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Updated: Feb 14, 2026

An In Vitro System to Study Tumor Dormancy and the Switch to Metastatic Growth
Published on: August 11, 2011
Phase 1, open-label, dose-escalation study of sorafenib in combination with eribulin in patients with advanced,
Frederik Marmé1, Carlos Gomez-Roca2, Kristina Graudenz3
1National Center for Tumor Diseases, Gynecologic Oncology, Heidelberg, Germany.
Abstract:
Combining sorafenib and eribulin mesylate may provide synergistic antitumor activities with limited overlapping toxicities. This phase 1b, open-label, dose-escalation study evaluated safety, pharmacokinetics, maximum tolerated dose/recommended phase 2 dose (MTD/RP2D), and preliminary efficacy of sorafenib plus standard-dose eribulin mesylate in patients with advanced, metastatic, or refractory tumors. Patients received sorafenib 200 mg twice daily (BID; n = 5), 600 mg/day (n = 8), and 400 mg BID (MTD; n = 27). Dose-limiting toxicities were increased alanine aminotransferase and acute coronary syndrome (both grade 3) in the 400-mg BID dose-escalation and expansion cohorts, respectively. No significant increase in mean QTcF duration was observed with eribulin plus sorafenib versus eribulin alone; there were no drug-drug interactions. Five patients achieved partial response; 16 achieved stable disease. The combination of sorafenib and eribulin mesylate presented no unexpected safety concerns and no significant impact on QT/QTc intervals or drug-drug interactions. Sorafenib 400 mg BID plus standard-dose eribulin is the RP2D.
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