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

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00355238

Purpose

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.

Condition	Intervention	Phase
Hepatocellular Carcinoma (HCC)	Drug: brivanib (active)	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: BMS540215 Brivanib alaninate

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

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. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

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. [ 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 ]

Enrollment:	135
Study Start Date:	December 2006
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 no comparator to brivanib	Drug: brivanib (active) Tablet, Oral, Brivanib 800 mg, once daily, until progression Other Name: BMS-582664

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355238

Show 33 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Feb 24.

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00355238 History of Changes
Other Study ID Numbers:	CA182-006
Study First Received:	July 20, 2006
Last Updated:	May 3, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases

Liver Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012