Last updated on August 2018

A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas


Brief description of study

INDICATION

Metastatic bone sarcomas: conventional high grade osteosarcoma, Ewing sarcoma of bone, intermediate or high-grade chondrosarcomas and chordomas

Detailed Study Description

METHODOLOGY

Randomized, placebo-controlled, multicentric, phase II study -This is a double-blind placebo-controlled trial, with 4 cohort: cohort A: Osteosarcoma cohort B: Ewing sarcoma cohort C: Chondrosarcoma cohort D : chondroma. Cohort A, B and C will involve a total of 36 patients (24 Regorafenib + 12 placebo). And cohort D a total of 24 evaluable patients (16 Regorafenib + 8 placebo) 132 patients who meet the eligibility criteria will be randomly assigned in a 2:1 ratio to the following treatment groups :

The Arm A:

Regorafenib (160 mg/d) once daily for the 3 weeks on / 1 week off plus Best Supportive Care (BSC) until progression (according to RECIST 1.1), intolerance or withdrawal of consent .

Patients receiving regorafenib who experience disease progression and for whom in the investigator opinion, treatment with regorafenib is providing clinical benefit, may continue the treatment following consultation with the study coordinator and the sponsor.

The Arm B:

Placebo plus BSC until progression (according to RECIST V1.1) intolerance or withdrawal of consent. Patients who have received placebo will receive open-label regorafenib after objective tumor progression.

Patients will be stratified at randomization according to histology .

Clinical Study Identifier: NCT02389244

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