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Brief Title: Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations
Official Title: A Phase 1/2 Study of ARQ 087 in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations, Including Intrahepatic Cholangiocarcinoma With FGFR2 Gene Fusion
Study ID: NCT01752920
Brief Summary: This was an open-label, Phase 1/2, dose escalation and signal finding study of derazantinib administered to patients with advanced solid tumors (Part 1; Dose Escalation/Food-effect Cohorts) or with advanced solid tumors with FGFR genetic aberrations, including iCCA with FGFR2 gene fusion (Part 2; Expanded Cohort, signal finding).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Scottsdale Healthcare Research Institute, Scottsdale, Arizona, United States
Emory University, Winship Cancer Institute, Atlanta, Georgia, United States
Karmanos Cancer Institute, Detroit, Detroit, Michigan, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Montefiore-Einstein Center for Cancer Care, Bronx, New York, United States
University of Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
START - South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States
University of Washington, Seattle, Washington, United States
Istituto Clinico Humanitas, Milan, , Italy
Istituto Nazionale Tumori (National Cancer Institute), Milan, , Italy
Instituto Oncologico Veneto, IRCCS, Padova, , Italy
Azienda Ospedaliero-Universitaria Pisana - U.O. Oncologia Medica 2 Univ., Pisa, , Italy
Name: Marc Engelhardt, MD
Affiliation: Basilea Pharmaceutica
Role: STUDY_DIRECTOR