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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 20, 2006

Last Updated Date

May 3, 2011

Start Date ^ICMJE

December 2006

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00355238 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Hepatocellular Carcinoma (HCC)

Intervention ^ICMJE

Drug: brivanib (active)

Tablet, Oral, Brivanib 800 mg, once daily, until progression

Other Name: BMS-582664

Study Arm (s)

Experimental: 1

no comparator to brivanib

Intervention: Drug: brivanib (active)

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

135

Completion Date

April 2010

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, France, Hong Kong, Korea, Republic of, Malaysia, Philippines, Singapore, Taiwan

Administrative Information

NCT Number ^ICMJE

NCT00355238

Other Study ID Numbers ^ICMJE

CA182-006

Has Data Monitoring Committee

Yes

Responsible Party

Study Director, Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

May 2011

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

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