Spots Global Cancer Trial Database for Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib
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Trial Identification
Brief Title: Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib
Official Title: A Phase 4, Multicenter Study to Evaluate Discontinuation and Re-Treatment in Subjects With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib
Study ID: NCT04526704
Conditions
Interventions
Study Description
Brief Summary: This study is designed to evaluate the discontinuation/re-treatment of pexidartinib therapy in previously treated participants with tenosynovial giant cell tumor (TGCT).
Detailed Description: This multicenter study in previously pexidartinib-treated participants with TGCT will provide the Investigators and participants the option at Screening to either continue pexidartinib treatment (Treatment Continuation Cohort) or discontinue treatment with the possibility of re-initiating pexidartinib treatment (Treatment-Free/Re-Treatment Cohort).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Honor Health, Scottsdale, Arizona, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Washington University, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Oregon Health & Science University, Portland, Oregon, United States
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
Magyar Honvedseg Egeszsegugyi Kozpont, Budapest, , Hungary
Rizzoli-Istituto Ortopedico Rizzoli, Bologna, , Italy
Fondazione IRCC Istituto Nazionale dei Tumori, Milano, , Italy
Leiden University Medical Center (LUMC), Leiden, , Netherlands
Hospital Sant Pau, Barcelona, , Spain
Hospital Virgen del Rocio, Sevilla, , Spain
National Taiwan University Hospital, Taipei, , Taiwan
Contact Details
Name: Clinical Team Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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