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Clinical Trials in Italy / NCT05804045
Active, not recruiting Phase 3

Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)

NCT05804045 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2023-04-27
Last updated
2026-05-04

Condition(s) studied

Tenosynovial Giant Cell TumorPigmented Villonodular SynovitisGiant Cell Tumor of Tendon Sheath

Investigational drug(s) / intervention(s)

Pimicotinib(ABSK021) →Placebo

Pimicotinib(ABSK021): capsule

Placebo: capsule

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients should understand the study procedures and sign the informed consent form prior to screening. * 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: * Known allergy or hypersensitivity to any components of the investigational drug product. * 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.

Primary outcome measure(s)

Trial sites (40)

FacilityCityRegionStatus
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 Canada
Princess Margaret Cancer Center Toronto Canada
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
Shanghai General Hospital Shanghai Shanghai Municipality
The Second Hospital of Shanxi Medical University Taiyuan Shanxi
Xi'an Honghui Hospital Xi’an Shanxi
West China Hospital Sichuan University Chengdu Wuhan
The First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang
The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang
Zhejiang Cancer Hospital Hangzhou Zhejiang
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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05804045 on ClinicalTrials.gov ↗ ← All trials in Italy