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Trial record 1 of 2 for:    Comparison of Brivanib and Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment
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Comparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment (BRISK PS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00825955
First received: January 20, 2009
Last updated: March 3, 2017
Last verified: December 2016
  Purpose
The purpose of this study is to determine if Brivanib is an effective treatment for liver cancer in patients who have failed or could not take Sorafenib

Condition Intervention Phase
Liver Cancer
Drug: Brivanib
Other: Placebo
Procedure: Best Supportive Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib: The BRISK PS Study (Brivanib Study in HCC Patients at Risk Post Sorafenib)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To compare overall survival of subjects with advanced HCC who have progressed on/after or are intolerant to Sorafenib and receive Brivanib plus best supportive care (BSC) to those receiving placebo plus BSC [ Time Frame: computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death ]

Secondary Outcome Measures:
  • To compare time to progression (TTP) (Investigator assessed using modified Response Evaluation Criteria In Solid Tumors (RECIST) for HCC criteria) [ Time Frame: 35 months ]
  • To compare the Independent Radiological Review Committee (IRRC) assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC criteria [ Time Frame: 35 months ]
  • To assess duration of response, duration of disease control and time to response [ Time Frame: 6 weeks ]
  • To assess safety profile of brivanib. Safety will be assessed by the number of adverse events (AEs), serious adverse events (SAEs), periodic data monitoring committee (DMC) review [ Time Frame: 35 months ]

Estimated Enrollment: 414
Study Start Date: February 2009
Estimated Study Completion Date: June 2017
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brivanib Drug: Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
Other Name: BMS-582664
Procedure: Best Supportive Care
Trans-Arterial Chemo-Embolization (TACE) Therapy
Placebo Comparator: Placebo Other: Placebo
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
Procedure: Best Supportive Care
Trans-Arterial Chemo-Embolization (TACE) Therapy

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Inclusion Criteria:

  • Histologic or cytologic confirmed diagnosis of HCC
  • Advanced disease defined as (i) disease not eligible for surgical or loco-regional therapy or (ii) disease progressive after surgical or loco-regional therapy
  • Patient has failed ≥ 14 days of Sorafenib treatment
  • Cirrhotic status of Child-Pugh Class A or B with a score of 7
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
  • Subjects who have a life expectancy of at least 8 weeks
  • Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

  • women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy
  • Previous or concurrent cancer that is distinct in primary site
  • History of active cardiac disease
  • Thrombotic or embolic events within the past 6 months
  • Any other hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 4 weeks
  • Inability to swallow tablets or untreated malabsorption syndrome
  • History of human immunodeficiency virus (HIV) infection
  • Prior use of systemic investigational agents for HCC (except for Sorafenib)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825955

  Show 113 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00825955     History of Changes
Other Study ID Numbers: CA182-034
EUDRACT #: 2008-005084-34
Study First Received: January 20, 2009
Last Updated: March 3, 2017

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Liver Diseases
Sorafenib
Digestive System Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on March 22, 2017