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

NCT05609942 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-04-10

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate elenestinib (BLU-263) in participants with Advanced Systemic Mastocytosis (AdvSM), SM with an associated hematologic neoplasm (SM-AHN), and other hematologic malignancies. The main questions it aims to answer are:

* Determine Recommended Dose of elenestinib (BLU-263) monotherapy for participants with AdvSM
* Safety and tolerability of elenestinib (BLU-263) monotherapy
* Efficacy of elenestinib (BLU-263) monotherapy in participants with AdvSM
* Determine Recommended Dose of elenestinib (BLU-263) in combination with azacitidine in participants with AdvSM
* Safety and tolerability of elenestinib (BLU-263) in combination with azacitidine
* Efficacy of elenestinib (BLU-263) in combination with azacitidine in participants with AdvSM

The estimated study duration for each participant will be approximately 4 years: 2 years of treatment followed by 2 years of follow-up. Participants may be required to attend monthly visits for the first six months, followed by quarterly visits for the remainder of the study.

Conditions

Interventions

DRUG

BLU-263

BLU-263 Oral Tablets

DRUG

Azacitidine

Azacitidine powder for suspension for intravenous infusion / subcutaneous injection

Sponsors & Collaborators

  • Blueprint Medicines Corporation

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-25
Primary Completion
2025-01-14
Completion
2025-03-10
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Netherlands
  • Norway
  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05609942 on ClinicalTrials.gov