Trial reportJournal of clinical pharmacology2015
Quantification of the impact of enzyme-inducing antiepileptic drugs on irinotecan pharmacokinetics and SN-38 exposure.
Trial report in Journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.
- Management of epilepsy in brain tumors.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2019Guideline
- <p>Unveiling sex differences in pancreatic ductal adenocarcinoma: Current evidence and future directions (Review)</p>.International journal of oncology · 2026Review
- Multi-drug pharmacotyping improves therapy prediction in pancreatic cancer organoids.Cancer cell international · 2025Article
- Sex as a Biological Variable in Early-Phase Oncology Clinical Trials: Enhancing the Path to Personalised Medicine.Heliyon · 2024Review
- Population pharmacokinetics of intraperitoneal irinotecan and SN-38 in patients with peritoneal metastases from colorectal origin.CPT: pharmacometrics & systems pharmacology · 2024Article
- Population pharmacokinetic analysis of TQ-B3203 following intravenous administration of TQ-B3203 liposome injection in Chinese patients with advanced solid tumors.Frontiers in pharmacology · 2023Article
- Role of sex on psychological distress, quality of life, and coping of patients with advanced colorectal and non-colorectal cancer.World journal of gastrointestinal oncology · 2022Article
- Prediction of Drug-Drug Interaction Between Dabrafenib and Irinotecan via UGT1A1-Mediated Glucuronidation.European journal of drug metabolism and pharmacokinetics · 2022Article
- Gender Differences in Patients with Metastatic Pancreatic Cancer Who Received FOLFIRINOX.Journal of personalized medicine · 2021Article
- Article
- Population pharmacokinetic model of irinotecan and its metabolites in patients with metastatic colorectal cancer.European journal of clinical pharmacology · 2019Article
- Individualization of Irinotecan Treatment: A Review of Pharmacokinetics, Pharmacodynamics, and Pharmacogenetics.Clinical pharmacokinetics · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 1 country.
Funding
Abstract
The population pharmacokinetic model reported here was developed using data from 2 phase 2 trials of irinotecan for treatment of malignant glioma to quantify the impact of concomitant therapy with enzyme-inducing antiepileptic drugs (EIAEDs) on irinotecan pharmacokinetics. Patients received weekly irinotecan doses of 100 to 400 mg/m(2) , and plasma samples were collected and analyzed for irinotecan and its APC, SN-38, and SN-38G metabolites. Nonlinear mixed-effects modeling was employed for population pharmacokinetic analysis. Concomitant therapy with phenytoin, phenobarbital, or carbamazepine increased the clearances of irinotecan, SN-38, and SN-38G but not APC. SN-38 clearance was 2-fold higher with concomitant EIAED use, resulting in 40% lower SN-38 exposure. Evaluation of additional covariates revealed no clinically relevant effects of sex or concomitant corticosteroid use. The population pharmacokinetic model suggests that a 1.7-fold increase in irinotecan dose may compensate for decreases in SN-38 exposure in the presence of concomitant EIAEDs. Although slightly more conservative, this dose adjustment is consistent with those recommended based on increases in the maximally tolerated dose for malignant glioma patients receiving EIAEDs and may be an appropriate starting point for further investigation when extrapolating to other cancer types or alternative regimens.
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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.