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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum observed plasma concentration (Cmax) of Brivanib

Outcome Time Frame:

Days 1, 2, 8, 9 and 15

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA182-064

NCT ID:

NCT01540461

Start Date:

April 2012

Completion Date:

August 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • HCC
  • Carcinoma
  • Carcinoma, Hepatocellular

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