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Title of Journal: Cancer Chemother Pharmacol

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Abbravation: Cancer Chemotherapy and Pharmacology

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Springer-Verlag

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DOI

10.1007/bf02739939

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1432-0843

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Phase IB study of sorafenib in combination with ge

Authors: B Schultheis G Kummer M Zeth E Brendel C Xia M Kornacker D Strumberg
Publish Date: 2011/07/08
Volume: 69, Issue: 2, Pages: 333-339
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Abstract

Sorafenib BAY 439006 a multikinase inhibitor has been shown to inhibit tumor growth and tumor angiogenesis by targeting Raf kinase vascular endothelial growth factor receptor and plateletderived growth factor receptor This study investigated the safety pharmacokinetics and preliminary efficacy of sorafenib in combination with gemcitabine and cisplatinPatients with advanced solid tumors were treated with 75 mg/m2 cisplatin on day 1 and 1250 mg/m2 gemcitabine on days 1 and 8 of each 21day cycle On day 5 of cycle 1 sorafenib 400 mg twice daily was started and continued throughout the complete treatment cycles without interruptionNineteen patients were valid for safety analysis The most frequent toxicities related to the cytotoxic agents were hematological disorders Sorafenibrelated toxicities were skinrelated gastrointestinal and constitutional symptoms No clinically relevant pharmacokinetic drug–drug interaction between sorafenib cisplatin and gemcitabine was detected AUC072 and C max of total and unbound platinum were only marginally changed by concomitant sorafenib Concomitant sorafenib increased mean AUC and C max of gemcitabine by 12 and 21Sorafenib as continuous oral treatment in combination with gemcitabine and cisplatin demonstrated an acceptable safety profile No clinically relevant pharmacokinetic interaction was detected Preliminary antitumor activity pharmacokinetic and safety data support the recommendation of 400 mg sorafenib twice daily in combination with cisplatin and gemcitabine to be further evaluated in clinical studies

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