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ABT-348

Phase 1

Acute Lymphoblastic Leukemia | Small molecule | Oncology |AbbVie Inc.|Last Updated: Nov 20, 2017

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01110473ABT-348 as Monotherapy and in Combination With Azacitidine to Treat Advanced Hematologic MalignanciesPHASE1 COMPLETED 52 — — Apr 1, 2010Jun 1, 2013Nov 20, 20173 United States
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Study Endpoints
Primary Endpoints
Determine the safety profile (adverse events by toxicity grade and relationship to study drug, serious adverse events, adverse events leading to discontinuation and relevant clinical laboratory abnormalities) of ABT-348 as monotherapy or in combination
At each treatment visit
Study the pharmacokinetic interaction (plasma concentrations and pharmacokinetic parameter values) of ABT-348 as monotherapy and in combination
At study visits
Secondary Endpoints
Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RPTD) of ABT-348 when administered as a monotherapy and in combination in subjects with advanced hematologic malignancies
At each treatment visit
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Monotherapy, once dailyEXPERIMENTAL -
Monotherapy, twice dailyEXPERIMENTAL -
Combination with AzacitidineEXPERIMENTAL -
IV monotherapy, once dailyEXPERIMENTAL -
Interventions
NameTypeDescription
ABT-348DRUGAn oral dose of ABT-348, once daily on Day 1, Day 8, and Day 15 of each 28 day cycle.
ABT-348 and azacitidineDRUGAn oral dose of ABT-348 on Day 1, Day 8, and Day 15 of each 28 day cycle. An IV or injection of azacitidine on Days 1-7 of each 28 day cycle.
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Histological or cytological confirmation of one of the following (Arms A, B and D): * Relapsed or refractory acute myelogenous leukemia (AML), untreated AML in subjects who are \> 60 years of age and do not have favorable cytogenetics (i.e., lack t(8,21) or inv(16)/t(16,1...

Countries:United States
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