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ABI-008

Phase 1

Hormone Refractory Prostate Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 22, 2019

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 Enrollment102
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00477529ABI-008 Trial in Patients With Hormone-refractory Prostate CancerPHASE1 COMPLETED 102Apr 1, 2007Jun 2, 2011Nov 22, 20194 United States
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Study Endpoints
Primary Endpoints
DLT's and MTD's
1 Year
Secondary Endpoints
Efficacy of ABI-008 in this patient population
Q12 weeks and End of Study (EOS) and Follow Up
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABI-008EXPERIMENTAL -
Interventions
NameTypeDescription
ABI-008DRUGnab-docetaxel
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: Each subject must meet the following criteria to be enrolled in this study. 1. Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate that is clinically refractory to hormone therapy. 2. Zubrod Performance Status 0-1. 3. At the time of enrol...

Countries:United States
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