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ABT-869 /kg

Phase 2

Non-Small Cell Lung Cancer (NSCLC) | Small molecule | Oncology |AbbVie Inc.|Last Updated: Apr 5, 2013

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment140
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00517790Study of ABT-869 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)PHASE2 COMPLETED 140Aug 1, 2007Jun 1, 2012Apr 5, 201328 United States, Canada +3
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Study Endpoints
Primary Endpoints
Progression Free Rate (PFR)
Week 16
Secondary Endpoints
Objective Response Rate
Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABT-869 0.25 mg/kgEXPERIMENTALApproximately half of the subjects were randomized to receive the high dose
ABT-869 0.10 mg/kgEXPERIMENTALApproximately half of the subjects were randomized to receive the Low Dose
Interventions
NameTypeDescription
ABT-869 .25 mg/kgDRUGSubjects will take linifanib (ABT-869) based on body weight. Dosing will be determined at baseline and will be based on randomization to either 0.10 mg or 0.25 mg of ABT-869 per kilogram of body weight.
ABT-869 0.10 mg/kgDRUGSubjects will take linifanib (ABT-869) based on body weight. Dosing will be determined at baseline and will be based on randomization to either 0.10 mg or 0.25 mg of ABT-869 per kilogram of body weight.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Subject must be histologically or cytologically diagnosed with advanced or metastatic NSCLC * Subjects must have at least one lesion measurable by CT scan as defined by RECIST * The measurable lesion may have not received radiation therapy * Subject has an Eastern Cooperative ...

Countries:United StatesCanadaFranceSingaporeTaiwan
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