Phase I study of oral lenalidomide in patients with refractory metastatic cancer

William L. Dahut, Jeanny B. Aragon-Ching, Sukyung Woo, Tanyifor M. Tohnya, James L. Gulley, Philip M. Arlen, John J. Wright, Jurgen Ventiz, William D. Figg

Research output: Contribution to journalArticlepeer-review

51 Scopus citations


Objectives of this study were to determine the maximum tolerated dose and to characterize the side effect profile and pharmacokinetics of lenalidomide in patients with advanced refractory solid tumors. Patients were treated on a modified Fibronacci dose escalation scheme with an oral daily dose of lenalidomide. A total of 45 patients with 8 different tumor types were accrued. Doses administered included 5, 10, and 20 mg continuous daily doses, every 28 days (n = 15), later modified to intermittent doses of 15, 20, 25, 30, 35, and 40 mg, with a 21 days-on and 7 days-off schedule, due to observed side effects. Lenalidomide exhibited a linear pharmacokinetics over a wide range of doses with the mean half-life of 3.9 hours. The renal function affected lenalidomide clearance, resulting in 50% reduction in patients with mild renal impairment compared with patients with normal function (CL/F= 243 mL/ min). Stable disease was documented in 12 of 44 evalu-able patients, of whom 9 patients had prostate cancer. Most frequent grade 1 and 2 toxicities included fatigue, nausea, pruritus/rash, neutropenia, and neuropathy. Grade 3/4 events were predominantly hematologic. Lenalidomide was well tolerated up to a 35-mg/d intermittent dosing schedule at doses higher than previously indicated for hematologic malignancies.

Original languageEnglish
Pages (from-to)650-660
Number of pages11
JournalJournal of Clinical Pharmacology
Issue number6
StatePublished - Jun 2009
Externally publishedYes


  • Androgen-independent prostate cancer
  • Angio-genesis
  • CC-5013
  • Lenalidomide
  • Refractory cancer


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