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Linifanib

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Abbott Laboratories|Last Updated: Mar 23, 2012

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
RandomizedUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment27
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01381341To Compare Relative Bioavailability of Two Clinical Formulations of Linifanib.PHASE1 COMPLETED 13 — — May 1, 2011Dec 1, 2011Mar 23, 20121 United States
NCT01401933Effect of Rifampin on the Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid TumorsPHASE1 COMPLETED 14 — — May 1, 2011Oct 1, 2011Nov 2, 20112 United States
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Study Endpoints
Primary Endpoints
To determine the pharmacokinetic profile of linifanib in subjects with advanced or metastatic solid tumors.
At various time points from Day 1 through Day 5 of Periods 1 and 2

Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points and assayed.

To investigate the effect of rifampin on the pharmacokinetic of linifanib in subjects with advanced or metastatic solid tumors.
Blood samples for the PK of linifanib will be collected at various time points from Day 1 through Day 17.

To assess the effect of rifampin on the pharmacokinetics of linifanib and metabolite(s), an analysis will be performed for the natural logarithms of Cmax and AUC of linifanib and metabolite(s) with concentrations that permit confident determination of values of the pharmacokinetic variables. A paired t-test will be performed to compare the central value on Study Day 13 (with rifampin) to that on Study Day 1 (without rifampin). Point estimates and 90% confidence intervals will also be provided.

Secondary Endpoints
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.
Throughout the study
Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety.
Physical exam at Screening, Day 1 of Periods 1 and 2 and Day 5, Period 2/Final Visit and 30 day safety follow-up; Vital Signs (blood pressure, heart rate, body temperature) will be done at all visits.
Safety: Clinical Lab Tests will be performed for each participant as a safety measure.
Screening, Day 1, Periods 1 and 2, Day 5, Period2/Final Visit and 30 day safety follow-up.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
linifanibEXPERIMENTAL -
Interventions
NameTypeDescription
linifanibDRUGQD on Day 1 of Periods 1 and 2
RifampinDRUGQD on Days 5-16
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria 1. Age is greater than or equal to 18 years. 2. Subject must have a histologically or cytologically confirmed non-hematologic malignancy other than Hepatocellular Carcinoma (HCC). 3. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2. 4. Subject must have adequate...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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