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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Drug: brivanib (active)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00355238

CA182-006

Details and patient eligibility

About

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.

Enrollment: 137 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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137 participants in 1 patient group

1

Experimental group

Description:

no comparator to brivanib

Treatment:

Drug: brivanib (active)