Abstract Title:

A Phase I trial of GBS-01 for Advanced Pancreatic Cancer Refractory to Gemcitabine.

Abstract Source:

Cancer Sci. 2016 Sep 29. Epub 2016 Sep 29. PMID: 27685612

Abstract Author(s):

Masafumi Ikeda, Akihiro Sato, Nobuo Mochizuki, Kayo Toyosaki, Chika Miyoshi, Rumi Fujioka, Shuichi Mitsunaga, Izumi Ohno, Yusuke Hashimoto, Hideaki Takahashi, Hiromi Hasegawa, Shogo Nomura, Ryuji Takahashi, Satoshi Yomoda, Katsuya Tsuchihara, Satoshi Kishino, Hiroyasu Esumi

Article Affiliation:

Masafumi Ikeda

Abstract:

GBS-01, an extract from the fruit of Arctium lappa Linné 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 (DLT) and pharmacokinetics in patients with advanced pancreatic cancer refractory to gemcitabine. Patients with advanced pancreatic adenocarcinoma who were refractory to gemcitabine were enrolled. GBS-01 was administered orally at escalating doses from 3.0 g (containing 1.0 g of burdock fruit extract) to 12.0 g qd.DLT was defined as grade 4 hematological toxicities and grade 3 or 4 non-hematological toxicities appearing during first 28 days of treatment. Fifteen patients [GBS-01dose level 1 (3.0 g): 3 patients; dose level 2 (7.5 g): 3 patients; dose level 3 (12.0 g): 9 patients] were enrolled. None of the patients at any of the three dose levels exhibited any signs of DLT. The main adverse events were increased serum γGTP, 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 months 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 qd, and favorable clinical responses were obtained. The trial was registered at UMIN-CTR (UMIN000005787). This article is protected by copyright. All rights reserved.

Study Type : Human Study

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