Eligibility NCT00405743 Hematologic Malignancies Inclusion Criteria Age at least 18 Years Yes
No
ARM A and B: Phase I CP-4055 single agent Yes
No
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 Yes
No
ARM C: CP-4055 in combination with idarubicin Yes
No
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 Yes
No
ARM A, B, C: CP-4055 as single agent and/or in combination with idarubicin Yes
No
ECOG performance status finding <= 2 Yes
No
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. Yes
No
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 Yes
No
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 Yes
No
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. Yes
No
Patients must have the following clinical laboratory values: Yes
No
Serum creatinine <= 1.5 x the institutional upper limit of normal (ULN) Yes
No
Total bilirubin <= 1.5 x the ULN unless considered due to Gilbert's syndrome Yes
No
Alanine aminotransferase (ALT) (SGPT), or aspartate aminotransferase (AST) (SGOT) <= 2.5 x the ULN unless considered due to organ leukemic involvement Yes
No
Patients with a confirmed diagnosis of AML who have received cytotoxic chemotherapy Yes
No
Exclusion Criteria 
