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mapatumumab

Phase 1

Hepatocellular Carcinoma | Monoclonal antibody | Oncology |GSK plc|Last Updated: Oct 30, 2012

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00712855A Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular CarcinomaPHASE1 COMPLETED 23Jun 1, 2008Aug 1, 2012Oct 30, 20126 United States
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Study Endpoints
Primary Endpoints
Type, frequency, and severity of adverse events.
Until disease progression or unacceptable toxicity develops
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTALmapatumumab and sorafenib
Interventions
NameTypeDescription
mapatumumabBIOLOGICAL3, 10, or 30 mg/kg IV (in the vein), on day 1 of each 21 day cycle
sorafenibDRUG400 mg orally, twice a day continuously in each cycle
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Moderate liver disease * Test positive for hepatitis B surface antigen or hepatitis C antibody * Locally advanced unresectable/untransplantable or metastatic hepatocellular carcinoma * Age 18 years or older Exclusion Criteria: * Received investigational (not yet approved by ...

Countries:United States
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