A Phase 2 Study of SGI-110 in HCC patients (SGI110-03)
Research type
Research Study
Full title
A Phase 2 Study of SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC) Subjects Who Failed Prior Treatment with Sorafenib
IRAS ID
122387
Contact name
Tim Meyer
Contact email
Sponsor organisation
Astex Pharmaceuticals Inc
Eudract number
2012-003977-24
Clinicaltrials.gov Identifier
Research summary
Hepatocellular carcinoma (HCC), is the most common form of primary liver cancer, it can be caused by many different conditions including viral hepatitis, excessive alcohol consumption, hemochromatosis (iron overload), obesity and metabolic syndrome leading to steatosis (fatty change).
Current treatments advanced HCC are limited. A medication called sorafenib is the only available treatment approved by the Food and Drugs Authority (FDA). Sorafenib belongs to a group of drugs called multikinase oral inhibitors that works by electively blocking molecules belonging to two classes of kinases which are involved in the cellular proliferation (division) of tumour angiogenesis (process through which new blood vessels form from pre-existing vessels).
Although Sorafenib resulted in a significant improvement in overall survival in patients treated during clinical trials, there is still an unmet need for treatment of patients who fail to respond to treatment with Sorafenib.
SGI-110 is a drug that breaks down in the body into a compound called decitabine. Decitabine is an approved drug for the treatment of a disease of blood cells called myelodysplastic syndromes (MDS). Decitabine (and therefore the study drug) blocks abnormal cells or cancer cells from growing. The study drug may have other effects that differ from decitabine.
Astex Pharmaceuticals, Inc. is sponsoring this study to evaluate the safety, tolerability and effectiveness of SGI-110 and any potential benefits in participants with HCC who progressed after treatment with sorafenib.
This is an open-label study, which means that participants and the study doctor will know what treatment have been given, as well as the dose and frequency that they are receiving it in.
It is expected that up to 46 participants will partake in the study.REC name
London - Dulwich Research Ethics Committee
REC reference
14/LO/0157
Date of REC Opinion
20 Mar 2014
REC opinion
Further Information Favourable Opinion