A multicenter phase II study of TSU-68, a novel oral multiple tyrosine kinase inhibitor, in patients with metastatic breast cancer progressing despite prior treatment with an anthracycline-containing regimen and taxane.

International Journal of Clinical Oncology
Yasuhiro SuzukiYutaka Tokuda

Abstract

TSU-68 is a novel multiple tyrosine kinase inhibitor that inhibits vascular endothelial growth factor receptor-2, platelet-derived growth factor receptor and fibroblast growth factor receptor. TSU-68 demonstrated a strong anti-tumor effect against established human breast cancer xenografts in nude mice without apparent toxicity. We conducted a phase II study to evaluate the efficacy and safety of TSU-68 monotherapy in patients with metastatic breast cancer progressing despite prior treatment with an anthracycline-containing regimen and taxane. TSU-68 was administered daily at a dose of 400 mg twice a day after meals in 20 patients. The primary endpoint was objective overall response rate according to the Response Evaluation Criteria in Solid Tumors guideline version 1.0. Secondary endpoints included clinical benefit rate (complete response, partial response and stable disease lasting for at least 24 weeks), exploratory assessments of change in mRNA levels of biological markers associated with angiogenesis in tumor tissue at the end of Cycle 1, and safety of TSU-68. Twenty patients were enrolled into the study from October 2002 through April 2003. TSU-68 monotherapy produced objective overall response in none of the patients; ho...Continue Reading

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Citations

Oct 27, 2012·Journal of Medicinal Chemistry·Francesca MusumeciSilvia Schenone
Feb 14, 2015·Breast Cancer Research and Treatment·Fabrice André, Javier Cortés
Sep 24, 2015·Current Opinion in Oncology·Carmen CriscitielloGiuseppe Curigliano
Jul 22, 2015·Cancer Research and Treatment : Official Journal of Korean Cancer Association·Changhoon YooHyun-Cheol Chung

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