RecruitingPhase 1NCT03326310

Selumetinib and Azacitidine in High Risk Chronic Blood Cancers

Phase I Study of MEK Inhibitor Selumetinib in Combination With Azacitidine in Patients With Higher Risk Chronic Myeloid Neoplasia: MDS, MDS/MPNs, and Myelofibrosis

Sponsor

University of Chicago

Enrollment

18 participants

Start Date

Sep 4, 2018

Study Type

INTERVENTIONAL

Conditions

Chronic Myeloid Leukemia Myelofibroses

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the combination of two drugs — selumetinib (which blocks a cancer cell signalling pathway called MEK) and azacitidine (a chemotherapy drug that changes how genes are read) — in patients with high-risk chronic blood cancers including MDS, CMML, and MPN. **You may be eligible if...** - You are 18 or older - You have been diagnosed with high-risk MDS (myelodysplastic syndrome), CMML (a type of blood/bone marrow cancer), or a related blood disorder (MPN) - Your disease meets specific risk criteria confirmed by your doctor - Your organ function is adequate for treatment **You may NOT be eligible if...** - Your blood cancer is at a lower risk level - You have already received azacitidine or a MEK inhibitor - You have serious heart, liver, or eye problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAzacitidine

Patients will receive azacitidine 75 mg/m2 as a subcutaneous injection on days 1-7. The dose of azacitidine 75 mg/m2 will remain unchanged, unless a dose reduction is required based on toxicities (dose level -1 = selumetinib 50 mg PO twice daily and azacitidine 50 mg/m2). Subjects will continue on this schedule in cycles of 28 days duration in the absence of disease progression

DRUGSelumetinib

Patients will receive selumetinib administered by mouth on days 8-21. The starting dose cohort (dose level 1) will receive selumetinib 50 mg PO twice daily on days 8-21. Subsequent planned doses include selumetinib 75 mg PO twice daily (dose level 2) and selumetinib 100 mg PO twice daily (dose level 3). Subsequent dose levels will only be given once the prior dose level has shown acceptable safety. Subjects will continue on this schedule in cycles of 28 days duration in the absence of disease progression.