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ABT-869

Phase 3

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

ABT-869 development status

Highest phase Phase 3 (NCT01009593)
Phase scored for ABTPhase 1
Registered trials 16 across 3 sponsors since Jun 2007

ABT-869 target and mechanism

ModalitySmall molecule

Also known as linifanib

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials3
Total Enrollment39

FDA Designations

No designations recorded

ABT-869 clinical trials

ABT-869 · 3 trials · 2 indications

Phase 1 3
NCT01381341To Compare Relative Bioavailability of Two Clinical Formulations of Linifanib.Advanced Solid Tumors
COMPLETED13 Analytics
NCT01401933Effect of Rifampin on the Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid TumorsAdvanced Solid Tumors
COMPLETED14 Analytics
NCT01114191A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Linifanib (ABT-869)Solid Tumors
COMPLETED12 Analytics
PHASE1COMPLETED
To Compare Relative Bioavailability of Two Clinical Formulations of Linifanib.
Advanced Solid TumorsUnlock trial analytics
PHASE1COMPLETED
Effect of Rifampin on the Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors
Advanced Solid TumorsUnlock trial analytics
PHASE1COMPLETED
A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Linifanib (ABT-869)
Solid TumorsUnlock trial analytics

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.

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
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 -
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
linifanibDRUGQD on Day 1 of Periods 1 and 2
RifampinDRUGQD on Days 5-16
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 to 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 10 trials (matched to "Solid Tumors")

Frequently asked questions about ABT-869

What is ABT-869 used for?

ABT-869, also known as linifanib, is an investigational small molecule being studied for the treatment of solid tumors. It is in Phase 1 clinical development for oncology indications. The drug is not yet approved and remains under investigation.

Who makes ABT-869?

ABT-869 is being developed by Abbott Laboratories, a company traded under the ticker ABT. The drug is an investigational small molecule in Phase 1 clinical development for solid tumors.

What phase is ABT-869 in?

ABT-869 is in Phase 1 clinical development. It is an investigational drug for solid tumors and has not been approved by regulatory authorities. One Phase 1 trial has been completed.

What clinical trials is ABT-869 in?

ABT-869 has one completed Phase 1 trial, NCT01114191, which assessed the effect of ketoconazole on the pharmacokinetics of linifanib (ABT-869) in 12 participants with solid tumors in the United States.

Is ABT-869 the same as linifanib?

Yes, ABT-869 is also known as linifanib. The drug is an investigational small molecule being developed by Abbott Laboratories for the treatment of solid tumors and is currently in Phase 1 clinical development.