Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER) (NCT05804045)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Precision NextGen Oncology — Beverly Hills, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (40 Sites)
Showing the first 25 of 40 sites.
- Precision NextGen Oncology — Beverly Hills, California
- Duke University Medical Center — Durham, California
- Henry Ford Health System — Detroit, Michigan
- Roswell Park Comprehensive Cancer Center — Buffalo, New York
- The Cleveland Clinic Foundation — Cleveland, Ohio
- The Ohio State University — Columbus, Ohio
- The University of Texas M.D. Anderson Cancer Center — Houston, Texas
- Fred Hutchinson Cancer Center — Seattle, Washington
- McGill University Health Center — Montreal,
- Princess Margaret Cancer Center — Toronto,
- The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui
- Peking University People's Hospital — Beijing, Beijing Municipality
- The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong
- The First Affiliated Hospital of Jinan University — Guangzhou, Guangdong
- The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong
- The Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou
- Henan Cancer Hospital — Zhengzhou, Henan
- The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture — Enshi, Hubei
- Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei
- Hunan Provincial People's Hospital — Changsha, Hunan
- The Second Xiangya Hospital of Central South University — Changsha, Hunan
- Nanjing Drum Tower hospital — Nanjing, Jiangsu
- Liaoning Cancer Hospital&Institute — Shenyang, Liaoning
- Weifang People's Hospital — Weifang, Shandong
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Tenosynovial Giant Cell Tumor
- Study of Vimseltinib for Tenosynovial Giant Cell Tumor — Duarte, California
- MOVE: Tenosynovial Giant Cell Tumor (TGCT) Real-World Participant Experience With Vimseltinib — Wilmington, North Carolina
Explore by condition: All Tenosynovial Giant Cell Tumor clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.