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Completed

NCT Number: NCT00858871

First Line Hepato Cellular Carcinoma (HCC)

The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.

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Key information

Conditions

Hepato Cellular Carcinoma (HCC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Inclusion criteria

  • Histologic or cytologic confirmed diagnosis of HCC.
  • Advanced HCC: disease not eligible for surgical and/or locoregional therapies OR progressive disease after surgical and/or locoregional therapies
  • Child-Pugh Class A
  • ECOG performance status 0-1
  • Adequate hematologic, hepatic, and renal function

Exclusion criteria

  • Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for HCC
  • History of active cardiac disease
  • Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus)
  • Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 8 weeks except for esophageal or gastric varices
  • Inability to swallow tablets or untreated malabsorption syndrome

Treatment and study plan

Brivanib

Drug

Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity

Other names: BMS-582664

Placebo

Drug

Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity

Sorafenib

Drug

Capsules, Oral, 800 mg, twice daily, Until disease progression or unacceptable toxicity

Primary outcomes

  1. To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment

    Time frame: Survival will be assessed continuously

Secondary outcomes

  1. To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria for HCC

    Time frame: Every 6 weeks

  2. To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria for HCC

    Time frame: Every 6 weeks

  3. To determine duration of response, duration of disease control, and time to response (TTR)

    Time frame: Every 6 weeks

  4. To assess the safety profile of brivanib and sorafenib

    Time frame: Every 6 weeks

  5. To explore PK and exposure-response in the study population

    Time frame: Every 6 weeks

  6. To compare time to symptomatic progression

    Time frame: Every 6 weeks

  7. To compare health-related quality of life

    Time frame: Every 6 weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Acronym: BRISK FL

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Mar 10, 2009
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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