Description:

ODM derived from http://clinicaltrials.gov/show/NCT00405743

Link:

http://clinicaltrials.gov/show/NCT00405743

Keywords:
Versions (3) ▾
  1. 12/9/13
  2. 4/15/14
  3. 9/20/21
Uploaded on:

September 20, 2021

DOI:
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License:
Creative Commons BY 4.0
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Eligibility NCT00405743 Hematologic Malignancies

Details

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Age at least 18 Years
ARM A and B: Phase I CP-4055 single agent
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
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
ECOG performance status finding <= 2
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
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
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.
Patients must have the following clinical laboratory values:
Serum creatinine <= 1.5 x the institutional upper limit of normal (ULN)
Total bilirubin <= 1.5 x the ULN unless considered due to Gilbert's syndrome
Alanine aminotransferase (ALT) (SGPT), or aspartate aminotransferase (AST) (SGOT) <= 2.5 x the ULN unless considered due to organ leukemic involvement
Patients with a confirmed diagnosis of AML who have received cytotoxic chemotherapy
Exclusion Criteria
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
Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C
Pregnant and nursing patients are excluded
Uncontrolled intercurrent illness
Active heart disease
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
Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
Performed Exclusion Criterion
Patients with hypersensitivity to idarubicin or any other component of the product, and/or other anthracyclines or anthracenediones
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