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(EXPLORER) Study of BLU-285 in Patients With Advanced Systemic Mastocytosis (AdvSM) and Relapsed or Refractory Myeloid Malignancies

NCT02561988 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2023-03-17

No results posted yet for this study

Summary

This is a Phase 1, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antineoplastic activity of avapritinib (also known as BLU-285), administered orally (PO), in adult patients with advanced systemic mastocytosis and other relapsed or refractory myeloid malignancies. The study consists of 2 parts:, dose-escalation (Part 1) and expansion (Part 2).

Conditions

  • Aggressive Systemic Mastocytosis
  • Systemic Mastocytosis-associated Hematologic Non-mast Cell Disease
  • Mast Cell Leukemia
  • Relapsed or Refractory Myeloid Malignancies

Interventions

DRUG

Avapritinib

Sponsors & Collaborators

  • Blueprint Medicines Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-10
Primary Completion
2022-10-05
Completion
2023-01-19

Countries

  • United States
  • United Kingdom

Study Locations

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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 NCT02561988 on ClinicalTrials.gov