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Adecatumumab

Phase 2

Liver Metastases | Small molecule | Oncology |Amgen Inc.|Last Updated: Nov 11, 2011

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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00866944Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver MetastasesPHASE2 COMPLETED 35Mar 1, 2009Nov 1, 2011Nov 11, 201116 France, Germany
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Study Endpoints
Primary Endpoints
Disease free survival rate (DFS)
1 year
Secondary Endpoints
time to relapse
1 year
Incidence of AEs
1 year
Quality of Life
1 year
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAdecatumumab alone
2EXPERIMENTALFOLFOX 4 followed by Adecatumumab
3ACTIVE_COMPARATORFOLFOX 4 alone
Interventions
NameTypeDescription
AdecatumumabDRUGAdecatumumab,6-9mg/kg, every 14 days, 24 cycles
Adecatumumab and FOLFOXDRUGFOLFOX 4, every 14 days, 12 cycles followed by Adecatumumab, 6-9mg/kg, every 14 days, 12 cycles
FOLFOX 4DRUGFOLFOX 4, every 14 days, 12 cycles
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Histopathologically confirmed complete resection (R0) of liver metastases from colorectal adenocarcinoma * Age ≥18 years * ECOG performance status ≤ 2 * Patient was informed, has read and understood the patient information / informed consent form and has given written informed...

Countries:FranceGermany
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