Spots Global Cancer Trial Database for Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)
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Trial Identification
Brief Title: Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)
Official Title: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study of ABSK021 to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor
Study ID: NCT05804045
Study Description
Brief Summary: The goal of this clinical trial is to assess the efficacy and safety of Pimicotinib (ABSK021) in patients with Tenosynovial Giant Cell Tumor (TGCT). The main questions it aims to answer are: * Whether the Pimicotinib(ABSK021) works well in patients with TGCT. * Whether the Pimicotinib(ABSK021) is safe in patients with TGCT. Participants will be asked to complete the study procedures: * Receive the administration of Pimicotinib(ABSK021) or placebo (a placebo is a look-alike substance that contains no active drug) about 24 weeks in study part 1. * Receive the administration of Pimicotinib(ABSK021) about 24 weeks in study part 2. * Receive the administration of Pimicotinib(ABSK021) till study end in study part 3. * Complete the study procedures speficied in the protocol, which is guided by researchers.
Detailed Description: This study consists of part 1 and part 2. Part 1 is a double-blind phase, eligible patients will be randomized to Pimicotinib(ABSK021) treatment group or matching placebo group and will receive Pimicotinib(ABSK021) or matching placebo until completion of Part 1. Part 2 is an open-label treatment phase, and all patients entering this phase will receive open-label Pimicotinib(ABSK021) until completion of 24 weeks of dosing or withdrawal from the study. Part 3 is an open-label extension treatment phase, and patients who completed the part 2 and continuted to be eligible, will go to the Part 3. Patients will receive the open-label Pimicotinib(ABSK021) until all patients withdraw from the study, or the sponsor decides to terminate the study, whichever occurs first.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Precision NextGen Oncology, Beverly Hills, California, United States
Henry Ford Health System, Detroit, Michigan, United States
The Cleveland Clinic Foundation, Cleveland, Ohio, United States
The Ohio State University, Columbus, Ohio, United States
The University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
McGill University Health Center, Montréal, , Canada
Princess Margaret Cancer Center, Toronto, , Canada
The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
Peking University People's Hospital, Beijing, Beijing, China
The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, China
Henan Cancer Hospital, Zhengzhou, Henan, China
The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture, Enshi, Hubei, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Hunan Provincial People's Hospital, Changsha, Hunan, China
The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
Nanjing Drum Tower hospital, Nanjing, Jiangsu, China
Liaoning Cancer Hospital&Institute, Shenyang, Liaoning, China
Weifang People's Hospital, Weifang, Shandong, China
Shanghai General Hospital, Shanghai, Shanghai, China
The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China
Xi'an Honghui Hospital, Xi'an, Shanxi, China
West China Hospital Sichuan University, Chengdu, Wuhan, China
The First Affiliated Hospital of Xinjiang Medical University, Ürümqi, Xinjiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Beijing Jishuitan Hospital, Beijing, , China
IRCCS Istituto Ortopedico Rizzoli, Bologna, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Ospedale di Prato, Prato, , Italy
Leiden University Medical Center, Leiden, , Netherlands
Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, , Poland
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Fundacion Jimenez Diaz, Madrid, , Spain
Contact Details
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