Clinical Trials Search
Clinical Trial 17904
Cancer Type: Sarcoma
Interventions:BAY 73-4506 (Regorafenib); Placebo; Regorafenib
Study Type: Treatment
Phase of Study: Phase II
SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients with Refractory Liposarcoma, Osteogenic Sarcoma, and Ewing/Ewing-Like Sarcomas
The purpose of this study is to find out if an investigational drug called regorafenib can help people with sarcoma. Regorafenib is approved in the United States to treat colon cancer and one form of sarcoma (GIST), but we do not know if regorafenib is useful to treat people with liposarcoma, osteosarcoma, and Ewing / Ewing-like sarcomas.
Primary Objective: A. Cohort A (liposarcoma): To compare the progression-free survival (PFS) of eligible subjects treated with regorafenib or placebo according to modified RECIST version 1.1. B. Cohort B (osteogenic sarcoma): To compare the progression-free survival (PFS) of eligible subjects treated with regorafenib or placebo according to RECIST version 1.1. C. Cohort C (Ewing/Ewing-like sarcoma): To estimate the RECIST 1.1 PFS rate of eligible subjects treated with regorafenib at 8 and 16 weeks. Secondary Objectives: A. All cohorts: Calculate the incidence of reported CTCAE v 4.0 adverse events and abnormal laboratory test results. B. All cohorts: Estimate the overall response rate (ORR) per RECIST version 1.1, time to tumor progression (TTP), PFS (12 weeks), overall survival (OS), disease specific survival (DSS). C. Cohort A & B, after crossover: Assess PFS, RR, TTP, OS, and DSS following administration of regorafenib in the open label portion of the study. Exploratory Objectives: A. Assess PFS and RR in these populations by Choi criteria. B. Growth modulation index for treatment with regorafenib vs. prior line of therapy, defined as TTPregorafenib/TTPprior.