NL-OMON56439已完成3 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) - MOTIO
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
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 99（—）
入选标准
- •Participants must meet all of the following criteria to be eligible to enroll
- •in the study:
- •1. Male or female participants >=18 years of age
- •2. 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 assessments can be assessed
- •3. Disease for which surgical resection will potentially cause worsening
- •functional limitation or severe morbidity as judged by surgical consultation or
- •a multidisciplinary tumor board
- •4. 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
- •5. Participants should complete 14 consecutive days of questionnaires during
- •the screening period and must meet minimum requirements outlined in Table 4
- •6. 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
- •7. 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
- •8. 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
- •9. Able to take oral medication
- •10. Participants of reproductive potential must:
- •a. Have a negative serum beta human chorionic gonadotropin (β hCG) pregnancy
- •test at screening (female participants)
- •b. Agree to follow the contraception requirements outlined in the protocol
- •11. 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
- •12. Willing and able to complete the PRO assessments on an electronic device
排除标准
- •Participants meeting any of the following criteria will be excluded from the
- •1. Previous use of systemic therapy (investigational or approved) targeting
- •CSF1 or CSF1R including vimseltinib; previous therapy with imatinib and
- •nilotinib is allowed
- •2. 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
- •3. 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)
- •4. 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
- •5. 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
- •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
- •colony-stimulating factor [G CSF], granulocyte macrophage-colony-stimulating
- •factor [GM-CSF])
- •6. 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
- •7. 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
- •8. Active liver or biliary disease including nonalcoholic steatohepatitis
- •(NASH) or cirrhosis
- •9. Malabsorption syndrome or other illness that could affect oral absorption
- •as judged by the Investigator
- •10. Known active human immunodeficiency virus (HIV), acute or chronic hepatitis
- •B, acute or chronic hepatitis C, or known active mycobacterium tuberculosis
- •11. If female, the participant is pregnant or breastfeeding
- •12. Known allergy or hypersensitivity to any component of the study drug
- •13. Contraindication to MRI
研究者
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