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A Phase II Open Label Study of Brivanib (BMS582664), Administered Orally At A Dose of 800 mg Daily In Subjects With Unresectable, Locally Advanced or Metastatic Hepatocellular Carcinoma Who Have Received Either No Prior Systemic Therapy or One Prior Regimen of Angiogenesis Inhibitor Therapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Hepatocellular Carcinoma (HCC)

Thank you

Trial Information

A Phase II Open Label Study of Brivanib (BMS582664), Administered Orally At A Dose of 800 mg Daily In Subjects With Unresectable, Locally Advanced or Metastatic Hepatocellular Carcinoma Who Have Received Either No Prior Systemic Therapy or One Prior Regimen of Angiogenesis Inhibitor Therapy


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate the 6 month progression free locally advanced or metastatic hepatocellular carcinoma (HCC) with no prior chemotherapy for HCC treated with BMS-582664.

Outcome Time Frame:

throughout the study

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA182-006

NCT ID:

NCT00355238

Start Date:

December 2006

Completion Date:

April 2010

Related Keywords:

  • Hepatocellular Carcinoma (HCC)
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location
MD Anderson Cancer Center Houston, Texas  77030-4096
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Albert Einstein Cancer Center Philadelphia, Pennsylvania  19141
City of Hope National Medical Center Los Angeles, California  91010
Duke University Medical Center Durham, North Carolina  27710
Wayne State University Detroit, Michigan  48202
University of Chicago Chicago, Illinois  60637
Northwestern University Feinberg School of Medicine Chicago, Illinois  60611
The Cancer Center at Hackensack University Medical Center Hackensack, New Jersey  07601
Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Christiana Care Health Services Newark, Delaware  19713
University Of Miami Miller School Of Medicine Miami, Florida  33010
Harbor-UCLA Medical Center Torrance, California  90509
Univ Of Texas Southwestern Dallas, Texas  75390