Phase 1 study to learn about the safety and tolerability of a new investigational study drug, PF-06747143, to find the best dose for treating Acute Myeloid Leukemia.

What we are studying

The purpose of this research study is to learn about the safety and tolerability of a new investigational study drug, PF-06747143, and to find the best dose for treating AML. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA) and is currently not approved for sale in the United States. PF-06747143 is a humanized IgG1 monoclonal antibody. An antibody is a natural protein made by our immune system that binds (or attachs) to other proteins and molecules in the body to fight infection and its ill effects. The PF-06747143 antibody selects and binds to a protein in your body which is called CXCR4.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • INCLUSION CRITERIA
  • Failed or relapsed from at least 2 previous induction regimens
  • Must have been off previous anti-leukemia therapy for at least 2 weeks
  • At least 4 weeks since radiotherapy prior to the first dose of PF-06747143
  • Adequate renal and hepatic function
  • Negative pregnancy test (for females of childbearing potential)
  • EXCLUSION CRITERIA
  • Acute promyelocytic leukemia
  • Chronic graft versus host disease (GVHD)
  • Active GVHD with other than Grade 1 skin involvement
  • Or GVHD requiring immunosuppressive treatment
  • Prior treatment with a compound targeting CXCR4
  • Major surgery within 4 weeks of study entry
  • Known or suspected hypersensitivity to recombinant human proteins

What is involved

  • Physical exam
  • Weight
  • Blod pressure
  • Evaluate your activity level
  • 12-Lead electrocardiograms (ECG)
  • Blood draw
  • Urine test
  • Pregnancy test
  • Bone marrow aspirate or biopsy

Compensation

Comprehensive Cancer Center of Wake Forest University will provide a parking voucher for all study related visits.

Contact Information

Study Coordinator
Teresa Brady, RN
Email
tbrady@wakehealth.edu
Phone
336-716-4703
Principal Investigator
Dr. Bayard Powell

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.