Trial reportCPT: pharmacometrics & systems pharmacology2020
Development and Application of a Mechanistic Population Modeling Approach to Describe Abemaciclib Pharmacokinetics.
Trial report in CPT: pharmacometrics & systems pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 13 citations in OpenAlex.
- A Signal-Finding Study of Abemaciclib in Heavily Pretreated Patients with Metastatic Castration-Resistant Prostate Cancer: Results from CYCLONE 1.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024Trial
- Abemaciclib does not increase the corrected QT interval in healthy participants.Clinical and translational science · 2023Trial
- Japanese subgroup analysis of the phase 3 MONARCH 3 study of abemaciclib as initial therapy for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer.Breast cancer (Tokyo, Japan) · 2022Trial
- Abemaciclib in combination with endocrine therapy for East Asian patients with HR+, HER2- advanced breast cancer: MONARCH 2 & 3 trials.Cancer science · 2021Trial
- Creatinine-Cystatin C Discrepancy and Renal Transporter Polymorphisms in Japanese Patients with Breast Cancer Receiving Abemaciclib.Clinical pharmacology and therapeutics · 2026Article
- Article
- Longitudinal Tumor Size and Survival Modeling for Exposure-Response Analysis of Drugs with Frequent Dose Reductions: Dose Justification of Abemaciclib in Patients with Metastatic Breast Cancer.Clinical pharmacology and therapeutics · 2026Article
- Exploring neuropharmacokinetics: mechanisms, models, and clinical implications.Encephalitis (Seoul, Korea) · 2025Article
- Review
- Assay for the quantification of abemaciclib, its metabolites, and olaparib in human plasma by liquid chromatography-tandem mass spectrometry.Journal of pharmaceutical and biomedical analysis · 2025Article
- Clofazimine pharmacokinetics in HIV-infected adults with diarrhea: Implications of diarrheal disease on absorption of orally administered therapeutics.CPT: pharmacometrics & systems pharmacology · 2024Article
- Abemaciclib pharmacology and interactions in the treatment of HR+/HER2- breast cancer: a critical review.Therapeutic advances in drug safety · 2024Review
- Abemaciclib in combination with pembrolizumab for HR+, HER2- metastatic breast cancer: Phase 1b study.NPJ breast cancer · 2022Article
Corrections and comments
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Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Abemaciclib is an oral anticancer drug that inhibits cyclin dependent kinases 4 and 6 and is metabolized by cytochrome P450 3A in the intestines and liver to active metabolites. The objectives were (1) to develop a mechanistic model to characterize the pharmacokinetics (PK) of the active moieties and investigate the effect of patient factors and (2) apply the model to dat from two phase III breast cancer trials of abemaciclib in combination with endocrine therapy. To develop the model, data from seven phase I studies and two phase II studies including 421 patients with cancer and 65 healthy individuals were pooled for nonlinear mixed effects modeling. The PK was similar between patients and healthy subjects, and the effects of diarrhea, formulation, race, and patient covariates on exposure were negligible. Application of the model confirmed its predictive performance and that abemaciclib PK did not change when coadministered with endocrine therapy.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.