Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)
NCT ID: NCT05804045
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
90 participants
INTERVENTIONAL
2023-04-27
2028-06-30
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part 1/Part 2/Part 3- Pimicotinib(ABSK021)/ Pimicotinib(ABSK021)
Participants receive the blinded treatment of ABSK021 for 24 weeks in Part 1 and continue on the open-label Pimicotinib(ABSK021) in Part 2 and Part 3.
Pimicotinib(ABSK021)
capsule
Part 1- Placebo/ Pimicotinib(ABSK021)
Participants receive the blinded treatment of matching placebo for 24 weeks in Part 1 and have option to receive the open-label Pimicotinib(ABSK021) in Part 2.
Pimicotinib(ABSK021)
capsule
Placebo
capsule
Interventions
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Pimicotinib(ABSK021)
capsule
Placebo
capsule
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years.
* A histologically confirmed TGCT with unresectable.
* Measurable disease as defined by RECIST 1.1, and with at least one lesion of ≥ 2 cm.
* Stable prescription of analgesic regimen for patients with an analgesic need.
* Participants should complete stiffness and pain scales during the screening period, and symptomatic disease because of active TGCT should meet minimum requirements as outlined in study protocol.
* ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 or 1.
* Adequate organ function and bone marrow function.
Exclusion Criteria
* Previous treatment with highly selective inhibitors targeting CSF-1/CSF-1R. Previous therapy with imatinib and nilotinib is allowed.
* Known additional malignancy that required active treatment and may affect the patient's participation in the study or affect the outcome of the study as assessed by the Investigator.
* Known metastatic TGCT.
* Significant concomitant arthropathy in the affected joint, serious disease, uncontrolled infection.
* Known MRI contraindications.
* Has factors that significantly affected the absorption of oral drug.
* Major surgery or previous anti-tumor therapy for TGCT within 4 weeks prior to randomization.
* Concomitant use of strong CYP inhibitors or inducers as outlined in study protocol.
* Impaired cardiac function or clinically significant cardiac disease.
* Known active human immunodeficiency virus, active hepatitis B, active hepatitis C, or known active tuberculosis.
* Known active liver or biliary disease, or other diseases that may lead to abnormal liver function test results during the study.
* Pregnant or lactating women.
* Childbearing potential males or non-surgically sterilized female patients must agree to use effective methods of contraception during the study.
* Any other clinically significant comorbidities, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.
18 Years
ALL
No
Sponsors
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Abbisko Therapeutics Co, Ltd
INDUSTRY
Responsible Party
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Locations
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Precision NextGen Oncology
Beverly Hills, California, United States
Duke University Medical Center
Durham, California, United States
Henry Ford Health System
Detroit, Michigan, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 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
Montreal, , 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 Municipality, 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 Municipality, 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
Milan, , 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
Countries
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References
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Niu X, Ravi V, Shan B, Guo Q, Shi H, Zou Q, Gelderblom H. MANEUVER: A Phase III study of pimicotinib to assess efficacy and safety in tenosynovial giant cell tumor patients. Future Oncol. 2024 Sep 17:1-8. doi: 10.1080/14796694.2024.2396227. Online ahead of print.
Other Identifiers
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ABSK021-301
Identifier Type: -
Identifier Source: org_study_id
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