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Xilonix

Phase 3

Symptomatic Colorectal Cancer | Monoclonal antibody | Oncology |Johnson & Johnson|Last Updated: Mar 1, 2021

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 Trials1
Total Enrollment276
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02138422A Phase 3 Study to Evaluate Xilonix as an Anticancer Therapy in Patients With Symptomatic Colorectal CancerPHASE3 COMPLETED 276Jul 31, 2014Nov 30, 2015Mar 1, 20211 Poland
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Study Endpoints
Primary Endpoints
Response Rate
8 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo administered intravenously every 2 weeks
XilonixACTIVE_COMPARATORXilonix administered intravenously every 2 weeks
Interventions
NameTypeDescription
XilonixBIOLOGICAL -
PlaceboBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Subjects with pathologically confirmed colorectal carcinoma that is metastatic or unresectable and which is refractory to standard therapy. To be considered refractory, a subject must have failed both an oxaliplatin (oxaliplatin may have been in the adjuvant setting) and an i...

Countries:Poland
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