Trials / Completed
CompletedNCT02561988
(EXPLORER) Study of BLU-285 in Patients With Advanced Systemic Mastocytosis (AdvSM) and Relapsed or Refractory Myeloid Malignancies
A Phase 1 Study of BLU-285 in Patients With Advanced Systemic Mastocytosis (AdvSM) and Relapsed or Refractory Myeloid Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- Blueprint Medicines Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Avapritinib |
Timeline
- Start date
- 2016-03-10
- Primary completion
- 2022-10-05
- Completion
- 2023-01-19
- First posted
- 2015-09-29
- Last updated
- 2023-03-17
Locations
11 sites across 2 countries: United States, United Kingdom
Source: ClinicalTrials.gov record NCT02561988. Inclusion in this directory is not an endorsement.