A Phase I Multicenter Study of Continuous Oral Administration of Lonafarnib (SCH 66336) and Intravenous Gemcitabine in Patients With Advanced Cancer

作者：Wong Nan Soon; Meadows Kellen L; Rosen Lee S; Adjei Alex A; Kaufmann Scott H; Morse Michael A; Petros William P; Zhu Yali; Statkevich Paul; Cutler David L; Meyers Michael L; Hurwitz Herbert I^*

来源：Cancer Investigation, 2011, 29(9): 617-625.

DOI：10.3109/07357907.2011.621912

• Lonafarnib
• Gemcitabine
• Phase I
• Advanced cancer

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.

• 出版日期2011-11