Clinical trial NCT00355238: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma (HCC)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-07-21
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression Free Survival (PFS) Rate at 6 Months Per Independent Response Review Committee (IRRC) in Cohort A
timeFrame: From first dose up to approximately 6 months after first dose
measure: The Number of Participants Experiencing Adverse Events (AEs)
timeFrame: From first dose up to 30 days post last dose (up to approximately 34 months)
Secondary outcomes:
measure: Tumor Response Rate Per Independent Response Review Committee (IRRC)
timeFrame: From first dose to the date of the first documented response (up to approximately 34 months)
measure: Disease Control Rate Per Independent Response Review Committee (IRRC)
timeFrame: From first dose to the date of the first documented response (up to approximately 34 months)
measure: Overall Survival for Participants With No Prior Systemic Therapy
timeFrame: From first dose to the date of death (up to approximately 34 months)
measure: Overall Survival for Participants With One Prior Angiogenesis Inhibitor Therapy
timeFrame: From first dose to the date of death (up to approximately 34 months)
measure: Progression Free Survival (PFS) Per Independent Response Review Committee (IRRC)
timeFrame: From first dose to the date of the first documented progression (up to approximately 34 months)
measure: Time to Response Per Independent Response Review Committee (IRRC)
timeFrame: From first dose to the date of the first documented response (up to approximately 34 months)
measure: Duration of Response Per Independent Response Review Committee (IRRC)
timeFrame: From first dose to the date of documented progressive disease or death (up to approximately 34 months)
measure: Change From Baseline to End of Treatment in FHSI-8 Total Score
timeFrame: Baseline and end of treatment (up to approximately 33 months)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City Of Hope National Medical Center
state: California
city: Duarte
country: United States
facility: City Of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: Harbor UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: Harbor-Ucla Medical Center
state: California
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Miami
country: United States
facility: University Of Miami Miller School Of Medicine
state: Florida
city: Chicago
country: United States
facility: Northwestern University Feinberg School Of Medicine
state: Illinois
city: Chicago
country: United States
facility: University Of Chicago
state: Illinois
city: Iowa City
country: United States
facility: University Of Iowa Hospitals And Clinics
state: Iowa
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Hackensack
country: United States
facility: The Cancer Center At Hackensack University Medical Center
state: New Jersey
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: Univ Of Texas Southwestern
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Md Anderson Cancer Center
state: Texas
city: Milwaukee
country: United States
facility: Medical College Of Wisconsin
state: Wisconsin
city: Marseille
country: France
facility: Local Institution
city: Reims Cedex
country: France
facility: Local Institution
city: Rennes
country: France
facility: Local Institution
city: Villejuif
country: France
facility: Local Institution
city: Shatin, Nt.,
country: Hong Kong
facility: Local Institution
city: Gyeonggi-Do
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Nilai
country: Malaysia
facility: Local Institution
state: Negeri Sembilan
city: Kuala Lumpur
country: Malaysia
facility: Local Institution
city: Cebu City
country: Philippines
facility: Local Institution
city: Davao City
country: Philippines
facility: Local Institution
city: Quezon
country: Philippines
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Tainan
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
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.