Ph II Nintedanib vs. Ifosfamide in Soft Tissue Sarcoma

Summary

This is a prospective, multicentric, randomized, open label Phase II trial investigating whether the oral angiogenesis inhibitor nintedanib, as compared to the intravenous cytotoxic compound ifosfamide, given for patients with advanced, inoperable and/or metastatic STS after failure of first line chemotherapy prolongs progression-free survival. The primary objective of the trial is to evaluate whether nintedanib given as second-line therapy for advanced, inoperable and/or metastatic STS prolongs progression-free survival when compared with ifosfamide. Secondary objectives are to evaluate the efficacy of nintedanib as compared to ifosfamide in terms of progression-free survival rate at 12 weeks, overall survival, objective response rate, patient benefit rate, response duration, total duration of treatment with nintedanib safety, Health related Quality of Life and Health Economics. Exploratory objectives include an analysis of putative predictive biomarkers for the anti-tumor effects of the investigational agent nintedanib.treatment.

Timeline

Start

2017-07-07

Primary completion

2020-11-03

Completion

2021-04-14

Publications

• Schoffski P, Toulmonde M, Estival A, Marquina G, Dudzisz-Sledz M, Brahmi M, Steeghs N, Karavasilis V, de Haan J, Wozniak A, Cousin S, Domenech M, Bovee JVMG, Charon-Barra C, Marreaud S, Litiere S, De Meulemeester L, Olungu C, Gelderblom H. Randomised phase 2 study comparing the efficacy and safety of the oral tyrosine kinase inhibitor nintedanib with single agent ifosfamide in patients with advanced, inoperable, metastatic soft tissue sarcoma after failure of first-line chemotherapy: EORTC-1506-STBSG "ANITA". Eur J Cancer. 2021 Jul;152:26-40. doi: 10.1016/j.ejca.2021.04.015. Epub 2021 May 29.

Drugs

Indications