Selumetinib + Azacitidine for Leukemia
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have received any anti-cancer therapy within 14 days before starting the study, except for hydroxyurea, which can be continued if needed.
What data supports the effectiveness of the drug Azacitidine for leukemia?
Azacitidine has been shown to be effective and safe in treating higher-risk myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML), including in older patients, by prolonging overall survival compared to conventional care. It is recommended as the first-line treatment for most patients with higher-risk MDS.12345
What safety data exists for Azacitidine in humans?
What makes the drug Selumetinib + Azacitidine unique for treating leukemia?
The combination of Selumetinib and Azacitidine is unique because it combines a MEK inhibitor (Selumetinib) with a hypomethylating agent (Azacitidine), potentially offering a novel approach to targeting leukemia cells by affecting different pathways involved in cancer cell growth and survival.1351112
Research Team
Olatoyosi M. Odenike
Principal Investigator
University of Chicago
Eligibility Criteria
Adults with high-risk chronic blood cancers like Myeloid Leukemia, who haven't been treated with MEK inhibitors before, can join. They should have certain levels of disease severity and organ function, no recent cancer treatments except possibly hydroxyurea, and not be pregnant or breastfeeding. Participants must use effective birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive azacitidine subcutaneously on days 1-7 and selumetinib on days 8-21 in 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for long-term outcomes and survival
Treatment Details
Interventions
- Azacitidine
- Selumetinib
Azacitidine is already approved in European Union, United States, Canada, Japan for the following indications:
- Acute myeloid leukemia
- Chronic myelomonocytic leukemia
- Myelodysplastic syndromes
- Myelodysplastic syndromes
- Chronic myelomonocytic leukemia
- Myelodysplastic syndromes
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Acute myeloid leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor