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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 below

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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:

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I had major surgery less than 14 days before starting the study drug.

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I have a serious heart condition that is not under control.

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My cancer is Philadelphia chromosome positive.

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I am not eligible for a stem cell transplant from a donor.

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I have been treated with HMA therapy for my current condition.

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I have acute myeloid leukemia.

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I have been treated with a KIT inhibitor like avapritinib.

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I have taken hydroxyurea within the last week before starting elenestinib.

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I haven't taken any blood cell growth factors, except for erythropoietin, in the last 14 days.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4 years for reporting.

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

0 / 11Eligibility criteria met