Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors

Summary

Prospective, open-label, dose-ranging, uncontrolled phase I/II study of Lurbinectedin in combination with irinotecan. The study will be divided into two stages: a Phase I dose escalation stage and a Phase II expansion stage.

Timeline

Start

2016-05-06

Primary completion

2025-07-01

Completion

2025-07-01

Publications

• Falcon A, Cote GM, Molina-Cerrillo J, Le Cesne A, Rocha P, Bockorny B, Paez D, Martin-Broto J, Chawla SP, Martinez S, Kahatt C, Alfaro V, Siguero M, Jimenez J, Custodio A, Alonso-Orduna V, Lopez C, Kollar A, Soto-Castillo JJ, Paz-Ares L. Pooled safety analysis of lurbinectedin plus irinotecan in patients with advanced solid tumors. Invest New Drugs. 2026 May 4. doi: 10.1007/s10637-026-01616-0. Online ahead of print.
• Ponce S, Ruiz-Torres M, Falcon A, Cote GM, Bernabe R, Lin JJ, Coya JM, Jimenez-Munoz M, Fernandez-Puyuelo P, Sanchez A, Zugazagoitia J, Ucero A, Baena J, Bote de Cabo H, Herrera M, Torres-Jimenez J, Zurera M, Kahatt C, Lopez-Vilarino JA, Martinez S, Siguero M, Malumbres M, Ferrer I, Paz-Ares L. Combination of Lurbinectedin Plus Irinotecan: Preclinical and Early Clinical Results in Patients With Relapsed SCLC. J Thorac Oncol. 2026 Jul;21(7):103654. doi: 10.1016/j.jtho.2026.103654. Epub 2026 Mar 4.
• Falcon A, Ponce S, Cote GM, Gil A, Lin JJ, Bockorny B, Martinez J, Kahatt C, Martinez S, Zubiaur P, Siguero M, Cullell-Young M, Jimenez J, Zugazagoitia J, Paz-Ares L. Phase I results on the efficacy, safety and pharmacokinetics of lurbinectedin and irinotecan in advanced solid tumors. Invest New Drugs. 2025 Aug;43(4):955-967. doi: 10.1007/s10637-025-01583-y. Epub 2025 Sep 18.

Drugs

Indications