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AVE8062

Phase 1

Advanced Neoplastic Disease | Small molecule | Other |Sanofi|Last Updated: Jul 25, 2013

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 Enrollment58
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01907685Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Docetaxel in Patients With Advanced Solid TumorsPHASE1 COMPLETED 58 — — Jun 1, 2006Feb 1, 2011Jul 25, 2013 - —
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Study Endpoints
Primary Endpoints
Number of Participants With Dose Limiting Toxicities (DLTs)
3 weeks (cycle 1)
Secondary Endpoints
Number of Participants with Adverse Events
Up to disease progression or unacceptable toxicity or study discontinuation criteria (median treatment of 4 cycles)
Plasma concentration of AVE8062 and its metabolite
Before AVE8062 infusion, immediately prior to the end of AVE8062 infusion, 5, 10, 25, 45 and 60 minutes then 2, 4, 6, 8-10 and 24 hours post AVE8062 infusion (cycle 1)
Plasma concentration of docetaxel
Before docetaxel infusion (corresponding to 24 hours post AVE8062 infusion), 15 minutes before the end of docetaxel infusion, 15 and 45 minutes post docetaxel infusion (cycle 1)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AVE8062 / DocetaxelEXPERIMENTALAVE8062 30-minute IV, 11.5 to 42 mg/m2, followed by Docetaxel, 1-hour IV, 75 and 100 mg/m2 in 3-week cycles until disease progression or unacceptable toxicity or study discontinuation criteria
Interventions
NameTypeDescription
AVE8062DRUGPharmaceutical form:Solution for infusion Route of administration: Intravenous
DocetaxelDRUGPharmaceutical form: solution for infusion Route of administration: Intravenous
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo

Inclusion criteria: * Advanced neoplastic disease (i.e metastatic or locally advanced disease) for which docetaxel-based regimen therapy is indicated such as breast, non-small cell lung and prostate cancer. * ECOG performance status of 0 to 1. Exclusion criteria: * Concurrent treatment with any o...

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