A phase i multicenter study of continuous oral administration of lonafarnib (SCH 66336) and intravenous gemcitabine in patients with advanced cancer

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

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

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 Tmax 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.

Original languageEnglish (US)
Pages (from-to)617-625
Number of pages9
JournalCancer Investigation
Volume29
Issue number9
DOIs
StatePublished - Nov 2011

Keywords

  • Advanced cancer
  • Gemcitabine
  • Lonafarnib
  • Phase I

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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