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Acute Myeloid Leukemia (AML)

Tosedostat with Cytarabine or Decitabine for AML
A Phase II Study of Tosedostat in Combination With Either Cytarabine or Decitabine in Newly Diagnosed AML or High-Risk MDS
Status Conditions Phase Study ID
Recruiting Acute Myeloid Leukemia Phase II NCT01567059
Summary

In this study the investigators will examine a new oral chemotherapy drug called tosedostat, in combination with cytarabine or decitabine. Tosedostat is experimental, meaning it has not been approved by the U.S. Food and Drug Administration (FDA). Tosedostat is thought to work by decreasing the availability of amino acids (building blocks the cell needs to make proteins) in cells. It has been shown in early studies to have activity against a variety of cancers, including leukemias.


Investigator
John M. Pagel, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
  • All adults with untreated AML or high-risk MDS (10-19% marrow blasts) including those with prior myelodysplasia (MDS)/AML, therapy-related AML, AML with trilineage dysplasia (AML-TLD), and AML with adverse cytogenetics; patients may be enrolled if they received prior treatment with hydroxyurea to control blood counts or demethylating agents specifically for the purpose of treating MDS
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 2
  • Serum creatinine =< 2.0 mg/dL; if serum creatinine > 2.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 50 mL/min/1.73 m^2 as calculated by the Modification of Diet in Renal Disease equation
  • Serum bilirubin =< 1.5 × upper limit of normal (ULN) (in the absence of Gilbert's syndrome)
  • Aspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 × ULN
  • Alkaline phosphatase =< 2.5 × ULN
  • Male subjects, even if surgically sterilized (i.e., status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse
  • Female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to completely abstain from heterosexual intercourse
Exclusions (conditions that would prevent participation in this study)
  • Favorable AML features defined as the following:

    • t(8;21)(q22;q22); RUNX1-RUNX1T1
    • inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
    • Mutated nucleophosmin (NPM)1 without fms-like tyrosine kinase receptor-3 (FLT3)-internal tandem duplication (ITD) (normal karyotype)
    • Mutated CCAAT/Enhancer Binding Protein Alpha (CEBPA) (normal karyotype)
  • Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol
  • Active uncontrolled infection
  • Known infection with human immunodeficiency virus (HIV)
  • Medical condition, serious concurrent illness, or other extenuating circumstance that, in the judgment of the Principal Investigator, could jeopardize patient safety or interfere with the objectives of the study
  • Uncontrolled angina or myocardial infarction within 6 months
  • Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless a screening echocardiogram (ECHO) or multiple gate acquisition scan (MUGA) performed within 1 month prior to study screening results in a left ventricular ejection fraction (LVEF) that is >= 45% (or institutional lower limit of normal value)
  • Diagnosed or treated for another malignancy within 1 year of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
Last Updated
April 06, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.