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Brief Title: (EXPLORER) Study of BLU-285 in Patients With Advanced Systemic Mastocytosis (AdvSM) and Relapsed or Refractory Myeloid Malignancies
Official Title: A Phase 1 Study of BLU-285 in Patients With Advanced Systemic Mastocytosis (AdvSM) and Relapsed or Refractory Myeloid Malignancies
Study ID: NCT02561988
Brief 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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Stanford Cancer Institute, Stanford, California, United States
University of Colorado Cancer Center, Denver, Colorado, United States
Emory University, Atlanta, Georgia, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
Mount Sinai Hospital, New York, New York, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Guy's Hospital, London, , United Kingdom