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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Angiogenesis Inhibitors

Criteria

Inclusion Criteria:

• 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%

Exclusion Criteria:

• 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