Trial of Pazopanib in Patients With Solitary Fibrous Tumor and Extraskeletal Myxoid Chondrosarcoma

Summary

Phase II, open-label, non-randomized, international multicenter clinical trial with two strata (SFT and EMC). 8 sites in Spain, 5 sites in Italy and 5 sites in France. Patients will receive oral pazopanib at 800 mg once daily continuously. Patients will continue to receive treatment until there is evidence of progressive disease, unacceptable toxicity, non-compliance, withdrawn consent or investigator decision. The main goal is to determine the objective response rate (ORR) (confirmed complete response \[CR\] and partial response \[PR\]) in patients with unresectable, locally advanced or metastatic solitary fibrous tumor and extraskeletal myxoid chondrosarcoma, using Choi and RECIST 1.1 criteria respectively.

Timeline

Start

2014-06

Primary completion

2019-12

Completion

2023-03-24

Publications

• Napolitano A, Moura DS, Hindi N, Mondaza-Hernandez JL, Merino-Garcia JA, Ramos R, Dagrada GP, Stacchiotti S, Graziano F, Vincenzi B, Martin-Broto J. Expression of p53 as a biomarker of pazopanib efficacy in solitary fibrous tumours: translational analysis of a phase II trial. Ther Adv Med Oncol. 2022 Aug 6;14:17588359221116155. doi: 10.1177/17588359221116155. eCollection 2022.
• Martin-Broto J, Cruz J, Penel N, Le Cesne A, Hindi N, Luna P, Moura DS, Bernabeu D, de Alava E, Lopez-Guerrero JA, Dopazo J, Pena-Chilet M, Gutierrez A, Collini P, Karanian M, Redondo A, Lopez-Pousa A, Grignani G, Diaz-Martin J, Marcilla D, Fernandez-Serra A, Gonzalez-Aguilera C, Casali PG, Blay JY, Stacchiotti S. Pazopanib for treatment of typical solitary fibrous tumours: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2020 Mar;21(3):456-466. doi: 10.1016/S1470-2045(19)30826-5. Epub 2020 Feb 14.
• Stacchiotti S, Ferrari S, Redondo A, Hindi N, Palmerini E, Vaz Salgado MA, Frezza AM, Casali PG, Gutierrez A, Lopez-Pousa A, Grignani G, Italiano A, LeCesne A, Dumont S, Blay JY, Penel N, Bernabeu D, de Alava E, Karanian M, Morosi C, Brich S, Dagrada GP, Vallacchi V, Castelli C, Brenca M, Racanelli D, Maestro R, Collini P, Cruz J, Martin-Broto J. Pazopanib for treatment of advanced extraskeletal myxoid chondrosarcoma: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2019 Sep;20(9):1252-1262. doi: 10.1016/S1470-2045(19)30319-5. Epub 2019 Jul 19.
• Martin-Broto J, Stacchiotti S, Lopez-Pousa A, Redondo A, Bernabeu D, de Alava E, Casali PG, Italiano A, Gutierrez A, Moura DS, Pena-Chilet M, Diaz-Martin J, Biscuola M, Taron M, Collini P, Ranchere-Vince D, Garcia Del Muro X, Grignani G, Dumont S, Martinez-Trufero J, Palmerini E, Hindi N, Sebio A, Dopazo J, Dei Tos AP, LeCesne A, Blay JY, Cruz J. Pazopanib for treatment of advanced malignant and dedifferentiated solitary fibrous tumour: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2019 Jan;20(1):134-144. doi: 10.1016/S1470-2045(18)30676-4. Epub 2018 Dec 18.

Drugs

Indications