一项评估 lonafarnib（SCH 66336）连续口服联合静脉注射吉西他滨治疗晚期癌症患者的 I 期多中心研究。
A phase I multicenter study of continuous oral administration of lonafarnib (SCH 66336) and intravenous gemcitabine in patients with advanced cancer.
机构信息
Duke University Medical Center, Durham, North Carolina, USA.
出版信息
Cancer Invest. 2011 Nov;29(9):617-25. doi: 10.3109/07357907.2011.621912.
Abstract
We conducted a phase I study to assess safety, pharmacokinetics, pharmacodynamics, and activity of lonafarnib plus gemcitabine. Subjects received oral lonafarnib twice daily and gemcitabine on days 1, 8, and 15 every 28 days; multiple dose levels were explored. Lonafarnib had no apparent effect on gemcitabine PK. Mean lonafarnib half-life ranged from 4 to 7 hr; median T(max) values ranged from 4 to 8 hr. Two patients had partial response; seven patients had stable disease at least 6 months. Oral lonafarnib at 150 mg a.m./100 mg p.m. plus gemcitabine at 1,000 mg/m(2) is the maximum tolerated dose with acceptable safety and tolerability.
摘要
我们进行了一项 I 期研究，以评估 lonafarnib 联合吉西他滨的安全性、药代动力学、药效学和活性。受试者每天口服 lonafarnib 两次，吉西他滨在第 1、8 和 15 天，每 28 天一次；探索了多个剂量水平。Lonafarnib 对吉西他滨 PK 无明显影响。Lonafarnib 的平均半衰期范围为 4 至 7 小时；中位数 T(max)值范围为 4 至 8 小时。两名患者有部分缓解；七名患者疾病稳定至少 6 个月。Lonafarnib 每天上午 150 毫克/下午 100 毫克联合吉西他滨 1000 毫克/平方米是最大耐受剂量，具有可接受的安全性和耐受性。
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