The purpose of this study is to explore safety, tolerability, including the maximum tolerated
dose, and antitumor activity of NMS-03592088 in adult patients with relapsed or refractory
Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML).
This is an open-label Phase I/II, first-in-human, multi-center clinical study in sequential
cohorts of patients with relapsed or refractory AML or CMML who have exhausted standard
treatment options or for whom standard therapy is considered unsuitable. The study is
designed to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics
(PD) and to explore anticancer activity of NMS-03592088, a FLT3 (Fms-like tyrosine kinase 3),
KIT (v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog ) and CSF1R (Colony
stimulating factor-1 receptor) inhibitor. The study drug will be administered orally once
daily for 21 consecutive days followed by 7 days of rest (each cycle is 28 days, schedule A)
or once daily for 28 consecutive days (each cycle is 28 days, schedule B). The study will be
conducted in two parts: a Phase I dose escalation and dose expansion part including patients
with AML and CMML and a single-stage Phase II exploratory study comprising two parallel
cohorts of selected patients that are more likely to respond to the drug: a cohort of AML
FLT3 mutated patients and a second one of patients with CMML. Patients previously treated
with FLT3 inhibitors are allowed to participate.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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