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ABT-869

Phase 1

Solid Tumors | Small molecule | Oncology |Abbott Laboratories|Last Updated: Jul 26, 2011

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 Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01114191A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Linifanib (ABT-869)PHASE1 COMPLETED 12May 1, 2010Feb 1, 2011Jul 26, 20112 United States
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Study Endpoints
Primary Endpoints
To investigate the effect of ketoconazole on the pharmacokinetics of ABT-869 in subjects with advanced or metastatic solid tumors.
Different timepoints on Days 1-12

Blood samples for the PK of ABT-869 and ketoconazole will be collected at designated time points throughout the study.

Secondary Endpoints
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.
Throughout the study
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Interventions
NameTypeDescription
ABT-869DRUG2.5mg \[5 mg days 1, 8 and 12. 17.5 mg on days 13 and after\]
ketoconazoleDRUG400 mg days 6-11
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria 1. Male or female and age is \>= 18 years. 2. Must have a histologically or cytologically confirmed non-hematologic malignancy. 3. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2. 4. Must have adequate bone marrow, renal and hepatic function as follows: * B...

Countries:United States
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