Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)

Summary

Phase I-II, non-randomized, single-arm, open-label, multicenter, international clinical trial. Patients with advanced soft-tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) will receive selinexor in combination with gemcitabine.

Timeline

Start

2023-09-28

Primary completion

2026-05-31

Completion

2026-05-31

Publications

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• Background Kashyap T, Argueta C, Unger T, Klebanov B, Debler S, Senapedis W, Crochiere ML, Lee MS, Kauffman M, Shacham S, Landesman Y. Selinexor reduces the expression of DNA damage repair proteins and sensitizes cancer cells to DNA damaging agents. Oncotarget. 2018 Jul 20;9(56):30773-30786. doi: 10.18632/oncotarget.25637. eCollection 2018 Jul 20.
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• Background Gravina GL, Tortoreto M, Mancini A, Addis A, Di Cesare E, Lenzi A, Landesman Y, McCauley D, Kauffman M, Shacham S, Zaffaroni N, Festuccia C. XPO1/CRM1-selective inhibitors of nuclear export (SINE) reduce tumor spreading and improve overall survival in preclinical models of prostate cancer (PCa). J Hematol Oncol. 2014 Oct 5;7:46. doi: 10.1186/1756-8722-7-46.
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• Background Al-Ezzi E, Gounder M, Watson G, Mazzocca A, D'Angelo SP, Bravetti J, Wang H, Abdul Razak A, Vincenzi B. Selinexor, a First in Class, Nuclear Export Inhibitor for the Treatment of Advanced Malignant Peripheral Nerve Sheath Tumor. Oncologist. 2021 Apr;26(4):e710-e714. doi: 10.1002/onco.13692. Epub 2021 Feb 17.
• Background Kolberg M, Bruun J, Murumagi A, Mpindi JP, Bergsland CH, Holand M, Eilertsen IA, Danielsen SA, Kallioniemi O, Lothe RA. Drug sensitivity and resistance testing identifies PLK1 inhibitors and gemcitabine as potent drugs for malignant peripheral nerve sheath tumors. Mol Oncol. 2017 Sep;11(9):1156-1171. doi: 10.1002/1878-0261.12086. Epub 2017 Jul 5.
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• Background Sobczuk P, Teterycz P, Czarnecka AM, Switaj T, Kosela-Paterczyk H, Kozak K, Falkowski S, Rutkowski P. Systemic Treatment for Advanced and Metastatic Malignant Peripheral Nerve Sheath Tumors-A Sarcoma Reference Center Experience. J Clin Med. 2020 Sep 29;9(10):3157. doi: 10.3390/jcm9103157.

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Indications