aspartate
             aminotransferase (AST) less than or equal to 3.0 * ULN, Alanine aminotransferase (ALT)
             less than or equal to 3.0 * ULN

        Exclusion Criteria:

          1. Uncontrolled intercurrent illness including, but not limited to uncontrolled
             infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric
             illness/social situations that would limit compliance with study requirements;

          2. Active heart disease including myocardial infarction within previous 3 months,
             symptomatic coronary artery disease, arrhythmias not controlled by medication, or
             uncontrolled congestive heart failure; and

          3. Patients receiving any other standard or investigational treatment for their
             hematologic malignancy.