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Erbitux

Phase 2

Colorectal Neoplasms | Monoclonal antibody | Oncology |Eli Lilly and Company|Last Updated: Feb 23, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment250
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00044863Study of Erbitux (Cetuximab) in Patients With Metastatic Colorectal CarcinomaPHASE2 COMPLETED 250Aug 1, 2002Dec 1, 2005Feb 23, 20111 United States
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Study Endpoints
Primary Endpoints
Determine the response rate of cetuximab in patients with EGFR-positive, metastatic carcinoma
every 6 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALPatients with metastatic EGFR-positive colorectal carcinoma
Interventions
NameTypeDescription
Erbitux (Cetuximab)BIOLOGICAL400 mg/m2 initial dose, 250 mg/m2 weekly
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Provided signed written informed consent. * Histologically- or pathologically- confirmed metastatic colorectal carcinoma; * Documented progressive disease after receiving either: 1. at least two chemotherapy regimens for metastatic disease or 2. adjuvant therapy plus one ...

Countries:United States
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