Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)
Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath
About this trial
This is an interventional treatment trial for Tenosynovial Giant Cell Tumor
Eligibility Criteria
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.
Sites / Locations
- Precision NextGen OncologyRecruiting
- The Cleveland Clinic FoundationRecruiting
- The University of Texas M.D. Anderson Cancer CenterRecruiting
- Fred Hutchinson Cancer CenterRecruiting
- The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
- Peking University People's HospitalRecruiting
- The First Affiliated Hospital of Fujian Medical UniversityRecruiting
- Guangdong Provincial People's HospitalRecruiting
- The First Affiliated Hospital of Jinan UniversityRecruiting
- The First Affiliated Hospital, Sun Yat-sen UniversityRecruiting
- The Affiliated Hospital of Guizhou Medical UniversityRecruiting
- Henan Cancer HospitalRecruiting
- The Central Hospital of Enshi Tujia and Miao Autonomous PrefectureRecruiting
- Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
- Hunan Provincial People's HospitalRecruiting
- The Second Xiangya Hospital of Central South UniversityRecruiting
- Nanjing Drum Tower hospitalRecruiting
- Liaoning Cancer Hospital&InstituteRecruiting
- Weifang People's HospitalRecruiting
- Shanghai General HospitalRecruiting
- The Second Hospital of Shanxi Medical UniversityRecruiting
- Xi'an Honghui HospitalRecruiting
- West China Hospital Sichuan UniversityRecruiting
- The First Affiliated Hospital of Xinjiang Medical UniversityRecruiting
- The Second Affiliated Hospital Zhejiang University School of MedicineRecruiting
- Zhejiang Cancer HospitalRecruiting
- Beijing Jishuitan HospitalRecruiting
- Fundacion Jimenez DiazRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Part 1/Part 2- Pimicotinib(ABSK021)/ Pimicotinib(ABSK021)
Part 1/Part 2- Placebo/ 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.
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.