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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00355238
First received: July 20, 2006
Last updated: May 3, 2011
Last verified: May 2011

July 20, 2006
May 3, 2011
December 2006
April 2010   (final data collection date for primary 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. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
To estimate the progression free survival rate in patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) with no prior chemotherapy for HCC treated with either of BMS-582664 or doxorubicin.
Complete list of historical versions of study NCT00355238 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • To estimate the safety and tolerability for all BMS582664 (brivanib) treated patients [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • To obtain population PK, PD [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To estimate he progression free survival rate in patients treated with BMS582664 QD relative to doxorubicin Q3 weeks
  • To estimate tumor response , time to response, duration of response, and survival
  • To estimate the safety and tolerability of BMS582664 and doxorubicin
  • To obtain population PK, PD
Not Provided
Not Provided
 
A Phase II Open Label Study of BMS-582664 in Locally Advanced or Metastatic Hepatocellular Cancer
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma (HCC)
Drug: brivanib (active)
Tablet, Oral, Brivanib 800 mg, once daily, until progression
Other Name: BMS-582664
Experimental: 1
no comparator to brivanib
Intervention: Drug: brivanib (active)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Singapore,   Taiwan,   Korea, Republic of,   Philippines,   Malaysia,   France,   Hong Kong
 
NCT00355238
CA182-006
Yes
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP