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Brief Title: A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies
Official Title: A Multicenter Phase 1, Open-Label Study of DCC-2618 to Assess Safety, Tolerability, Efficacy, and Pharmacokinetics in Patients With Advanced Malignancies
Study ID: NCT02571036
Brief Summary: This is a Phase 1, open-label, first-in-human (FIH) dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of DCC-2618, administered orally (PO), in adult patients with advanced malignancies. The study consists of 2 parts, a dose-escalation phase, and an expansion phase. All active patients (from both dose-escalation and expansion phases) will then transition into an extension phase.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Honor Health (GIST, mastocytosis, other solid tumors), Scottsdale, Arizona, United States
UCLA Hematology Center (mastocytosis), Los Angeles, California, United States
UCLA (glial malignancies only), Los Angeles, California, United States
Stanford University Comprehensive Cancer Center (GIST), Palo Alto, California, United States
Stanford University Hematology Clinic (mastocytosis), Palo Alto, California, United States
UCSF (glial malignancies only), San Francisco, California, United States
Mayo Clinic (GIST, mastocytosis, glial malignancies, other solid tumors), Jacksonville, Florida, United States
University of Miami (GIST, mastocytosis, glial malignancies, other solid tumors), Miami, Florida, United States
Dana Farber Cancer Institute (GIST, mastocytosis, glial malignancies, other solid tumors), Boston, Massachusetts, United States
Colombia University Medical Center (mastocytosis), New York, New York, United States
Memorial Sloan Kettering Cancer Center (GIST, mastocytosis, glial malignancies, other solid tumors), New York, New York, United States
OHSU (GIST & mastocytosis only), Portland, Oregon, United States
Fox Chase Cancer Center (GIST only), Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center (GIST, mastocytosis, glial malignancies, other solid tumors), Houston, Texas, United States
Huntsman Cancer Institute (GIST, mastocytosis, glial malignancies, other solid tumors), Salt Lake City, Utah, United States
Virginia Commonwealth University School of Medicine (mastocytosis), Richmond, Virginia, United States
Princess Margaret Cancer Centre (GIST, other solid tumors), Toronto, , Canada
Uniklinik RWTH Aachen (mastocytosis, GIST, and other solid tumors), Aachen, , Germany
HELIOS Klinikum Berlin-Buch (GIST, and other solid tumors), Berlin, , Germany
Essen University Hospital (mastocytosis, GIST, and other solid tumors), Essen, , Germany
Freiburg University Hospital (mastocytosis, and other solid tumors), Freiburg, , Germany
University Medical Centre Mannheim (mastocytosis), Mannheim, , Germany
University Hospital of Verona (mastocytosis), Verona, , Italy
Leiden University Medical Center (GIST and other solid tumors), Leiden, , Netherlands
Guy's Hospital (mastocytosis only), London, , United Kingdom
Royal Marsden Hospital (GIST, glial malignancies, other solid tumors), London, , United Kingdom
Name: Deciphera Pharmaceuticals, LLC
Affiliation: Deciphera Pharmaceuticals LLC
Role: STUDY_DIRECTOR