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First Line Hepato Cellular Carcinoma (HCC) (BRISK FL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00858871
First received: March 9, 2009
Last updated: October 14, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Hepato Cellular Carcinoma (HCC) Drug: Brivanib Drug: Placebo Drug: Sorafenib Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria for HCC [ Time Frame: Every 6 weeks ]
  • 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 ]
  • To determine duration of response, duration of disease control, and time to response (TTR) [ Time Frame: Every 6 weeks ]
  • To assess the safety profile of brivanib and sorafenib [ Time Frame: Every 6 weeks ]
  • To explore PK and exposure-response in the study population [ Time Frame: Every 6 weeks ]
  • To compare time to symptomatic progression [ Time Frame: Every 6 weeks ]
  • To compare health-related quality of life [ Time Frame: Every 6 weeks ]

Enrollment: 1714
Study Start Date: May 2009
Study Completion Date: September 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Brivanib Drug: Brivanib
Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity
Other Name: BMS-582664
Drug: Placebo
Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity
Active Comparator: Sorafenib Drug: Sorafenib
Capsules, Oral, 800 mg, twice daily, Until disease progression or unacceptable toxicity
Drug: Placebo
Tablets, Oral, Once Daily, Until disease progression or unacceptable toxicity

  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 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
  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: NCT00858871

  Show 173 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: NCT00858871     History of Changes
Other Study ID Numbers: CA182-033
EUDRACT # 2008-003533-24
Study First Received: March 9, 2009
Last Updated: October 14, 2016

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 28, 2017