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Vatalanib

Phase 3

Colorectal Neoplasms | Small molecule | Oncology |Novartis AG|Last Updated: Feb 10, 2020

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_CONTROLLEDBiomarker
Total Trials2
Total Enrollment2,023
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00056459Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Metastatic Colorectal Cancer.PHASE3 COMPLETED 1,168Feb 1, 2003 -Feb 10, 2020223 United States, Australia +17
NCT00056446Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal CancerPHASE3 COMPLETED 855Jan 1, 2003Jan 1, 2007Mar 6, 2017251 United States, Australia +16
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Study Endpoints
Primary Endpoints
Progression free survival
Throughout duration of study
Overall survival
throughout duration of study
Secondary Endpoints
Time to progression
Throughout duration of study
Time to treatment failure
Throughout duration of study
Best overall response rate
Throughout duration of study
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALOxaliplatin/5-FU/LV and PTK787/ZK 222584
2PLACEBO_COMPARATOROxaliplatin/5-FU/LV and placebo
Interventions
NameTypeDescription
VatalanibDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites223

Inclusion criteria: * Patients with metastatic colorectal cancer coming for initial chemotherapy * Documented metastatic colorectal cancer * WHO Performance Status of 0, 1, or 2 * Measurable tumors * Adequate hematologic status, liver and kidney function * Life expectancy greater than 12 weeks * Wr...

Countries:United StatesAustraliaBelgiumBrazilCanadaCzechiaFranceGermanyHungaryItalyNetherlandsNew ZealandPortugalSlovakiaSpainSwedenSwitzerlandTaiwanUnited KingdomAustriaHong Kong
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