Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma (REGO-SARC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01900743

Recruitment Status : Completed

First Posted : July 16, 2013

Last Update Posted : April 9, 2021

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

Bayer

Information provided by (Responsible Party):

Centre Oscar Lambret

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Completed
Actual Primary Completion Date :	September 16, 2020
Actual Study Completion Date :	September 16, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Penel N, Mir O, Wallet J, Ray-Coquard I, Le Cesne A, Italiano A, Salas S, Delcambre C, Bompas E, Bertucci F, Saada-Bouzid E, Chaigneau L, Chevreau C, Brodowicz T, Decoupigny E, Vanseymortier M, Laroche L, Taieb S, Le Deley MC, Blay JY. A double-blind placebo-controlled randomized phase II trial assessing the activity and safety of regorafenib in non-adipocytic sarcoma patients previously treated with both chemotherapy and pazopanib. Eur J Cancer. 2020 Feb;126:45-55. doi: 10.1016/j.ejca.2019.12.001. Epub 2020 Jan 6.

Longue M, Cabarrou B, Wallet J, Brodowicz T, Roche H, Boher JM, Delord JP, Penel N, Filleron T. The importance of jointly analyzing treatment administration and toxicity associated with targeted therapies: a case study of regorafenib in soft tissue sarcoma patients. Ann Oncol. 2018 Jul 1;29(7):1588-1593. doi: 10.1093/annonc/mdy168.

Berry V, Basson L, Bogart E, Mir O, Blay JY, Italiano A, Bertucci F, Chevreau C, Clisant-Delaine S, Liegl-Antzager B, Tresch-Bruneel E, Wallet J, Taieb S, Decoupigny E, Le Cesne A, Brodowicz T, Penel N. REGOSARC: Regorafenib versus placebo in doxorubicin-refractory soft-tissue sarcoma-A quality-adjusted time without symptoms of progression or toxicity analysis. Cancer. 2017 Jun 15;123(12):2294-2302. doi: 10.1002/cncr.30661. Epub 2017 Mar 10.

Mir O, Brodowicz T, Italiano A, Wallet J, Blay JY, Bertucci F, Chevreau C, Piperno-Neumann S, Bompas E, Salas S, Perrin C, Delcambre C, Liegl-Atzwanger B, Toulmonde M, Dumont S, Ray-Coquard I, Clisant S, Taieb S, Guillemet C, Rios M, Collard O, Bozec L, Cupissol D, Saada-Bouzid E, Lemaignan C, Eisterer W, Isambert N, Chaigneau L, Cesne AL, Penel N. Safety and efficacy of regorafenib in patients with advanced soft tissue sarcoma (REGOSARC): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2016 Dec;17(12):1732-1742. doi: 10.1016/S1470-2045(16)30507-1. Epub 2016 Oct 14.

Brodowicz T, Liegl-Atzwager B, Tresch E, Taieb S, Kramar A, Gruenwald V, Vanseymortier M, Clisant S, Blay JY, Le Cesne A, Penel N. Study protocol of REGOSARC trial: activity and safety of regorafenib in advanced soft tissue sarcoma: a multinational, randomized, placebo-controlled, phase II trial. BMC Cancer. 2015 Mar 14;15:127. doi: 10.1186/s12885-015-1143-y.

To Top