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ABT-869/kg

Phase 2

Non-Small Cell Lung Cancer (NSCLC) | Small molecule | Oncology |AbbVie Inc.|Last Updated: Apr 5, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment140

FDA Designations

No designations recorded

Clinical trial landscape

ABT-869/kg · 1 trial · 1 indication

Phase 2 1
NCT00517790Study of ABT-869 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)Non-Small Cell Lung Cancer (NSCLC)
COMPLETED140 Analytics
PHASE2COMPLETED
Study of ABT-869 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung Cancer (NSCLC)Unlock trial analytics

Study Endpoints

Primary Endpoints

Progression Free Rate (PFR)
Week 16

Secondary Endpoints

Objective Response Rate
Week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABT-869 0.25 mg/kgEXPERIMENTALApproximately half of the subjects were randomized to receive the high dose
ABT-869 0.10 mg/kgEXPERIMENTALApproximately half of the subjects were randomized to receive the Low Dose

Interventions

NameTypeDescription
ABT-869 .25 mg/kgDRUGSubjects will take linifanib (ABT-869) based on body weight. Dosing will be determined at baseline and will be based on randomization to either 0.10 mg or 0.25 mg of ABT-869 per kilogram of body weight.
ABT-869 0.10 mg/kgDRUGSubjects will take linifanib (ABT-869) based on body weight. Dosing will be determined at baseline and will be based on randomization to either 0.10 mg or 0.25 mg of ABT-869 per kilogram of body weight.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Subject must be histologically or cytologically diagnosed with advanced or metastatic NSCLC * Subjects must have at least one lesion measurable by CT scan as defined by RECIST * The measurable lesion may have not received radiation therapy * Subject has an Eastern Cooperative ...

Countries:United StatesCanadaFranceSingaporeTaiwan
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Frequently asked questions about ABT-869/kg

What is ABT-869 used for?

ABT-869 is an investigational small molecule being studied in oncology. It has been evaluated in clinical trials for advanced renal cell carcinoma, advanced non-small cell lung cancer (NSCLC), advanced or metastatic NSCLC, advanced solid tumors, advanced colorectal cancer, and metastatic breast cancer. It is not approved and remains in clinical development.

Who is developing ABT-869?

ABT-869 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug has completed Phase 2 trials in oncology indications.

What phase is ABT-869 in?

ABT-869 has completed Phase 2 clinical trials. It is an investigational drug and has not been approved by regulatory authorities. Its development status is based on completed trials in advanced renal cell carcinoma and non-small cell lung cancer.

What clinical trials has ABT-869 been in?

ABT-869 has been studied in several completed trials. NCT00486538 evaluated it in advanced renal cell carcinoma after sunitinib treatment. NCT00517790 studied it in advanced NSCLC. NCT00716534 tested it with carboplatin and paclitaxel in advanced or metastatic NSCLC. NCT00733187 examined food effects and diurnal variation in advanced solid tumors.

Is ABT-869 the same as linifanib?

ABT-869 is also known by the name linifanib. The drug has been referred to by both names in clinical research contexts. It is an investigational small molecule oncology agent developed by AbbVie.