drugset / Trial / NCT02389244
A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas
RandomizedParallel-groupDouble-blindTreatment
Summary
INDICATION: Metastatic bone sarcomas: conventional high grade osteosarcoma, Ewing sarcoma of bone, intermediate or high-grade chondrosarcomas and chordomas and either bone or soft tissue metastatic CIC-rearranged sarcomas
Timeline
- Start
- 2014-09
- Primary completion
- 2024-10-25
- Completion
- 2026-03-11
Publications
- Duffaud F, Italiano A, Bompas E, Rios M, Penel N, Mir O, Piperno-Neumann S, Chevreau C, Delcambre C, Bertucci F, Boudou-Rouquette P, Cancel M, Perrin C, Saada-Bouzid E, Monard L, Schiffler C, Chaigneau L, Hervieu A, Collard O, Bouvier C, Vidal V, Chabaud S, Blay JY; French Sarcoma Group. Efficacy and safety of regorafenib in patients with metastatic or locally advanced chondrosarcoma: Results of a non-comparative, randomised, double-blind, placebo controlled, multicentre phase II study. Eur J Cancer. 2021 Jun;150:108-118. doi: 10.1016/j.ejca.2021.03.039. Epub 2021 Apr 22.
- Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.
- Duffaud F, Mir O, Boudou-Rouquette P, Piperno-Neumann S, Penel N, Bompas E, Delcambre C, Kalbacher E, Italiano A, Collard O, Chevreau C, Saada E, Isambert N, Delaye J, Schiffler C, Bouvier C, Vidal V, Chabaud S, Blay JY; French Sarcoma Group. Efficacy and safety of regorafenib in adult patients with metastatic osteosarcoma: a non-comparative, randomised, double-blind, placebo-controlled, phase 2 study. Lancet Oncol. 2019 Jan;20(1):120-133. doi: 10.1016/S1470-2045(18)30742-3. Epub 2018 Nov 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Regorafenib | Small molecule | 82 mg/m2 | Oral |
| Subject | Regorafenib | Small molecule | 160 mg | Oral |