Determine the Pharmacokinetics and Safety of Brivanib in Chinese Subjects With Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT01540461

First received: February 23, 2012

Last updated: September 7, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 23, 2012

Last Updated Date

September 7, 2012

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum observed plasma concentration (Cmax) of Brivanib [ Time Frame: Days 1, 2, 8, 9 and 15 ] [ Designated as safety issue: No ]
Trough observed plasma concentration (Cmin) of Brivanib [ Time Frame: Days 1, 2, 8, 9 and 15 ] [ Designated as safety issue: No ]
Time of maximum observed plasma concentration (Tmax) of Brivanib [ Time Frame: Days 1, 2, 8, 9 and 15 ] [ Designated as safety issue: No ]
Area under the plasma concentration-time curve from time zero to the end of the dosing interval [AUC(TAU)] of Brivanib [ Time Frame: Days 1, 2, 8, 9 and 15 ] [ Designated as safety issue: No ]
Average steady state concentration calculated as AUC(TAU)/24 (Css_av) of Brivanib [ Time Frame: Days 1, 2, 8, 9 and 15 ] [ Designated as safety issue: No ]
Degree of fluctuation calculated as ((Cmax- Cmin)/Css_av) [Degree of fluctuation] of Brivanib [ Time Frame: Days 1, 2, 8, 9 and 15 ] [ Designated as safety issue: No ]
Terminal half-life (T-HALF) of Brivanib [ Time Frame: Days 1, 2, 8, 9 and 15 ] [ Designated as safety issue: No ]
Accumulation index calculated as the ratio: AUC(TAU) at steady-state (Day 8) divided by AUC(TAU) after the first dose (Day 1) [AI] of Brivanib [ Time Frame: Days 1, 2, 8, 9 and 15 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01540461 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety assessments based on adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs), 2-D Echocardiograms, physical examinations and clinical laboratory tests [ Time Frame: Part A: Day 1-Week 1, Day 8-Week 2, Day 15-Week 3 and Day 29-Week 5, Part B: End of treatment (approximately 24 months) ] [ Designated as safety issue: Yes ]
Preliminary evidence of anti-tumor activity as measured by objective response rate (ORR) and disease control rate (DCR) in Chinese subjects with advanced HCC treated with Brivanib [ Time Frame: Screening, Week 7 and every 6 weeks up to End of treatment (approximately 24 months) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Determine the Pharmacokinetics and Safety of Brivanib in Chinese Subjects With Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)

Official Title ^ICMJE

A Phase 1 Study to Determine the Safety and Pharmacokinetics of Brivanib in Chinese Subjects With Advanced Hepatocellular Carcinoma (HCC)

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of Brivanib in Chinese subjects with Advanced Hepatocellular Carcinoma (HCC).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Hepatocellular Carcinoma

Intervention ^ICMJE

Drug: Brivanib

Tablets, Oral, 800 mg, Once daily, Until withdrawal of consent, disease progression or until unmanageable toxicity

Other Name: BMS-582664

Study Arm (s)

Experimental: Arm: Brivanib

Intervention: Drug: Brivanib

Publications *

Not Provided

* 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

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2014

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects with:

Confirmed Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)
Not having received prior systemic treatment for advanced HCC
Normal or moderately impaired liver function (Child-Pugh Class A or B (CP total score of ≤ 7))
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

Subjects with:

Brain metastasis or evidence of leptomeningeal disease
History of impaired brain function (encephalopathy) or active heart disease
Unmanageable fluid in the abdomen (ascites)
Bleeding esophageal or gastric varices within 2 months prior to inclusion

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

China

Administrative Information

NCT Number ^ICMJE

NCT01540461

Other Study ID Numbers ^ICMJE

CA182-064

Has Data Monitoring Committee

Responsible Party

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

September 2012

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

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