A Phase II Study of Tosedostat in Combination With Either Cytarabine or Decitabine in Newly Diagnosed AML or High-Risk MDS
I. To determine the 4 month survival and complete remission (CR) rates of tosedostat in
combination with either cytarabine or decitabine in untreated acute myeloid leukemia (AML)
or high-risk myelodysplastic syndrome (MDS).
I. To assess safety and tolerability of tosedostat in combination with either cytarabine or
II. To determine the treatment related mortality defined as death within the first 30 days
of beginning treatment.
III. To estimate rates of disease-free survival (DFS) and the 1 year overall survival (OS).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive tosedostat orally (PO) once daily (QD) on days 1-35 and cytarabine
intravenously (IV) on days 1-5.
ARM II: Patients receive tosedostat PO QD on days 1-35 and decitabine IV on days 1-5.
In both arms, treatment repeats every 35 days for up to 3 courses in the absence of disease
progression or unacceptable toxicity. Patients achieving CR or partial CR (pCR) may receive
2 additional courses of treatment.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then annually for 3 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients alive (survival rate)
Success measured by improvement of survival rate to 80% from the historical 60% while not decreasing the CR rate to < 30% from the historical 50%.
4 months after beginning treatment
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|