Non-Small Cell Lung Cancer (NSCLC)
Conditions
Keywords
Refractory, Metastatic
Brief summary
The purpose of this study is to evaluate the effect of the ABT-869 on the NSCLC subjects.
Interventions
DRUGABT-869 .25 mg/kg
Subjects 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.
DRUGABT-869 0.10 mg/kg
Subjects 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.
Sponsors
Genentech, Inc.
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 Oncology Group (ECOG) Performance status of 0-2 * Subject has received at least one prior line of systemic treatment but no more than two treatment regimen(s) for advanced or metastatic NSCLC. In addition, the subject may have received systemic neo-adjuvant or adjuvant chemotherapy for NSCLC * Adequate organ function
Exclusion criteria
* Subject has received targeted VEGF/PDGF TKI (tyrosine kinase inhibitor) therapy. Prior Avastin is allowed. * Subject has untreated brain or meningeal metastases. * History of greater than 10% weight loss * Subject has clinically relevant hemoptysis * The subject has proteinuria CTC Grade \> 1 * The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure \> 100 mmHg or systolic blood pressure \> 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention. * The subject has a documented left ventricular ejection fraction \< 50%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Rate (PFR) | Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate | Week 16 |
Countries
Canada, France, Singapore, Taiwan, United States
Outcome results
None listed