Duke logo

Eisai H3B-6527-G000-101 for HCC or ICC - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find the maximum dose of the study drug that is safe for patients to take. We also want to learn if the study drug can make the size of your tumor smaller.

What is the Condition Being Studied?

Advanced hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC)

Who Can Participate in the Study?

Adults who:
- Have advanced hepatocellular carcinoma or intrahepatic cholangiocarcinoma
- Have had treatment with sorafenib if you have HCC or have had cisplatin/oxaliplatin if you have ICC

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Take the study drug, called H3B-6527, by mouth every day in 21 day cycles
- Continue to take the study drug as long as the study doctors thinks it is safe

Study Details

Full Title
An Open-Label Multicenter Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Subjects With Advanced Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma
Principal Investigator
Protocol Number
IRB:PRO00085459
NCT:NCT02834780
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698