A phase 1b study with selinexor, a first in class selective inhibitor of nuclear export (SINE) in patients with advanced sarcomas: An efficacy analysis
| Autor: | Robert W. Carlson, Alona Zer, Sharon Shacham, Tami Rashal, Lanier R. Tanner, Ping Chi, Sandra P. D'Angelo, Jean-Richard Saint-Martin, Abha A. Gupta, Mary Louise Keohan, Albiruni Ryan Abdul Razak, Mark A. Dickson, William D. Tap, Dilara McCauley, Mrinal M. Gounder, Mansoor Raza Mirza, Theresa Konen, Gary K. Schwartz, Michael Kauffman, Tracey Marshall |
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| Rok vydání: | 2015 |
| Předmět: | |
| Zdroj: | Journal of Clinical Oncology. 33:10569-10569 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2015.33.15_suppl.10569 |
| Popis: | 10569 Background: Sarcomas are a heterogeneous group of malignancies with diverse genetic abnormalities. Selinexor is a first-in-class, oral, inhibitor of XPO1, (nuclear exportin protein 1) with potent anti-tumor activity in multiple sarcoma cell lines and in murine liposarcoma xenografts. Here we report results from a Phase 1b dose expansion trial of selinexor in sarcoma patients (NCT01896505). Methods: Patients (pts) with advanced, refractory sarcomas with radiographic progression received oral selinexor at 50 mg/m2 twice weekly per 28 day cycle. Pharmacokinetics (PK, n = 12) was assessed in the fasted and fed state. Pharmacodynamic studies were performed on fresh tumor biopsies. Response was evaluated every 2 cycles (RECIST 1.1). Results: 36 pts (14 M / 22 F, ECOG 0/1: 19/17, median age 57.5 years [range 18–86], median lines of previous treatments: 3 [range 1–9]). Disease subtypes include liposarcoma (LPS; N = 12), leiomyosarcoma (LMS; N = 8) and other sarcomas (N = 16). Grade 3 drug related adverse ev... |
| Databáze: | OpenAIRE |
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