Recent Updates
Recently added Catalysts

linifanib

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |AbbVie Inc.|Last Updated: Nov 21, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01413893An Extension Study of Linifanib (ABT-869) in Subjects With Advanced or Metastatic Solid TumorsPHASE1 COMPLETED 35Jun 1, 2011Jun 1, 2012Nov 21, 2017 -
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.
All adverse events occuring through the Final Visit will be reported.

The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study. The investigators will question each subject regarding any adverse effects that they have experienced and record any events on the care report forms. All adverse events will be followed to a satisfactory clinical resolution.

Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety.
Change from baseline to Day 1 of Weeks 1, 2, 3, 6, 9 and 12 and on Week 24 then Day 1 of every 12 weeks and Final Visit.

Physical exam, blood pressure, pulse, body temperature will be measured and recorded on the case report forms.

Safety: Multiple Gated Acquisition (MUGA) will be assessed at specified time points as a measure of safety.
Change from baseline to every 12 weeks

MUGA

Safety: Clinical Lab Tests will be performed for each participant as a safety measure.
Change from baseline to Day 1 of Weeks 1, 2, 3, 6, 9 and 12 and on Week 24 then Day 1 of every 12 weeks and Final Visit

Chemistry, hematology, urinalysis lab tests will be measured and recorded on the case report forms. All clinically significant values will be followed by the investigator to a satisfactory clinical resolution.

Secondary Endpoints
There are no secondary outcome measures specified for this study.
There are no secondary outcome measures specified for this study.
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
linifanibEXPERIMENTAL -
Interventions
NameTypeDescription
linifanibDRUGQD daily
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria 1. Subject has completed a previous study utilizing linifanib (per the criteria in the previous study) or was active and assigned to linifanib when the study was completed and the investigator believes that continued treatment with linifanib is in the best interest of the subject...

Unlock Eligibility Criteria