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Brivanib

Phase 3

Hepatocellular Carcinoma | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Dec 2, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment751
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00908752Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCCPHASE3 COMPLETED 734 — — Jul 20, 2009Jan 26, 2018Dec 2, 201994 United States, Argentina +11
NCT01540461Determine the Pharmacokinetics and Safety of Brivanib in Chinese Subjects With Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)PHASE1 COMPLETED 17 — — Mar 1, 2012Nov 1, 2013Jul 8, 20143 China
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Study Endpoints
Primary Endpoints
To compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy
Survival will be assessed continuously
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 Endpoints
To compare the Time-To-Disease Progression (TTDP) of patients receiving brivanib with TACE therapy to that of patients receiving placebo with TACE therapy
Every 8 weeks
To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms
Every 8 weeks
To determine the total number of TACE sessions in the brivanib and placebo arms and to compare the rate of TACE sessions in the brivanib and placebo arms
End of Study
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BrivanibACTIVE_COMPARATORAdjuvant treatment with TACE Therapy
Brivanib PlaceboPLACEBO_COMPARATORPlacebo adjuvant treatment with TACE Therapy
Arm: BrivanibEXPERIMENTAL -
Interventions
NameTypeDescription
BrivanibDRUGTablets, Oral, 200 mg, once daily, until disease progression or toxicity
Brivanib PlaceboOTHERTablets, Oral, 0 mg, once daily, until disease progression or toxicity
TACE TherapyPROCEDURETrans-Arterial Chemo-Embolization Therapy
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites94

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Patients with diagnosis of hepatocellular carcinoma * Cirrhotic status of Child-Pugh Class A or B with a score of 7 * ECOG performance status of 0 or 1 * Adequate hematologi...

Countries:United StatesArgentinaAustraliaCanadaChinaFranceHong KongItalyJapanSouth KoreaSpainTaiwanThailand
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