Actively Recruiting
Selumetinib and Azacitidine in High Risk Chronic Blood Cancers
Led by University of Chicago · Updated on 2025-12-29
18
Participants Needed
1
Research Sites
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase I, open-label, dose-escalation study to determine the MTD of selumetinib when combined with the standard dose of azacitidine. Treatment will begin within 28 days of screening procedures. Treatment will continue indefinitely, provided that the patient continues to derive benefit. A patient will be taken off study for reasons described in detail in section 3.12 including disease progression, unacceptable toxicity, inter-current illness, withdrawal of consent, or at the discretion of the investigator. Patients will be followed for 12 weeks after the last dose of study drug, until any study treatment related toxicities have stabilized, or until death. The total duration of the study is expected to be approximately 24 months.
CONDITIONS
Official Title
Selumetinib and Azacitidine in High Risk Chronic Blood Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than or equal to 18 years
- Histologic confirmation of MDS with intermediate-2 or high risk by IPSS or intermediate, high, or very high risk by IPSS-R, relapsed/refractory disease, requiring therapy based on cytopenias or excess blasts
- Histologic confirmation of MDS/MPN including CMML, atypical CML, or MDS/MPN-Unclassifiable with relapsed/refractory disease or untreated subsets requiring therapy
- Histologic confirmation of myelofibrosis with intermediate-2 or high risk by DIPSS, refractory or intolerant to JAK inhibitor, or ineligible for ruxolitinib due to cytopenias, requiring therapy
- No prior exposure to a MEK inhibitor
- ECOG performance status of 2 or less
- Adequate kidney function with serum creatinine 4 1.5 x ULN or creatinine clearance >30 mL/min
- Adequate liver function with conjugated bilirubin 4 2 x ULN and AST and ALT 4 3 x ULN
- At least 2 weeks since major surgery, radiation, or participation in other trials and recovered from related toxicities
- Negative pregnancy test within 2 weeks prior to enrollment for females of childbearing potential
- Use of effective contraception by all females and males during the study and for 6 months after
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Receipt of any anti-cancer therapy within 14 days before study entry except hydroxyurea, which may be continued through cycle 1 to control WBC
- Concurrent active malignancy except early stage basal or squamous cell skin cancer
- Active cardiac conditions including uncontrolled hypertension, recent acute coronary syndrome, uncontrolled angina, symptomatic heart failure, left ventricular ejection fraction <50%, severe valvular heart disease, or atrial fibrillation with ventricular rate >100 bpm
- Ophthalmologic conditions such as current or past central serous retinopathy, retinal vein occlusion, intraocular pressure >21 mmHg, or uncontrolled glaucoma
- Any uncontrolled illness posing undue risk including active infection, symptomatic cardiac or pulmonary disease, ventricular arrhythmia, or psychiatric illness
- Pregnant or lactating patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
C
Cancer Clinical Trials Office
CONTACT
O
Olatoyosi Odenike, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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