Randomized Double-Blind Phase II Study of Regorafenib in Patients With Metastatic Osteosarcoma.

ABSTRACT:

Purpose

SARC024 is a phase II clinical trial of the multikinase inhibitor regorafenib in specific sarcoma subtypes, including advanced osteosarcoma. We hypothesized that regorafenib would improve progression-free survival (PFS) in patients with sarcoma and report the results of the osteosarcoma cohort.

Patients and methods

This trial enrolled patients with progressive metastatic osteosarcoma with measurable disease by RECIST who had received at least one prior line of therapy. Patients were randomly assigned at a ratio of one to one to regorafenib or placebo. Crossover was allowed at time of disease progression. PFS was the primary end point of the study, which was powered to detect a difference of at least 3 months in median PFS.

Results

Forty-two patients from 12 ce

SUBMITTER: Davis LE 

PROVIDER: S-EPMC7799443 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature