SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin in Combination With Irinotecan in Ewing Sarcoma Patients

Summary

This study evaluates the trabectedin and irinotecan in the treatment of Ewings sarcoma, with a EWS-FLI1 mutation. Patients will also receive an infusion of 18F-FLT in combination with a Positron Emission Tomography (PET) scan to help evaluate the effect of treatment.

Timeline

Start

2021-01-05

Primary completion

2025-04-24

Completion

2025-04-24

Publications

• Grohar PJ, Heise R, Wedekind MF, Ballman K, Mascarenhas L, DuBois SG, Maki RG, Boguslawski EA, Gedminas JM, Wilson ER, Thomas E, Segers B, Surrey LF, Ricker C, Klega K, Navid F, Lam GY, The S, Kaufman R, Roberts RD, Hayashi M, Mena E, Overman L, Peer C, Schmidt K, Diamond MS, Figg WD, Bagatell R, Liza Lindenberg M, Choyke PL, Crompton BD, Widemann BC, Glod JW, Laetsch TW, Reinke DK, Chugh R. Trabectedin and low-dose irinotecan to target EWS::FLI1 in Ewing sarcoma: a phase 1/2 trial. Nat Med. 2026 Jun;32(6):2227-2237. doi: 10.1038/s41591-026-04340-7. Epub 2026 Apr 16.

Drugs

Indications