A phase 1 study of eribulin mesylate (E7389), a novel microtubule targeting chemotherapeutic agent in children with refractory or recurrent solid tumors (excluding CNS), including lymphomas: a Children's Oncology Group Phase 1 Consortium study (ADVL1314)
| Autor: | Eric S. Schafer, Charles G. Minard, Elizabeth Fox, Rachael Scott, Susan M. Blaney, Rachel E. Rau, Gresel Martinez, Larisa Reyderman, D. R. D'Adamo, Brenda J. Weigel, Xiaowei Liu |
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| Rok vydání: | 2016 |
| Předmět: | |
| Zdroj: | Journal of Clinical Oncology. 34:2567-2567 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2016.34.15_suppl.2567 |
| Popis: | 2567Background: Eribulin mesylate, a synthetic analog of Halichondrin B, is a novel microtubule dynamics inhibitor. It inhibits microtubule growth without effects on microtubule shortening and promotes nonproductive tubulin aggregate formation. We performed a phase 1 trial to determine the dose limiting toxicities (DLT), maximum tolerated dose (MTD) and pharmacokinetics (PK) of eribulin in children with refractory or recurrent solid tumors, including lymphomas. Methods: Eribulin was administered intravenously on days 1 and 8 in 21-day cycles. Three dose levels (1.1, 1.4 and 1.8 mg/m2/dose) were evaluated using the rolling-6 design with additional patients enrolled into a PK expansion cohort at the MTD/recommended phase 2 dose (RP2D). PK samples were obtained following the Day 1 dose of cycle 1. Results: To date, 23 patients ages 3-17 (median 14) years have been enrolled, with 21 fully evaluable for toxicity. Subjects enrolled with 10 unique tumor types the most common of which were osteosarcoma (n = 9) an... |
| Databáze: | OpenAIRE |
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