Phase I trial of GBS ‐01 for advanced pancreatic cancer refractory to gemcitabine
Rattachement africain : jp. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
GBS-01, an extract from the fruit of Arctium lappa L. is an orally administered drug rich in arctigenin, which has been reported to exert antitumor activity by attenuating the tolerance of cancer cells to glucose deprivation. We investigated the maximum tolerated dose of GBS-01 based on the frequency of the dose-limiting toxicities (DLTs) and pharmacokinetics in patients with advanced pancreatic cancer refractory to gemcitabine. GBS-01 was given orally at escalating doses from 3.0 g (containing 1.0 g burdock fruit extract) to 12.0 g q.d. A DLT was defined as a grade 4 hematological toxicity and grade 3 or 4 non-hematological toxicity appearing during the first 28 days of treatment. Fifteen patients (GBS-01 dose level 1 [3.0 g], three patients; dose level 2 [7.5 g], three patients; and dose level 3 [12.0 g], nine patients) were enrolled. None of the patients at any of the three dose levels showed any sign of DLTs. The main adverse events were increased serum γ-glutamyl transpeptidase, hyperglycemia, and increased serum total bilirubin; however, all the toxicities were mild. Of the 15 patients, 1 showed confirmed partial response and 4 patients had stable disease. The median progression-free and overall survival of the patients were 1.1 and 5.7 months, respectively. The pharmacokinetic study revealed a high bioavailability of arctigenin and rapid conjugation of the drug with glucuronic acid. The recommended dose of GBS-01 was 12.0 g q.d, and favorable clinical responses were obtained. This trial was registered at UMIN-CTR (http://www.umin.ac.jp/ctr/index-j.htm), identification number UMIN000005787.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé, mais le titre doit être comparé manuellement.
- Titre Crossref
- Phase I trial of <scp>GBS</scp>‐01 for advanced pancreatic cancer refractory to gemcitabine
- Date Crossref
- 01/12/2016
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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National Cancer Center Hospital East Department of Hepatobiliary and Pancreatic Oncology pays non établi dans la noticeÉtablissement de santé
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Meiji Pharmaceutical University Department of Medication Use Analysis and Clinical Research pays non établi dans la noticeUniversité ou école supérieure
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Kracie (Japan) pays non établi dans la noticeEntreprise
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Tokyo University of Science Research Institute for Biomedical Sciences pays non établi dans la noticeUniversité ou école supérieure
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Clinical Trial Section pays non établi dans la noticeÉtablissement de santé
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Division of Translational Research Exploratory Oncology and Clinical Trial Center National Cancer Center Kashiwa Japan Division of Translational Research pays non établi dans la noticeÉtablissement de santé
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Biostatistics Division Center for Research Administration and Support National Cancer Center Kashiwa Japan pays non établi dans la noticeInstitution
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Kampo Research Laboratory Kracie Pharma pays non établi dans la noticeStructure de recherche
Department of Hepatobiliary and Pancreatic Oncology — National Cancer Center Hospital East, Department of Medication Use Analysis and Clinical Research — Meiji Pharmaceutical University et Kracie (Japan), avec 5 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.