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

Primary Purpose

Hepatocellular Carcinoma (HCC)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
brivanib (active)
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma (HCC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • City Of Hope National Medical Center
  • Harbor-Ucla Medical Center
  • Christiana Care Health Services
  • University Of Miami Miller School Of Medicine
  • Northwestern University Feinberg School Of Medicine
  • University Of Chicago
  • University Of Iowa Hospitals And Clinics
  • Wayne State University
  • The Cancer Center At Hackensack University Medical Center
  • Duke University Medical Center
  • Penn State Milton S. Hershey Medical Center
  • Albert Einstein Cancer Center
  • Univ Of Texas Southwestern
  • Md Anderson Cancer Center
  • Medical College Of Wisconsin
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

no comparator to brivanib

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Estimate tumor response rate, time to response, duration of response, overall survival, progression free survival & disease control rate for subjects with no prior systemic therapy & for subjects with 1 prior regimen of angiogenesis inhibitor therapy.
To estimate the safety and tolerability for all BMS582664 (brivanib) treated patients
To obtain population PK, PD

Full Information

First Posted
July 20, 2006
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00355238
Brief Title
A Phase II Open Label Study of BMS-582664 in Locally Advanced or Metastatic Hepatocellular Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma (HCC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
no comparator to brivanib
Intervention Type
Drug
Intervention Name(s)
brivanib (active)
Other Intervention Name(s)
BMS-582664
Intervention Description
Tablet, Oral, Brivanib 800 mg, once daily, until progression
Primary Outcome Measure Information:
Title
To estimate the 6 month progression free locally advanced or metastatic hepatocellular carcinoma (HCC) with no prior chemotherapy for HCC treated with BMS-582664.
Time Frame
throughout the study
Secondary Outcome Measure Information:
Title
Estimate tumor response rate, time to response, duration of response, overall survival, progression free survival & disease control rate for subjects with no prior systemic therapy & for subjects with 1 prior regimen of angiogenesis inhibitor therapy.
Time Frame
throughout the study
Title
To estimate the safety and tolerability for all BMS582664 (brivanib) treated patients
Time Frame
throughout the study
Title
To obtain population PK, PD
Time Frame
throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
City Of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Harbor-Ucla Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
University Of Miami Miller School Of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern University Feinberg School Of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University Of Iowa Hospitals And Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
The Cancer Center At Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Albert Einstein Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Univ Of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Md Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medical College Of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Local Institution
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Local Institution
City
Reims Cedex
ZIP/Postal Code
51092
Country
France
Facility Name
Local Institution
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Local Institution
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Local Institution
City
Shatin, Nt.,
Country
Hong Kong
Facility Name
Local Institution
City
Gyeonggi-Do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Local Institution
City
Nilai
State/Province
Negeri Sembilan
ZIP/Postal Code
71800
Country
Malaysia
Facility Name
Local Institution
City
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Local Institution
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Local Institution
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Local Institution
City
Quezon
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Local Institution
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Local Institution
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Local Institution
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
21349999
Citation
Park JW, Finn RS, Kim JS, Karwal M, Li RK, Ismail F, Thomas M, Harris R, Baudelet C, Walters I, Raoul JL. Phase II, open-label study of brivanib as first-line therapy in patients with advanced hepatocellular carcinoma. Clin Cancer Res. 2011 Apr 1;17(7):1973-83. doi: 10.1158/1078-0432.CCR-10-2011. Epub 2011 Feb 24.
Results Reference
derived

Learn more about this trial

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

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