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A Phase I Study of ICP-248 in Combination with Azacitidine for the Treatment in Patients with Myeloid Malignancies

UCI Specialty Area: Cancer
Principal Investigator: Deepa Jeyakumar
A Study On:
Myeloid and Monocytic Leukemia

Study Description

Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous leukemia and Myelodysplastic Syndromes.

Eligibility

Eligible subjects must meet all of the following criteria:

Subject must have confirmation of diagnosis of AML (except for acute promyelocytic leukemia [APL]) or MDS per 2016 World Health Organization (WHO) criteria.

For AML (except for APL) cohort:

Previously treated relapsed/refractory AML subjects

Treatment-naïve AML subjects should be: ≥60 years of age OR ≥18 years and <60 years will be eligible if the subject has at least one of the following co-morbidities, which make the subject unfit for intensive chemotherapy

For MDS cohort: Adult TN MDS and R/R MDS: revised International Prognostic Scoring System (IPSS-R) score > 3 and bone marrow blasts ≥ 5%.

Subject must have a projected life expectancy of at least 12 weeks.

Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft-Gault formula.

Subject must have adequate liver function

R/R AML or R/R MDS with no response or intolerance to post azacitidine or BCL-2i.

Subject has acute promyelocytic leukemia (French-American-British Class M3 AML) .

Subject has known central nervous system (CNS) leukemia.

Suggest patients with active hepatitis B or C virus infection

History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.

Subjects have another active malignancy within the past 2 years before study entry, except for curatively treated.

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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Eric Vilain, MD, PhD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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