A Phase II Open Label Study of BMS-582664 in Locally Advanced or Metastatic Hepatocellular Cancer

Completed · Phase 2

Conditions studied: Hepatocellular Carcinoma (HCC)

In brief

The purpose of this clinical research study is to learn if BMS-582664 can shrink or slow the growth of advanced liver cancer. The safety of this treatment will also be studied.

Key facts

Study ID

NCT00355238

Run by

Bristol-Myers Squibb

People needed

137

Starts

2006-12-31

Expected to finish

2010-04-30

Last updated by the study team

2023-12-01

Who can join

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

You may qualify if…

• Diagnosis of hepatocellular carcinoma (HCC) ≥ 2cm based on:
• Biopsy OR
• Radiological evidence of HCC by contrast-enhanced CT scan or contrast-enhanced AND
• Blood test positive for Hepatitis B or C AND
• Alpha fetoprotein above > 400 mg/L
• Not appropriate for curative surgery
• Screening Blood Pressure <150/100 mmHg, Left Ventricular Ejection Fraction (LVEF) >50%

You may not qualify if…

• Heart Attack within 12 months, uncontrolled chest pain within 6 months
• Ascites resistant to diuretic medication therapy
• Portal-systemic encephalopathy
• Portal hypertension with bleeding esophageal or gastric varices within the past 2 months
• Deficiency of sodium in the blood with sodium < 125 mEq/L
• Subjects with serious non-healing wounds, ulcers or bone fractures

Where it is running

• City Of Hope National Medical Center — Duarte, California, United States
• City Of Hope National Medical Center — Duarte, California, United States
• Harbor UCLA Medical Center — Los Angeles, California, United States
• Harbor-Ucla Medical Center — Los Angeles, California, United States
• Christiana Care Health Services — Newark, Delaware, United States
• University Of Miami Miller School Of Medicine — Miami, Florida, United States
• Northwestern University Feinberg School Of Medicine — Chicago, Illinois, United States
• University Of Chicago — Chicago, Illinois, United States
• University Of Iowa Hospitals And Clinics — Iowa City, Iowa, United States
• Wayne State University — Detroit, Michigan, United States
• Saint Louis University — St Louis, Missouri, United States
• The Cancer Center At Hackensack University Medical Center — Hackensack, New Jersey, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Albert Einstein Cancer Center — Philadelphia, Pennsylvania, United States
• Univ Of Texas Southwestern — Dallas, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Md Anderson Cancer Center — Houston, Texas, United States
• Medical College Of Wisconsin — Milwaukee, Wisconsin, United States
• Local Institution — Marseille, France
• Local Institution — Reims, France
• Local Institution — Rennes, France
• Local Institution — Villejuif, France
• Local Institution — Shatin, Nt.,, Hong Kong
• Local Institution — Kampung Baharu Nilai, Negeri Sembilan, Malaysia

Full record on ClinicalTrials.gov

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