Phase I study of oral lenalidomide in patients with refractory metastatic cancer
Open accessAbstract
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 evaluable 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.
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The plasma concentration of thalidomide in humans is unlikely to exceed 10 μM.
“The plasma concentration of thalidomide in humans is, however, unlikely to exceed 10 µM (Bai et al., 2013; Dahut et al., 2009)”
From Thalidomide promotes degradation of SALL4, a transcription factor implicated in Duane Radial Ray syndrome (2018) · cites this paper as Dahut et al., 2009
The Results (Pharmacokinetics; page unavailable) report plasma concentrations of lenalidomide, not thalidomide. The Discussion compares their pharmacokinetics but gives no thalidomide plasma-concentration limit. Searches for thalidomide plasma concentration, Cmax, and 10 μM found no passage establishing the claimed threshold. (LLM, conf=0.76)
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- Authors
- Dahut, W. L., Aragon‐Ching, J. B., Woo, S., Tohnya, T. M., Gulley, J. L., Arlen, P. M., Wright, J. J., Ventiz, J., & Figg, W. D.
- Affiliations
- National Cancer Institute (US)
- Virginia Commonwealth University (US)
- Corresponding author
- Figg, William D.
- Venue
- The Journal of Clinical Pharmacology
- Publisher
- Wiley
- Published
- 2009-06
- Volume
- 49
- Issue
- 6
- Pages
- 650-660
- ISSN
- 0021-9754 (ISSN-L)
- 0091-2700
- 1552-4604
- PMC
- PMC2808857
- OpenAlex
- W2038048162
- Cited by
- 56
- References
- 27
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 1 · 2023: 1 · 2022: 2 · 2021: 1 · 2018: 2 · 2017: 2 · 2016: 3 · 2015: 2 · 2014: 2 · 2013: 5 · 2012: 12
- FWCI
- 4.30
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Journal of Clinical Pharmacology (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health
- National Cancer Institute (Z01SC006538)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein Degradation and Inhibitors
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
- Keywords
- lenalidomide, refractory solid tumors, metastatic cancer, maximum tolerated dose, pharmacokinetics, renal dysfunction, drug clearance, intermittent dosing, adverse events, hematologic toxicity, prostate cancer
- MeSH terms
- Lenalidomide, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Female, Humans, Male, Middle Aged, Neoplasm Metastasis, Neoplasms, Thalidomide
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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