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Brief Title: (NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors
Official Title: A Phase 1 Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors
Study ID: NCT02508532
Brief Summary: This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antineoplastic activity of avapritinib (formerly BLU-285), administered orally (PO), in adult patients with unresectable GIST or other relapsed or refractory solid tumors. The study consists of 2 parts, a dose-escalation part (Part 1) and an expansion part (Part 2).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Scottsdale Healthcare Hospitals DBA HonorHealth, Scottsdale, Arizona, United States
Sarcoma Oncology Center, Santa Monica, California, United States
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Cancer Treatment Centers of America, Atlanta, Georgia, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Oregon Health and Science University, Portland, Oregon, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
Leuven Cancer Institute University Hospitals Leuven, Leuven, , Belgium
Centre Leon Berard, Lyon, , France
Institut Gustave Roussy, Paris, , France
University of Duisburg-Essen, Essen, , Germany
Fondazione IRCCS - Istituto Nazinale dei Tumori, Milan, , Italy
Asan Medical Center, Seoul, , Korea, Republic of
Erasmus MC Cancer Institute, Rotterdam, , Netherlands
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie w Warszawie, Warsaw, , Poland
Vall d' Hebron Institute of Oncology (VHIO), Barcelona, , Spain
Royal Marsden Hospital, London, , United Kingdom