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Clinical Trials: BAY 73-4506/15982: A randomized, double blind, placebo-controlled, multicenter phase III study of regorafenib in patients with hepatocellular carcinoma (HCC) after sorafenib

 


BAY 73-4506/15982: A randomized, double blind, placebo-controlled, multicenter phase III study of regorafenib in patients with hepatocellular carcinoma (HCC) after sorafenib


Trial Focus

Digestive System Cancer

Objective

         This is a clinical trial of investigational drug Regorafenib which will be administered orally.

IRB Protocol #

13-2135

Trial Status

OPEN

Principle Investigator

WILLIAM TOM PURCELL

Sponsor

Bayer Corporation

Contact

DAVID SHENEMAN at -- or DAVID.SHENEMAN@UCDENVER.EDU

Location

University of Colorado Hospital University of Colorado Hospital

Eligibility and Other Participant Information


What To Expect : A screening period will determine eligibility. The length of time you will be in the study depends on your response to the study drug. Each cycle is 28 days long. You will take the study drug for 3 weeks but not during week 4. Every month after you finish the study drug, we will contact you to see how you are doing and to see if you have started any new treatments. This study will involve collection of medical and disease history, ECG, blood draws, CT and MRI of the chest, abdomen and pelvis to determine the location and size of your cancer. The study doctor will request participant's permission to obtain medical information, including CT and/or MRI scans, and liver tissue samples, if available, from other doctors and hospitals previously treated. // Eligibility criteria include but are not limited to 18 years or older with hepatocellular carcinoma (HCC) after sorafenib. Participants must have adequate bone marrow, liver and renal function.Eligibility criteria include but are not limited to 18 years or older with hepatocellular carcinoma (HCC) after sorafenib. Participants must have adequate bone marrow, liver and renal function.