A phase I multicenter study of continuous oral administration of lonafarnib (SCH 66336) and intravenous gemcitabine in patients with 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.
Wong, NS; Meadows, KL; Rosen, LS; Adjei, AA; Kaufmann, SH; Morse, MA; Petros, WP; Zhu, Y; Statkevich, P; Cutler, DL; Meyers, ML; Hurwitz, HI
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