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Impact of cytochrome P450 3A4 inducer and inhibitor on the pharmacokinetics of trabectedin in patients with advanced malignancies: open-label, multicenter studies.

Author: BernardApexa, DirixLuc, HerremansCatherine, KeungChi, KhokharNushmia Z, KnoblauchRoland, MachielsJean-Pascal, ParekhTrilok V, PhelpsCharles, SharmaSunil, StaddonArthur

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

Coadministration of rifampin or ketoconazole alters the pharmacokinetics of trabectedin. While no new safety signals were observed, coadministration with strong CYP3A4 inhibitors or inducers should be avoided if possible. If coadministration with a CYP3A4 inhibitor is required, close monitoring for toxicities is recommended.
Paper Details　
Original Abstract of the Article :
PURPOSE: To evaluate the pharmacokinetics, safety and survival of trabectedin, metabolized primarily by cytochrome P450 (CYP)3A4 enzyme, when coadministered with rifampin (CYP3A4 inducer) or ketoconazole (CYP3A4 inhibitor) in adult patients with advanced solid tumors. METHODS: Two phase 1/2a, 2-way...See full text at original site
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引用元：
https://doi.org/10.1007/s00280-014-2554-1

データ提供：米国国立医学図書館（NLM）

The Impact of Drug Interactions on Trabectedin: A Pharmacokinetic Study

In the complex world of pharmacology, drug interactions are a critical concern. This research delved into the pharmacokinetic interactions of trabectedin, a cancer drug metabolized by the CYP3A4 enzyme, with rifampin (a CYP3A4 inducer) and ketoconazole (a CYP3A4 inhibitor). The researchers conducted two phase I/IIa, two-way crossover studies to evaluate the effects of these interactions on trabectedin's pharmacokinetics, safety, and survival in patients with advanced solid tumors. The results showed that co-administration of rifampin significantly decreased trabectedin's systemic exposure, while co-administration of ketoconazole increased its exposure. This finding has important implications for the safe and effective use of trabectedin in patients receiving concomitant medications that alter CYP3A4 activity.

Navigating the Landscape of Drug Interactions: A Cautionary Tale

This research provides valuable information for clinicians and researchers working with trabectedin. The findings emphasize the importance of careful monitoring for potential toxicities when trabectedin is co-administered with CYP3A4 inhibitors or inducers. The study underscores the need for personalized approaches to cancer treatment, considering the unique metabolic profiles of individual patients.

A Balancing Act: Drug Interactions and Cancer Treatment

Drug interactions can significantly impact the efficacy and safety of cancer treatments. This study serves as a reminder that careful consideration of potential interactions is essential for optimizing patient outcomes. The study highlights the importance of maintaining a careful balance between the benefits of trabectedin and the potential risks associated with drug interactions.

Dr.Camel's Conclusion

This research is like a camel navigating a complex and challenging desert landscape. Understanding the intricate interplay between medications is essential for ensuring safe and effective cancer treatment. This study emphasizes the importance of personalized medicine and the need for cautious co-administration of drugs that interact with CYP3A4.

Date :
  1. Date Completed 2015-02-20
  2. Date Revised 2018-12-11
Further Info :

Pubmed ID

25100135

DOI: Digital Object Identifier

10.1007/s00280-014-2554-1

Related Literature

Article Analysis
・Side Effects of ketoconazole
SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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