Clinical trial NCT00405743 (phase 1/phase 2, status: completed)
Conditions: hematologic malignancies, aml
ICD codes: E70.338, E70.339, P09.3, O28.0, P61.8, P61.9, T45.8X1A
Drugs: cp-4055, cp-4055
SMILES: [H]\C(CCCCCCCC)=C(\[H])CCCCCCCC(=O)OC[C@@]1([H])O[C@@]([H])(N2C=CC(=N)N=C2O)[C@@]([H])(O)[C@]1([H])O, [H]\C(CCCCCCCC)=C(\[H])CCCCCCCC(=O)OC[C@@]1([H])O[C@@]([H])(N2C=CC(=N)N=C2O)[C@@]([H])(O)[C@]1([H])O
Eligibility criteria:

        Inclusion Criteria:

        ARM A and B: Phase I CP-4055 single agent 1. Patients must have relapsed/refractory
        leukemias for which no standard therapies are anticipated to result in a durable response
        or have failed potentially curative therapy, or have refused or are considered unsuitable
        for standard therapy

        ARM C: CP-4055 in combination with idarubicin

          1. Patients with relapsed/refractory AML for which no standard therapies are anticipated
             to result in a durable response or who have failed potentially curative therapy, or
             who refuse or are considered unsuitable for standard therapy

             ARM A, B, C: CP-4055 as single agent and/or in combination with idarubicin

          2. Patients must be 18 years of age or older

          3. Patients must have ECOG performance status (PS) of 0 - 2. See Appendix 3

          4. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically
             sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to
             beginning treatment on this study. Nursing patients are excluded.

             Male and female patients must use acceptable contraceptive methods for the duration of
             time on study, and males also for 3 months after the last CP-4055 dose

          5. Patients must be capable of understanding and complying with parameters as outlined in
             the protocol, and able and willing to sign a written informed consent form

          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.

          7. Patients must have the following clinical laboratory values:

               -  Serum creatinine less or equal to 1.5 x the institutional upper limit of normal
                  (ULN)

               -  Total bilirubin less or equal to 1.5 x the ULN unless considered due to Gilbert's
                  syndrome

               -  Alanine aminotransferase (ALT) (SGPT), or aspartate aminotransferase (AST) (SGOT)
                  less or equal to 2.5 x the ULN unless considered due to organ leukemic
                  involvement

        Phase II

        1. Patients with a confirmed diagnosis of AML who have received cytotoxic chemotherapy

        2 - 7. Identical to inclusion criteria nos. 2 - 7 for phase I

        Exclusion Criteria:

        Phase I AND II

          1. A history of allergic reactions or sensitivity attributed to compounds of similar
             chemical or biologic composition to CP-4055, i.e., ara-C and/or egg

          2. Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C

          3. Pregnant and nursing patients are excluded

          4. Uncontrolled intercurrent illness

          5. Active heart disease

          6. Patients receiving any other standard or investigational cytotoxic treatment for their
             hematologic malignancy other than a maximum of 5 g of hydroxyurea to a maximum of 5
             days in cycle 1 of therapy

          7. Any medical condition which in the opinion of the investigator places the patient at
             an unacceptably high risk for toxicities

             Exclusion criteria no. 8 applies only in arm C:

          8. Patients with hypersensitivity to idarubicin or any other component of the product,
             and/or other anthracyclines or anthracenediones