Study of ABT-869 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of the ABT-869 on the NSCLC subjects.

Official Title
-----------------
An Open-Label, Randomized, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Conditions
-----------------
Non-Small Cell Lung Cancer (NSCLC)

Intervention / Treatment
-----------------
* Drug: ABT-869 .25 mg/kg
* Drug: ABT-869 0.10 mg/kg


Participation Criteria
=================
Eligibility Criteria
-----------------
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%

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-869 0.25 mg/kg<br>Approximately half of the subjects were randomized to receive the high dose | Drug: ABT-869 .25 mg/kg<br>* 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.<br>|
| Experimental: ABT-869 0.10 mg/kg<br>Approximately half of the subjects were randomized to receive the Low Dose | Drug: ABT-869 0.10 mg/kg<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Rate (PFR) |  | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate |  | Week 16 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Refractory, Metastatic