First-in-human phase I study of SOR-C13, a TRPV6 calcium channel inhibitor, in patients with advanced solid tumors
作者: S. FuH. HirteS. WelchT. T. IlenchukT. LutesC. RiceN. FieldsA. NemetD. DugourdS. Piha-PaulV. SubbiahL. LiuJ. GongD. HongJ. M. Stewart
作者单位: 1M. D. Anderson Cancer Center
2Juravinski Cancer Centre
3London Health Sciences Centre
4Soricimed Biopharma Inc.
5Sagecon Inc.
6CLINSIG Research Consulting Inc.
刊名: Investigational New Drugs, 2017, Vol.35 (3), pp.324-333
来源数据库: Springer Journal
DOI: 10.1007/s10637-017-0438-z
关键词: TRPV6Sor-C13Calcium channelOncology
英文摘要: Introduction This was an open-label, dose escalation (3 + 3 design), Phase I study of SOR-C13 in patients with advanced tumors of epithelial origin. Primary objectives were to assess safety/tolerability and pharmacokinetics. Secondary goals were to assess pharmacodynamics and efficacy of SOR-C13. Methods SOR-C13 was administered IV QD on days 1–3 and 8–10 of a 21-day cycle. Doses were 2.75 and 5.5 mg/kg (20-min infusion) and 1.375, 2.75, 4.13 and 6.2 mg/kg (90-min infusion). Toxicity was assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Dose limiting toxicity (DLT) was assessed within the first treatment cycle. Tumors were evaluated, using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, after two cycles. Results...
原始语种摘要: Introduction This was an open-label, dose escalation (3 + 3 design), Phase I study of SOR-C13 in patients with advanced tumors of epithelial origin. Primary objectives were to assess safety/tolerability and pharmacokinetics. Secondary goals were to assess pharmacodynamics and efficacy of SOR-C13. Methods SOR-C13 was administered IV QD on days 1–3 and 8–10 of a 21-day cycle. Doses were 2.75 and 5.5 mg/kg (20-min infusion) and 1.375, 2.75, 4.13 and 6.2 mg/kg (90-min infusion). Toxicity was assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Dose limiting toxicity (DLT) was assessed within the first treatment cycle. Tumors were evaluated, using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, after two cycles. Results...
全文获取路径: Springer  (合作)
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影响因子:3.498 (2012)

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关键词翻译
关键词翻译
  • SOR Serial Output Register
  • events 定时
  • hypocalcemia 血钙过少
  • infusion 浸剂
  • fibrillation 原纤维化
  • hypokalemia 血钾过少
  • escalation 逐步升级
  • channel 槽水道
  • asymptomatic 无症状的
  • antitumor 抗癌的