Spots Global Cancer Trial Database for Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations
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Trial Identification
Brief Title: Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations
Official Title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations (FIGHT-209)
Study ID: NCT05267106
Interventions
Study Description
Brief Summary: This is an open-label, monotherapy study of pemigatinib in participants with recurrent glioblastoma (GBM) or other recurrent gliomas, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors with an activating FGFR1-3 mutation or fusion/rearrangement. This study consists of 2 cohorts, Cohorts A, and B, and will enroll approximately 82 participants into each cohort. Participants will receive pemigatinib 13.5 mg QD on a 2-week on-therapy and 1-week off-therapy schedule as long as they are receiving benefit and have not met any criteria for study withdrawal.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Valkyrie Clinical Trials, Beverly Hills, California, United States
City of Hope National Medical Center, Duarte, California, United States
Providence Medical Foundation, Fullerton, California, United States
Usc Norris Comprehensive Cancer Center, Los Angeles, California, United States
Stanford Neuroscience Health Center, Sacramento, California, United States
Sharp Memorial Hospital, San Diego, California, United States
University of California San Francisco, San Francisco, California, United States
Providence St Joseph Hospital Orange Center For Cancer Prevention and Treatment, Santa Monica, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
Baptist Md Anderson Cancer Center, Jacksonville, Florida, United States
Miami Cancer Institute, Miami, Florida, United States
Orlando Health Cancer Institute Downtown Orlando, Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute Hospital, Tampa, Florida, United States
University of Illinois Hospital & Health Sciences System, Chicago, Illinois, United States
University of Iowa Hospital and Clinics, Iowa City, Iowa, United States
University Medical Center New Orleans, New Orleans, Louisiana, United States
University of Minnesota Health Clinics and Surgery Center, Minneapolis, Minnesota, United States
Northwell Health, Lake Success, New York, United States
Columbia University Irving Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
East Carolina University, Greenville, North Carolina, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
UC Health At Cincinnati Va Medical Center, Cincinnati, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
University of Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania, United States
Tennessee Oncology, Chattanooga, Tennessee, United States
Tennessee Oncology, Nashville, Tennessee, United States
Baylor University Medical Center, Dallas, Texas, United States
Houston Methodist Hospital, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Aalborg Universitets Hospital, Aalborg, , Denmark
Rigshospitalet Uni of Hospital of Copenhagen, Copenhagen, , Denmark
Odense University Hospital, Odense C, , Denmark
Chru de Lille Hopital Claude Huriez, Lille Cedex, , France
Chu Hopital de La Timone, Marseille, , France
Hospital Universitaire Pitie-Salpetriere, Paris, , France
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole, Toulouse, , France
Universitatsklinikum Bonn Aoer, Bonn, , Germany
Klinikum Der Johann Wolfgang Goethe University, Frankfurt, , Germany
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
University Hospital Tuebingen, Tuebingen, , Germany
Ospedale Bellaria, Bologna, , Italy
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele, Milano, , Italy
Iov - Istituto Oncologico Veneto Irccs, Padova, , Italy
A.S.L. Napoli 1 Centro Ospedale Del Mare, Ponticelli, , Italy
Irccs Istituto Clinico Humanitas, Rozzano, , Italy
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza, Torino, , Italy
University of Tokyo Hospital, Bunkyo-ku, , Japan
National Cancer Center Hospital, Chuo-ku, , Japan
Kyushu University Hospital, Fukuoka-shi, , Japan
Kyoto University Hospital, Kyoto-shi, , Japan
Nagoya University Hospital, Nagoya-shi, , Japan
Tohoku University Hospital, Sendai-shi, , Japan
Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis, Amsterdam, , Netherlands
Erasmus Mc Cancer Institute, Rotterdam, , Netherlands
Hospital Del Mar, Barcelona, , Spain
Hospital General Universitario Vall D Hebron, Barcelona, , Spain
Hospital Clinic Barcelona Main, Barcelona, , Spain
Hospital de La Santa Creu I Sant Pau, Barcelona, , Spain
Ico Girona Hospital Universitari de Girona Dr Josep Trueta, Girona, , Spain
Ico Institut Catala D Oncologia, L'hospitalet de Llobregat, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario Ramon Y Cajal, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Hm Sanchinarro, Madrid, , Spain
Clinica Universidad de Navarra (Cun), Pamplona, , Spain
Hospital General de Catalunya, Sant Cugat Del Valles, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Addenbrooke'S Hospital, Cambridge, , United Kingdom
Velindre Cancer Centre, Cardiff, , United Kingdom
St James'S University Hospital, Leeds, , United Kingdom
Guys Hospital, London, , United Kingdom
The Royal Marsden Nhs Foundation Trust - Sutton, London, , United Kingdom
The Royal Marsden Nhs Foundation Trust - Chelsea, London, , United Kingdom
The Christie Nhs Foundation Trust Uk, Manchester, , United Kingdom
The Clatterbridge Cancer Centre, Wirral, , United Kingdom
Contact Details
Name: Victoria Ebiana, MD
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR
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