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ABI-009

Phase 1

Solid Tumors | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Oct 18, 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 Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00635284ABI-009 Trial in Patients With Advanced Non-hematologic MalignanciesPHASE1 COMPLETED 27Dec 1, 2007Jun 1, 2011Oct 18, 20192 United States
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Study Endpoints
Primary Endpoints
Determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-009 administered weekly and pharmacokinetic parameters for ABI-009.
End of Study (EOS) and Follow Up
Secondary Endpoints
Efficacy of ABI-009 in this patient population
End of Study (EOS) and Follow Up
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABI-009EXPERIMENTAL -
Interventions
NameTypeDescription
ABI-009DRUGnab-rapamycin
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: Each subject must meet the following criteria to be enrolled in this study. 1. Male and female patients with histologically or cytologically confirmed diagnosis of cancer which is not amenable to curative therapy. 2. Patients with advanced non-hematologic malignancies for whom ...

Countries:United States
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