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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540461
• Other study ID #: CA182-064
• Status: Completed
• Phase: Phase 1
• First received: February 23, 2012
• Last updated: July 4, 2014
• Start date: March 2012
• Est. completion date: November 2013

Study information

• Verified date: June 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: State Administration of Traditional Chinese Medicine of the People's Republic of ChinaChina: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Local Institution	Beijing	Beijing
China	Local Institution	Ha Erbin	Heilongjiang
China	Local Institution	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of Brivanib		Days 1, 2, 8, 9 and 15	No
Primary	Trough observed plasma concentration (Cmin) of Brivanib		Days 1, 2, 8, 9 and 15	No
Primary	Time of maximum observed plasma concentration (Tmax) of Brivanib		Days 1, 2, 8, 9 and 15	No
Primary	Area under the plasma concentration-time curve from time zero to the end of the dosing interval [AUC(TAU)] of Brivanib		Days 1, 2, 8, 9 and 15	No
Primary	Average steady state concentration calculated as AUC(TAU)/24 (Css_av) of Brivanib		Days 1, 2, 8, 9 and 15	No
Primary	Degree of fluctuation calculated as ((Cmax- Cmin)/Css_av) [Degree of fluctuation] of Brivanib		Days 1, 2, 8, 9 and 15	No
Primary	Terminal half-life (T-HALF) of Brivanib		Days 1, 2, 8, 9 and 15	No
Primary	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		Days 1, 2, 8, 9 and 15	No
Secondary	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		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)	Yes
Secondary	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		Screening, Week 7 and every 6 weeks up to End of treatment (approximately 24 months)	No

External Links

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