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Kinase Inhibitor
Elenestinib for Blood Cancers (AZURE Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Blueprint Medicines Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
Be older than 18 years old
Must not have
Participant has had a major surgical procedure within 14 days of the first dose of study drug
Clinically significant, uncontrolled, cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test a drug called elenestinib (BLU-263) in patients with Advanced Systemic Mastocytosis (AdvSM) and other related blood cancers. It
Who is the study for?
This trial is for people with advanced systemic mastocytosis or related blood cancers, who are not responding to current treatments. They must be able to perform daily activities (with varying degrees of difficulty), have a recent bone marrow biopsy, and agree to follow-up tests. It's not suitable for those already on effective cancer treatment.
What is being tested?
The study is testing elenestinib (BLU-263) alone and combined with azacitidine in patients with advanced systemic mastocytosis. It aims to find the right dose, check safety and tolerability, and measure how well these treatments work over a period of up to four years.
What are the potential side effects?
While specific side effects aren't listed here, common ones for cancer drugs like BLU-263 may include nausea, fatigue, risk of infection, bleeding issues, liver problems among others. Azacitidine can also cause similar side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of the day.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had major surgery less than 14 days before starting the study drug.
Select...
I have a serious heart condition that is not under control.
Select...
My cancer is Philadelphia chromosome positive.
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I am not eligible for a stem cell transplant from a donor.
Select...
I have been treated with HMA therapy for my current condition.
Select...
I have acute myeloid leukemia.
Select...
I have been treated with a KIT inhibitor like avapritinib.
Select...
I have taken hydroxyurea within the last week before starting elenestinib.
Select...
I haven't taken any blood cell growth factors, except for erythropoietin, in the last 14 days.
Select...
I have a history of heart rhythm issues or my family does.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Heart rate
Combined Modality Therapy
Mutagenicity Tests
Secondary study objectives
Mastocytosis
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: MonotherapyExperimental Treatment1 Intervention
Participants with AdvSM (ASM, SM-AHN, or MCL) will receive BLU-263 monotherapy.
Group II: Combination therapyExperimental Treatment2 Interventions
Participants with high risk and very high risk systemic mastocytosis with an associated hematologic neoplasm (SM-AHN) of non-MC lineage will receive BLU-263 in combination with azacitidine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Find a Location
Who is running the clinical trial?
Blueprint Medicines CorporationLead Sponsor
29 Previous Clinical Trials
6,138 Total Patients Enrolled