Spots Global Cancer Trial Database for Futibatinib in Patients With Specific FGFR Aberrations
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Trial Identification
Brief Title: Futibatinib in Patients With Specific FGFR Aberrations
Official Title: A Phase 2 Study of Futibatinib in Patients With Specific FGFR Aberrations
Study ID: NCT04189445
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors and intrahepatic cholangiocarcinoma \[iCCA\]); patients with gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification; and patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements.
Detailed Description: Study TAS-120-202 is an open-label, multinational, 3-arm Phase 2 study evaluating the efficacy, safety, tolerability, PK, and pharmacodynamics of futibatinib in patients with FGFR aberrations. Eligible patients will be assigned to 1 of 3 treatment cohorts based on diagnosis and FGFR gene aberration status. Patients will receive futibatinib at an oral dose of 20 mg once a day on a continuous 28-day cycle. The study will enroll approximately: * Cohort A: 60 patients with locally advanced, advanced, or metastatic solid tumor harboring FGFR rearrangements other than primary brain tumor or iCCA; * Cohort B: 35 patients with locally-advanced, advanced, or metastatic gastric cancer or gastro-esophageal junction (GEJ) with FGFR2 amplification; * Cohort C: 20 patients with myeloid or lymphoid neoplasms (MLN) with FGFR1 rearrangements Treatment in all cohorts will continue until disease progression, unacceptable toxicity, or any other of the criteria for treatment discontinuation is met. For patients who discontinue treatment for reasons other than disease progression, tumor assessments should be continued until radiologic disease progression is documented or until initiation of subsequent new anticancer therapy (whichever occurs first). Patients will be followed for survival every 12 weeks (±2 weeks) until survival events (deaths) have been reported for 75% of enrolled patients or the study is terminated early by the Sponsor. Additional cohorts may be added in the future in case of new emerging efficacy data.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
UCLA Medical Center, Los Angeles, California, United States
Georgetown University - Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
University of Maryland, Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Henry Ford Hospital, Woodhaven, Michigan, United States
Mercy Clinic Oncology and Hematology - Coletta, Oklahoma City, Oklahoma, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Houston Methodist Cancer Center, Houston, Texas, United States
The University of Texas M. D. Anderson Cancer Center, Houston, Texas, United States
Institut Jules Bordet, Bruxelles, , Belgium
Centre Antoine Lacassagne, Nice, Alpes Maritimes, France
Centre Paul Strauss, Strasbourg, Bas Rhin, France
Centre Georges François Leclerc, Dijon, Côte-d'Or, France
Institut Bergonié, Bordeaux, Gironde, France
Hôpital Saint-Louis, Paris Cedex 10, Paris, France
Centre Léon Bérard, Lyon, Rhone, France
Centre Hospitalier Lyon Sud, Pierre Benite cedex, Rhone, France
Institut Gustave Roussy, Villejuif, Val De Marne, France
Universitaetsklinikum Freiburg, Freiburg, Baden Wuerttemberg, Germany
Universitaetsklinikum Heidelberg, Heidelberg, Baden Wuerttemberg, Germany
Universitaetsklinikum Koeln, Koeln, Nordrhein Westfalen, Germany
The University of Hong Kong, Hong Kong, , Hong Kong
Hong Kong United Oncology Centre, Jordon, , Hong Kong
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori, Meldola, Forli - Cesena, Italy
Ospedale Sacro Cuore Don Calabria, Negrar, Verona, Italy
Azienda Ospedaliera Universitaria Careggi, Florence, , Italy
IEO Istituto Europeo di Oncologia, Milano, , Italy
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Trento), Verona, , Italy
Aichi Cancer Center Hospital, Nagoya-shi, Aichi-Ken, Japan
National Cancer Center Hospital East, Kashiwa-shi, Chiba-Ken, Japan
NHO Shikoku Cancer Center, Matsuyama-shi, Ehime-Ken, Japan
Hokkaido University Hospital, Sapporo-shi, Hokkaido, Japan
Osaka University Hospital, Suita-shi, Osaka-Fu, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo-To, Japan
Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seul, , Korea, Republic of
Samsung Medical Center, Seul, , Korea, Republic of
Antoni van Leeuwenhoek, Amsterdam, , Netherlands
Erasmus Medisch Centrum, Rotterdam, , Netherlands
Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos, Lisboa, , Portugal
Fundação Champalimaud, Lisboa, , Portugal
Centro Hospitalar do Porto, E.P.E - Hospital de Santo Antonio, Porto, , Portugal
National University Cancer Institute, Singapore, , Singapore
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario HM Madrid Sanchinarro, Madrid, , Spain
Clinica Universidad de Navarra, Pamplona, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Instituto Valenciano de Oncologia IVO, Valencia, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Karolinska universitetssjukhuset - Solna, Solna, , Sweden
Akademiska Sjukhuset, Uppsala, , Sweden
Acibadem Adana Hospital, Adana, , Turkey
Acibadem Maslak Hospital, Istanbul, , Turkey
Namik Kemal University, Tekirdağ, , Turkey
Sarah Cannon Research Institute UK, London, Greater London, United Kingdom
Contact Details
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