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Clinical Trial NU SARC14S01

Title
A Blanket Protocol to Study Oral Regorafenib in Patients with Refractory Liposarcoma, Osteogenic Sarcoma, and Ewing/Ewing–Like Sarcomas
Principal Investigator
Mark Agulnik
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.NU SARC14S01
Purpose
The purpose of this study is to compare the safety (side effects) and effectiveness of giving participants the study drug regorafenib versus a placebo (sugar pill).
Overview
Regorafenib is approved in the United States to treat colon cancer and one form of sarcoma (GI Stromal Tumor, or GIST). We do not know, however, if regorafenib is a useful treatment for people with other types of sarcoma. Thus, the drug regorafenib is considered “investigational” in this study. The term “investigational” means that the drug used in this study has not been approved by the Food and Drug Administration (FDA). A drug similar to the one being tested in this study, called pazopanib, is approved to treat some sarcomas, but is not approved to treat the type of sarcoma included this this study. Because it is unknown if any of these types of drugs will help people with liposarcoma, osteosarcoma, or Ewing/Ewing-like sarcoma, the goal of this study is to find out if the study drug regorafenib is an effective treatment for people with sarcoma.
Eligibility
Some of the eligibility criteria include:
  • Participants must have either liposarcoma, osteosarcoma or Ewing/Ewing-like sarcoma.
  • The participant's sarcoma must be refractory, meaning it has stopped responding to other treatment.
  • Participants must be 18 or older.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
Participants in this study will be assigned to one of three different groups (cohorts) based on the type of sarcoma they have. Participants who have liposarcoma will be in Cohort A. Those who have osteosarcoma will be in Cohort B. Those in Cohorts A and B will be randomly assigned to get regorafenib or placebo. The study drug and placebo are tablets taken every day. Participants may continue to take the regorafenib/placabo as long as they do not have serious side effects and as long as their sarcoma is not measurably worse. If the tumor does get worse, and the participant was taking the placebo, they will be able to switch to the regorafenib. Participants who have Ewing or Ewing-like sarcoma will be assigned to Cohort C. These participants will all get the study drug regorafenib. These participants will be able to continue on the study drug as long as they do not have serious side effects and as long as their sarcoma is not measurably worse.
Contact
Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 27-Nov-14 11:04 AM

 

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