Phase 1 study of sorafenib and eribulin in patients with advanced, metastatic or refractory solid tumors

© The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissionsoup.com.Background: Combining sorafenib (SOR), an oral multikinase inhibitor approved for hepatocellular carcinoma,...

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Main Author: Marmé, Frederik (Author)
Format: Article (Journal)
Language:English
Published: 1 October 2016
In: Annals of oncology
Year: 2016, Volume: 27, Pages: vi114-vi135
ISSN:1569-8041
DOI:10.1093/annonc/mdw368.40
Online Access:Verlag, kostenfrei, Volltext: http://dx.doi.org/10.1093/annonc/mdw368.40
Verlag, kostenfrei, Volltext: https://academic.oup.com/annonc/article/27/suppl_6/397P/2799135/Phase-1-study-of-sorafenib-and-eribulin-in
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Author Notes:F. Marmé, C. Gomez-Roca, K. Graudenz, F. Huang, J. Lettieri, C. Pena, Z. Trnkova, J. Eucker

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520 |a © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissionsoup.com.Background: Combining sorafenib (SOR), an oral multikinase inhibitor approved for hepatocellular carcinoma, renal cell carcinoma, and differentiated thyroid carcinoma, with eribulin mesylate (ERI), a microtubule inhibitor approved for breast cancer (BC), may provide synergistic antitumor activities.Methods: This phase 1b, open label, dose escalation study evaluated safety, pharmacokinetics (PK), maximum tolerated dose/recommended phase 2 dose (MTD/RP2D), cardiac safety (QT/QTc), and preliminary efficacy of SOR + standard dose ERI (1.4 mg/kg IV on Days [D] 1 and 8 of each 21-day cycle [C]) in patients (pts) with advanced, metastatic, or refractory tumors. Starting SOR dose was 200 mg BID continuously starting on D11 of C1. SOR + ERI-related hematologic and nonhematologic dose limiting toxicities (DLT) were assessed in C2. If tolerable, SOR was escalated in... 
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