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ABI-007

Phase 3

Breast Neoplasms | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Dec 15, 2016

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
RandomizedUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment560
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00046527Study of ABI-007 and Taxol in Patients With Metastatic Breast CancerPHASE3 COMPLETED 460Jun 1, 2001 -Jul 13, 20061 United States
NCT00046514ABI-007 in Taxol Resistant Patients With Metastatic Breast CancerPHASE2 COMPLETED 100Jun 1, 2001 -Dec 15, 20161 United States
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
ABI-007DRUG -
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Eligibility Criteria
Age Range16 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Patients will be eligible for this trial if: * Female, non-pregnant, non-lactating, and, if of child-bearing potential, have a negative serum pregnancy test, and use approved contraception * Sixteen years of age or older * Histologically or cytologically confirmed breast cancer (stage III or IV) wi...

Countries:United States
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