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AVE0005

Phase 1

Colorectal Neoplasms | Small molecule | Oncology |Sanofi|Last Updated: Nov 9, 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 Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00921661Study of Intravenous Aflibercept in Combination With FOLFIRI in Japanese Patients With Metastatic Colorectal CancerPHASE1 COMPLETED 16Jun 1, 2009Jun 1, 2012Nov 9, 20121 Japan
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Study Endpoints
Primary Endpoints
Dose-limiting toxicity (DLT) combination with FOLFIRI
During the first 2 cycles (4 weeks) of study treatment
Secondary Endpoints
physical examination, laboratory safety tests, adverse events
up to 60 days after last treatment
Pharmacokinetics
up to 90 days after last treatment
Tumor burden, endogenous free VEGF
every 3 cycles
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AVE0005 (aflibercept)EXPERIMENTAL -
Interventions
NameTypeDescription
AVE0005 (aflibercept)DRUGIV infusion
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients with histologically or cytologically proven malignant tumor of the colon or rectum which is metastatic and inoperable. * Patients must have received at least one prior line of treatment with any standard of care, who have failed the treatment, or who have not been eli...

Countries:Japan
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