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OMBRABULIN

Phase 3

Sarcoma | Small molecule | Oncology |Sanofi|Last Updated: Dec 21, 2015

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 Enrollment355
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00699517A Study of AVE8062 in Advanced-stage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide ChemotherapiesPHASE3 COMPLETED 355Jun 1, 2008Apr 1, 2013Dec 21, 201545 United States, Belgium +8
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Study Endpoints
Primary Endpoints
Progression free survival
until event or study cut-off date (Tumor assessment every 6 weeks)
Secondary Endpoints
Overall survival
until event or study cut-off date
Response rate
tumor assessment every 6 weeks
Safety profile
assessment every 3 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
OMBRABULIN (AVE8062)DRUGI.V. infusion followed by administration of cisplatin
PlaceboDRUGI.V. infusion followed by administration of cisplatin
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites45

Inclusion criteria: * Histologically proven soft tissue sarcoma * Unresectable locoregional recurrent or metastatic soft tissue sarcoma * Failure of a previous anthracycline-based regimen administered recommended dose and of prior ifosfamide therapy Exclusion criteria: * Less than 3 weeks elapsed...

Countries:United StatesBelgiumBrazilFranceHungaryIndiaItalySerbiaSpainUnited Kingdom
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