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).
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Maximum tolerated dose (MTD) of avapritinib (also known as BLU-285)
Timeframe: During cycle 1 (28 days) of treatment
Number of patients with adverse and serious adverse events and changes in physical findings, vital signs, clinical laboratory results and ECG findings
Timeframe: Approximately 24 months
Recommended Phase 2 dose (RP2D) of avapritinib
Timeframe: Approximately 24 months