CTIS2024-513624-42-00进行中（未招募）1 期
A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients with Tenosynovial Giant Cell Tumor (MOTION) - DCC-3014-03-001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 123
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Male or female participants =18 years of age, Participants of reproductive potential must: a. Have a negative serum beta-human chorionic gonadotropin (ß-hCG) pregnancy test at screening (female participants). b. Agree to follow the contraception requirements outlined in the protocol, The participant is capable of understanding and complying with the protocol and has signed the informed consent form (ICF). A signed ICF must be obtained before any study-specific procedures are performed., Willing and able to complete the PRO assessments on an electronic device, Histologically confirmed diagnosis of TGCT (formerly known as pigmented villonodular synovitis [PVNS] or giant cell tumor of the tendon sheath [GCT-TS]). Tumor biopsy to confirm TGCT diagnosis will be required if no histology/pathology is available. a. Participants should have TGCT in a single joint and must have TGCT in joints where ROM can be assessed, Disease for which surgical resection will potentially cause worsening functional limitation or severe morbidity as judged by surgical consultation or a multidisciplinary tumor board, Symptomatic disease with at least moderate pain or at least moderate stiffness (defined as a score of 4 or more, with 10 describing the worst condition) within the screening period and documented in the medical record, Participant should complete 14 consecutive days of questionnaires during the screening period and must meet minimum requirements outlined in Protocol Table 4, An analgesic regimen, if used, needs to be stable( ie, no change in dose) as judged by the Investigator for at least 2 weeks prior to the first dose of study drug, Measurable disease per RECIST v1.1 with at least one lesion having a minimum size of 2 cm as assessed from magnetic resonance imaging (MRI) scans by a central radiologist, Adequate organ function and bone marrow reserve as indicated by the following laboratory assessments performed within 21 days prior to the first dose of study drug: a. Bone marrow function: absolute neutrophil count (ANC) =1500/µL; hemoglobin =10 g/dL; platelet count =lower limit of normal (LLN). b. Hepatic function: total serum bilirubin =upper limit of normal (ULN); serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =ULN. c. Renal function: creatinine clearance =50 mL/min based either on urine collection or Cockcroft-Gault estimation. d. Electrolytes =LLN for: potassium, magnesium, and calcium, Able to take oral medication
排除标准
- •Previous use of systemic therapy (investigational or approved) targeting CSF1 or CSF1R including vimseltinib; previous therapy with imatinib and nilotinib is allowed, Known active human immunodeficiency virus (HIV), acute or chronic hepatitis B, acute or chronic hepatitis C, or known active mycobacterium tuberculosis infection, If female, the participant is pregnant or breastfeeding, Known allergy or hypersensitivity to any component of the study drug, Contraindication to MRI, Treatment for TGCT, including investigational therapy, during the screening period. NOTE: Participants may not be part of an ongoing or have prior participation in a non TGCT investigational drug study within 30 days of screening. Ongoing participation in a noninterventional study (including observational studies) is permitted, Known metastatic TGCT or other active cancer that requires concurrent treatment (exceptions will be considered on a case-by-case basis depending on tumor type, stage, location, planned treatment, and expected recovery after discussion and approval by Sponsor), Baseline prolongation of the QT interval corrected by Fridericia's formula (QTcF) based on repeated demonstration of QTcF >450 ms in males or >470 ms in females or history of long QT syndrome, Receive concurrent treatment with any prohibited medications • Acetaminophen usage exceeding 3 g/day • Proton-pump inhibitors taken within 4 days prior to the first dose of study drug • Medications that are breast cancer resistance protein (BCRP) or organic cation transporter 2 (OCT2) substrates taken within at least 4 days or 5×half-life (whichever is longer) prior to the first dose of study drug • Medications with a known risk of prolonging the QT interval within at least 14 days or 5×half-life (whichever is longer) prior to the first dose of study drug (see Appendix 1) • Prophylactic use of myeloid growth factors (eg, granulocyte colonystimulating factor [G-CSF], granulocyte macrophage-colony-stimulating factor [GM-CSF]), Major surgery within 14 days of the first dose of study drug; following major surgeries >14 days prior to the first dose of study drug, all surgical wounds must be healed and free of infection or dehiscence, Any clinically significant comorbidities, such as significant concomitant arthropathy not related to TGCT in the affected joint, or any other serious medical or psychiatric condition(s), known current alcohol abuse, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the participant to safety risks, Active liver or biliary disease including non-alcoholic steatohepatitis (NASH), or cirrhosis, Malabsorption syndrome or other illness that could affect oral absorption as judged by the Investigator
研究者
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