Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase I Study of MEK Inhibitor MEK162 Combined With Idarubicin and Cytarabine Induction in Patients With Relapsed/Refractory RAS-Mutated Acute Myeloid Leukemia
This phase I trial studies the MEK inhibitor MEK162 to see if it is safe in patients when combined with idarubicin and cytarabine. MEK inhibitor MEK162 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving MEK inhibitor MEK162, cytarabine, and idarubicin may be an effective treatment for acute myeloid leukemia.
PRIMARY OBJECTIVES:
I. Determine maximum tolerated dose (MTD) of MEK162 (MEK inhibitor MEK162) in patients with
RAS-mutated acute myeloid leukemia (AML) when combined with sequential induction chemotherapy
(3+4) as measured by development of grade 3-4 dose-limiting toxicities (DLT).
SECONDARY OBJECTIVES:
I. Analyze downstream inhibition of RAS signaling following therapy with single-agent MEK162
with exploratory pharmacodynamics (PD) studies.
II. Perform preliminary efficacy analysis of combination of MEK162 and induction chemotherapy
(3+4) in patients with RAS-mutated AML by measuring complete remission rate, 2-year overall
survival, and duration of response.
OUTLINE:
INDUCTION THERAPY: Patients receive MEK inhibitor MEK162 orally (PO) twice daily (BID) on
days -4 to -1 and days 5-18, cytarabine intravenously (IV) continuously over 24 hours on days
1-4, and idarubicin IV over 1 hour on days 1-3. Patients may receive a second course of
induction at the discretion of the principal investigator.
POST-REMISSION THERAPY: Patients receive cytarabine IV continuously over 24 hours on days
1-3, idarubicin IV over 1 hour on days 1 and 2, and MEK inhibitor MEK 162 PO BID on days
4-17. Treatment repeats every 28 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
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