Trial reportCancer chemotherapy and pharmacology2015
Pharmacokinetics of eribulin mesylate in cancer patients with normal and impaired renal function.
Trial report in Cancer chemotherapy and pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01418677 (An Open-Label Phase 1 Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function), which is not on this map. Cited by 10 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-Label Phase 1 Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function
Who cites it
10 citing papers in PubMed, 21 citations in OpenAlex.
- An intracerebral microdialysis study to determine the neuropharmacokinetics of eribulin in patients with metastatic or primary brain tumors.Cancer chemotherapy and pharmacology · 2024Trial
- Eribulin in breast cancer: Current insights and therapeutic perspectives.World journal of experimental medicine · 2024Review
- Effect of renal function on neutrophil decreases following eribulin administration.Cancer reports (Hoboken, N.J.) · 2020Article
- Phase 1 dose-finding and pharmacokinetic study of eribulin-liposomal formulation in patients with solid tumours.British journal of cancer · 2019Article
- Decreased Disposition of Anticancer Drugs Predominantly Eliminated via the Liver in Patients with Renal Failure.Current drug metabolism · 2019Review
- Review of Chromatographic Bioanalytical Assays for the Quantitative Determination of Marine-Derived Drugs for Cancer Treatment.Marine drugs · 2018Review
- Advances in the treatment of soft tissue sarcoma: focus on eribulin.Cancer management and research · 2018Review
- Efficacy of eribulin in breast cancer: a short report on the emerging new data.OncoTargets and therapy · 2017Review
- A phase I pharmacokinetic and safety study of cabazitaxel in adult cancer patients with normal and impaired renal function.Cancer chemotherapy and pharmacology · 2016Article
- Risk Factors for Eribulin-induced Severe Neutropenia in Patients With Recurrent Breast Cancer.In vivo (Athens, Greece)Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 1 country.
Funding
Abstract
purposeTo evaluate the effect of renal impairment on eribulin mesylate pharmacokinetics following a single dose in adults with advanced solid tumors.
methodsPatients were grouped by renal function: moderate impairment (creatinine clearance [CrCl] 30-50 mL/min), severe impairment (CrCl 15-29 mL/min), or normal (CrCl ≥80 mL/min). During each 21-day cycle, eribulin mesylate doses (days 1 and 8) were administered intravenously: moderate, 1.1 mg/m(2) (except cycle 1 day 1, 1.4 mg/m(2)); severe, 0.7 mg/m(2); normal, 1.4 mg/m(2).
resultsNineteen patients were enrolled (normal, n = 6; moderate, n = 7; severe, n = 6). Renal impairment was associated with an increased mean dose-normalized area under the concentration-time curve (ratios for moderate/normal and severe/normal: 1.49; 90 % confidence interval [CI] 0.9, 2.45). CrCl and renal function correlated positively, with a numerically small slope (0.0184; 90 % CI -0.00254, 0.0394). A simulated dose reduction to eribulin 1.1 mg/m(2) in patients with moderate or severe renal impairment achieved the same exposure as 1.4 mg/m(2) in those with normal renal function. All groups had similar toxicity profiles, with no unexpected adverse events.
conclusionsRenal impairment decreased eribulin clearance and increased exposure. Pharmacokinetic evaluation supports an eribulin dose reduction to 1.1 mg/m(2) in patients with moderate or severe renal impairment. CLINICALTRIALS. GOV IDENTIFIER: NCT01418677.
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