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



Status:Completed
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2006
End Date:April 2010

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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

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.


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
We found this trial at
16
sites
Houston, Texas 77030
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Chicago, IL
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Dallas, Texas 75390
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Hackensack, NJ
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Hershey, PA
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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Los Angeles, California 90095
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Marseille, 13273
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Marseille,
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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Newark, Delaware 19713
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Philadelphia, Pennsylvania 19141
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Philadelphia, PA
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