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Linifanib

Phase 1

Non-Small Cell Lung Cancer | Small molecule | Oncology |AbbVie Inc.|Last Updated: Nov 21, 2017

Success Probability

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Linifanib · 2 trials · 2 indications

Phase 1 2
NCT01413893An Extension Study of Linifanib (ABT-869) in Subjects With Advanced or Metastatic Solid TumorsAdvanced Solid Tumors
COMPLETED35 Analytics
NCT01225302A Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Non-Small Cell Lung Cancer (NSCLC)Non-Small Cell Lung Cancer
COMPLETED12 Analytics
PHASE1COMPLETED
An Extension Study of Linifanib (ABT-869) in Subjects With Advanced or Metastatic Solid Tumors
Advanced Solid TumorsUnlock trial analytics
PHASE1COMPLETED
A Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Non-Small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung CancerUnlock trial analytics

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.

Safety (Number of patients with adverse events and/or dose-limiting toxicities)
At each treatment visit (weekly for 6 weeks, then every 3 weeks)

Evaluation of vital signs, physical exams, clinical lab testing and adverse event monitoring.

Secondary Endpoints

There are no secondary outcome measures specified for this study.
There are no secondary outcome measures specified for this study.
Preliminary tumor response
Week 6
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
linifanibEXPERIMENTAL -
Arm AEXPERIMENTAL -
Arm BEXPERIMENTAL -

Interventions

NameTypeDescription
linifanibDRUGQD daily
CarboplatinDRUGGiven on Day 1 of every 21-day cycle
PaclitaxelDRUGGiven on Day 1 of every 21-day cycle
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Eligibility Criteria

Age Range18 Years to 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...

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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about Linifanib

What is Linifanib used for?

Linifanib is an investigational small molecule being studied for the treatment of advanced solid tumors and non-small cell lung cancer. It is being developed by AbbVie Inc. and is currently in Phase 1 clinical development.

What does Linifanib target?

Linifanib is a small molecule that targets receptor tyrosine kinases, including vascular endothelial growth factor receptor and platelet-derived growth factor receptor. These targets are involved in tumor angiogenesis and growth.

Who makes Linifanib?

Linifanib is being developed by AbbVie Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol ABBV.

What phase is Linifanib in?

Linifanib is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy.

What clinical trials is Linifanib in?

Linifanib has been studied in two completed Phase 1 trials. NCT01225302 evaluated linifanib in combination with carboplatin and paclitaxel in Japanese subjects with non-small cell lung cancer. NCT01413893 was an extension study in subjects with advanced or metastatic solid tumors.

Is Linifanib the same as ABT-869?

Yes, Linifanib is also known as ABT-869. Clinical trial records refer to the drug as linifanib (ABT-869), confirming that these names refer to the same investigational agent.