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• W2336698538 abstract "275 Background: Resminostat (4SC-201) is a novel oral pan-HDAC inhibitor in clinical development in a variety of cancer indications. The aim of the SHELTER study is to evaluate safety, tolerability, and efficacy in patients (pts) with HCC exhibiting progressive disease under sorafenib first-line therapy. Methods: Sorafenib-refractory pts with advanced HCC, BCLC B or C are included in a multicenter, open-label, two-arm parallel group trial. Resminostat is administered orally on three dose levels of 200 (DL1), 400 (DL2), and 600 mg (DL3) once daily, in combination with 400 mg sorafenib (arm A) or as mono therapy (600 mg, arm B). For arm A, a precedent dose escalation of resminostat and sorafenib is performed to determine the MTD. Resminostat is administered in a “5+9” dosing schedule, consisting of 5 consecutive treatment days (D1-5) followed by a 9-day rest period resulting in 14 day cycles. In arm A sorafenib is given twice daily throughout the treatment period. Primary objective is to determine progression-free survival rate after 12 weeks (6 cycles). Secondary objectives include safety and tolerability, tumor response, estimation of TTP, OS, assessment of PK, and biomarkers. Results: To date, 14 pts were treated either with 600 mg resminostat alone or on DL1-3 in combination with 400 mg sorafenib. The majority of AE observed so far include gastrointestinal disorders such as nausea and vomiting. Plasma exposure to resminostat increased dose-dependently on D1 (cycle 1) with mean AUC 0-6 h values of 10.5 h*mg/L (600 mg mono) and 9.01 h*mg/L (DL3). No major changes in PK characteristics of resminostat were found with or without co-administration of sorafenib. A considerable portion of patients showed stabilization of their disease (SD): 9 out of 12 pts and 4 out of 5 pts examined after 6 and 12 weeks, respectively, displayed SD. In one patient treated on DL2, SD persisted for 36 weeks along with good long-term tolerability. Conclusions: Preliminary clinical data confirmed the favorable oral drug profile of resminostat either in mono or in combination treatment with sorafenib. Initial data on therapeutic activity to overcome resistance to sorafenib are promising. [Table: see text]" @default.
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• W2336698538 date "2011-02-01" @default.
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• W2336698538 title "Clinical update on the SHELTER study: A phase I/II trial of the HDAC inhibitor resminostat in patients with sorafenib-resistant hepatocellular carcinoma (HCC)." @default.
• W2336698538 doi "https://doi.org/10.1200/jco.2011.29.4_suppl.275" @default.
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