ArticleEuropean journal of clinical pharmacology2024
Clinical pharmacokinetics and pharmacodynamics of ivosidenib in Chinese patients with relapsed or refractory IDH1-mutated acute myeloid leukemia.
Article in European journal of clinical pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04176393 (A Phase 1, Multicenter, Single-Arm Study Evaluating Pharmacokinetic, Pharmacodynamic, Safety, and Clinical Efficacy of Orally Administered Ivosidenib in Chinese Subjects With Relapsed or Refractory Acute Myeloid Leukemia With an IDH1 Mutation), which is not on this map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Phase 1, Multicenter, Single-Arm Study Evaluating Pharmacokinetic, Pharmacodynamic, Safety, and Clinical Efficacy of Orally Administered Ivosidenib in Chinese Subjects With Relapsed or Refractory Acute Myeloid Leukemia With an IDH1 Mutation
Who cites it
2 citing papers in PubMed, 1 citations in OpenAlex.
- Ivosidenib and Vorasidenib Decrease Intratumoral 2-Hydroxyglutarate and Total Choline Levels in Patients with Lower-Grade Glioma: An In Vivo MR Spectroscopy Study.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- Model-Informed Dosing Regimen of Sugemalimab for European Patients With Non-Small Cell Lung Cancer: Bridging From Asian Clinical Data.CPT: pharmacometrics & systems pharmacology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis study aimed to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of ivosidenib in Chinese patients with relapsed or refractory acute myeloid leukemia (R/R AML) carrying the mIDH1 mutation.
methodsA bridging study (NCT04176393) was conducted involving 29 Chinese patients who received a daily dose of ivosidenib 500 mg in 28-day cycles. Plasma concentrations of ivosidenib and D-2-hydroxyglutarate (2-HG) were measured before and after treatment. Non-compartmental analysis (NCA) was employed to evaluate the PK, and an established population pharmacokinetic (popPK) model developed from non-Chinese patients was externally validated.
resultsThe findings revealed comparable PD effects of ivosidenib in Chinese patients with mIDH1 R/R AML. After adjusting for concomitant drug effects, PK characteristics were similar between Chinese and non-Chinese patients. Furthermore, the popPK model offered additional insights into the possible causes of the apparent ethnic difference in PK exposure.
conclusionThe study indicates that ivosidenib can be used effectively in Chinese patients, and the observed ethnic differences in PK exposure can be explained by concomitant drug effects. The popPK model contributes to a better understanding and optimization of personalized dosing in Chinese patients with mIDH1 R/R AML.
Indexed as
Identifiers
What OpenQuestion holds
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.