A Phase I/II Trial of the MUC1 Inhibitor, GO-203-2C in Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase I/II Trial of the MUC1 Inhibitor, GO-203-2C in Patients With Relapsed or Refractory Acute Myeloid Leukemia
This research study is studying a targeted therapy known as GO-203-2C as a possible treatment for with acute myeloid leukemia (AML) both alone and in combination with decitabine. GO-203-2c targets cancer cells, while leaving healthy cells unaffected.This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies.
Phase I
Phase II
Inclusion Criteria:
To be considered eligible for enrollment into this study, all of the following inclusion criteria must be met during the screening period:
Documented AML by peripheral blood and bone marrow analyses meeting WHO criteria, excluding patients with acute promyelocytic leukemia (APL)
Patients with AML refractory to primary induction chemotherapy, relapsed disease, or age ≥ 60 and not appropriate for standard cytotoxic therapy due to age, performance status, and/or adverse risk factors according to the treating physician
Age ≥ 18 years
Karnofsky performance status ≥ 50% or ECOG performance status 0-2
Life expectancy ≥ 6 weeks
Able to understand the investigational nature of this study and to provide written consent to participate in it
Signed written IRB-approved Informed Consent document
Adequate hepatic and renal function:
Negative pregnancy test in women of child-bearing potential
Women and men of child-producing potential must agree to use effective contraceptive methods during the study period (including post-treatment observation period)
Exclusion Criteria: