NCT01540461

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_1 hepatocellular-carcinoma

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 28, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

July 8, 2014

Status Verified

June 1, 2014

Enrollment Period

1.7 years

First QC Date

February 23, 2012

Last Update Submit

July 4, 2014

Conditions

Hepatocellular Carcinoma

Keywords

HCC

Outcome Measures

Primary Outcomes (8)

  • Maximum observed plasma concentration (Cmax) of Brivanib

    Days 1, 2, 8, 9 and 15

  • Trough observed plasma concentration (Cmin) of Brivanib

    Days 1, 2, 8, 9 and 15

  • Time of maximum observed plasma concentration (Tmax) of Brivanib

    Days 1, 2, 8, 9 and 15

  • 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

  • Average steady state concentration calculated as AUC(TAU)/24 (Css_av) of Brivanib

    Days 1, 2, 8, 9 and 15

  • Degree of fluctuation calculated as ((Cmax- Cmin)/Css_av) [Degree of fluctuation] of Brivanib

    Days 1, 2, 8, 9 and 15

  • Terminal half-life (T-HALF) of Brivanib

    Days 1, 2, 8, 9 and 15

  • 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

Secondary Outcomes (2)

  • 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)

  • 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)

Study Arms (1)

Arm: Brivanib

EXPERIMENTAL
Drug: Brivanib

Interventions

BrivanibDRUG

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

Also known as: BMS-582664
Arm: Brivanib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Local Institution

Beijing, Beijing Municipality, 100071, China

Location

Local Institution

Harbin, Heilongjiang, 150040, China

Location

Local Institution

Nanjing, Jiangsu, 210002, China

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

brivanib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2012

First Posted

February 28, 2012

Study Start

March 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

July 8, 2014

Record last verified: 2014-06

Locations

CN(3)