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NCT05609942 · ClinicalTrials.gov registry record · Phase 1
Study of Elenestinib (BLU-263) in Advanced Systemic Mastocytosis (AdvSM) and and Other KIT Altered Hematologic Malignancies
A Phase 1 study, sponsored by Blueprint Medicines Corporation.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT05609942: Clinical Trial Phase 1 study, sponsored by Blueprint Medicines Corporation.
NCT05609942 is a Phase 1 study that was terminated before completion, run by Blueprint Medicines Corporation. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05609942, a Phase 1 study, was terminated before completion, sponsored by Blueprint Medicines Corporation.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
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.
Primary Outcome
Monotherapy: The Recommended Dose (RD) will be primarily determined by the number of DLTs in the first 28 days of treatment with elenestinib (BLU-263) monotherapy.
Interventions
- DRUG Azacitidine
- DRUG BLU-263
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2023-09-25 |
| Est. Completion | 2025-03-10 |
| Phase | Phase 1 |
Why NCT05609942 stopped before completion
NCT05609942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Azacitidine is the first listed.
NCT05609942 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05609942 about?
NCT05609942 is a clinical study titled "Study of Elenestinib (BLU-263) in Advanced Systemic Mastocytosis (AdvSM) and and Other KIT Altered Hematologic Malignancies". 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 elenes...
What is the current status of trial NCT05609942?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2023-09-25. Estimated completion is 2025-03-10.
What interventions are being tested in trial NCT05609942?
The interventions under investigation include: Azacitidine (DRUG), BLU-263 (DRUG).
Who is sponsoring clinical trial NCT05609942?
This trial is sponsored by Blueprint Medicines Corporation, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05609942's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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