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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 is a Phase 1 study that was terminated before completion, run by Blueprint Medicines Corporation. The registered enrollment target is 9 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05609942
The ClinicalTrials.gov registry entry for NCT05609942 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Blueprint Medicines Corporation, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Azacitidine is the first listed.
NCT05609942 reports 0 study locations.
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.
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