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Kinase Inhibitor

Monotherapy for Systemic Mastocytosis (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 4 years

Awards & highlights

AZURE Trial 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.Check my eligibility

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.See study design

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.

AZURE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself and am up and about more than half of the day.

AZURE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Escalation and Expansion: Number of Participants with Adverse Events (AEs)

Dose Escalation and Expansion: Number of Participants with Serious Adverse Events (SAEs)

Heart rate

+2 more

Secondary outcome measures

Dose Escalation and Dose Expansion: AUC(0-24) of Azacitidine (combination therapy only)

Azacitidine

Dose Escalation and Dose Expansion: Accumulation Ratio of BLU-263

+19 more

AZURE 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Blueprint Medicines CorporationLead Sponsor

29 Previous Clinical Trials

6,142 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants being enrolled in this clinical research study?

"Indeed, the information on clinicaltrials.gov reveals that this trial is actively seeking candidates. The trial was initially posted on September 25th, 2023 and last revised on February 9th, 2024. There are openings for enrollment of up to 67 participants at nine distinct sites."

Answered by AI

At how many different sites is this medical trial being administered?

"The ongoing recruitment for this research is taking place at 9 locations, including Ghent, Palo Alto, and Boston among others. Opting for the site closest to you upon enrollment will help reduce travel requirements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Elenestinib (BLU-263) in Advanced Systemic Mastocytosis (AdvSM) and and Other KIT Altered Hematologic Malignancies

2023. "Study of Elenestinib (BLU-263) in Advanced Systemic Mastocytosis (AdvSM) and and Other KIT Altered Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05609942.

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