5349W-12: Gold Astex HCC

CRC 12140: SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC) Subjects Who Failed Prior Treatment With Sorafenib

Type of Study
Cancer (Oncology) - Liver
Swedish Cancer Institute
Short Description

Purpose: A Phase 2 open-label, single-arm, non-randomized study in the treatment of advanced hepatocellular carcinoma (HCC) patients who failed prior treatment with sorafenib using a Simon's 2-stage design. A set minimum number of patients must demonstrate disease control at 16 weeks to proceed to Stage 2. At Stage 2, a set number of patients must have disease control at 16 weeks to declare that SGI-110 is of interest in the treatment of advanced HCC after failure of prior sorafenib.

Open to Enrollment
Principal Investigator
Philip Gold, M.D.
Eligibility Notes

• Histological or cytological confirmed hepatocellular carcinoma with advanced stage disease
• Received prior sorafenib treatment, and showed evidence of disease progression, which is defined as Investigator verified radiologic progression, or intolerance of prior systemic therapy, which is defined as having had clinically significant adverse events that persisted despite one or more dose reductions or interruptions
• ECOG performance status of 0-1
• Adequate washout of prior radiation, chemotherapy or other locoregional therapy
• Abnormal left ventricular ejection fraction
• Uncontrolled ischemic heart disease or a history of congestive cardiac failure
• Clinically evident ascites
• Child-Pugh C cirrhosis or Child-Pugh B cirrhosis with more than 7 points

More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
(206) 215-3086