SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC)

Completed · Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT01752933

Run by

Astex Pharmaceuticals, Inc.

People needed

52

Starts

2012-12-01

Expected to finish

2015-09-01

Last updated by the study team

2024-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• 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
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Acceptable organ function
• Signed an approved informed consent

You may not qualify if…

• Known hypersensitivity to SGI-110
• 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
• Known brain metastases
• Clinically evident ascites
• Child-Pugh C cirrhosis or Child-Pugh B cirrhosis with more than 7 points
• Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, non-metastatic prostate cancer with normal prostate-specific antigen (PSA) or other cancer from which the subject has been disease free for at least three years
• Known history of human immunodeficiency virus (HIV)

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• UC Davis Comprehensive Cancer Center — Sacramento, California, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Northwestern University: Robert H. Lurie Comprehensive Cancer Center — Chicago, Illinois, United States
• University of Louisville James Graham Brown Cancer Center — Louisville, Kentucky, United States
• Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center — New York, New York, United States
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina, Hollings Cancer Center — Charleston, South Carolina, United States
• The Jones Clinic, PC — Germantown, Tennessee, United States
• Mary Crowley Medical Research Center — Dallas, Texas, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• UW Carbone Cancer Center — Madison, Wisconsin, United States
• University of British Columbia and Vancouver General Hospital — Vancouver, British Columbia, Canada
• The Ottawa Hospital Cancer Center — Ottawa, Ontario, Canada
• Sunnybrook HealthScience Centre — Toronto, Ontario, Canada
• CHUM Hopital St-Luc — Montreal, Quebec, Canada
• Centre Hospitalier Universitaire de Sherbrooke — Sherbrooke, Quebec, Canada
• University of Liverpool Clatterbridge Cancer Center — Liverpool, United Kingdom
• Cambridge University Hospitals NHS Foundation Trust — London, United Kingdom
• Imperial College Healthcare NHS Foundation Trust — London, United Kingdom
• University College London — London, United Kingdom

Full record on ClinicalTrials.gov

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