國家衛生研究院 NHRI:Item 3990099045/13095
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    题名: Phase I dose-escalation study of SCB01A, a microtubule inhibitor with vascular disrupting activity, in patients with advanced solid tumors
    作者: Shiah, HS;Chiang, NJ;Lin, CC;Yen, CJ;Tsai, HJ;Wu, SY;Su, WC;Chang, KY;Wang, CC;Chang, JY;Chen, LT
    贡献者: National Institute of Cancer Research
    摘要: LESSONS LEARNED: SCB01A is a novel microtubule inhibitor with vascular disrupting activity. This first-in-human study demonstrated SCB01A safety, pharmacokinetics, and preliminary antitumor activity. SCB01A is safe and well-tolerated in patients with advanced solid malignancies with manageable neurotoxicity. BACKGROUND: SCB01A, a novel microtubule inhibitor, has vascular disrupting activity (VDA). METHODS: In this phase I dose-escalation and extension study, patients with advanced solid tumors were administered intravenous SCB01A infusions for 3 hours once every 21 days. Rapid titration and a 3+3 design escalated the dose from 2 mg/m(2) to the maximum tolerated dose (MTD) based on dose-limiting toxicity (DLT). SCB01A-induced cellular neurotoxicity was evaluated in dorsal root ganglion cells. The primary endpoint was MTD. Safety, pharmacokinetics (PK), and tumor response were secondary endpoints. RESULTS: Treatment-related adverse events included anemia, nausea, vomiting, fatigue, fever, and peripheral sensorimotor neuropathy. DLTs included grade (G)4 elevated creatine phosphokinase (CPK) in the 4 mg/m(2) cohort; G3 gastric hemorrhage in the 6.5 mg/m(2) cohort; G2 thromboembolic event in the 24 mg/m(2) cohort; G3 peripheral sensorimotor neuropathy, G3 elevated aspartate aminotransferase, and G3 hypertension in the 32 mg/m(2) cohort. The MTD was 24 mg/m(2) , and average half-life was ~2.5 hours. The area under the curve-dose response relationship was linear. Nineteen subjects were stable after two cycles. The longest treatment lasted 24 cycles. SCB01A-induced neurotoxicity was reversible in vitro. CONCLUSION: The MTD of SCB01A was 24 mg/m(2) every 21 days; it is safe and tolerable in patients with solid tumors.
    日期: 2021-04
    關聯: Oncologist. 2021 Apr;26(4):e567-e579.
    Link to: http://dx.doi.org/10.1002/onco.13612
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1083-7159&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000599729500001
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85097816159
    显示于类别:[陳立宗] 期刊論文
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