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

Phase 2

Completed

• Conditions: Non-Small Cell Lung Cancer (NSCLC)
• Interventions: Drug: ABT-869 .25 mg/kg; Drug: ABT-869 0.10 mg/kg

• Registration Number: NCT00517790
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

The purpose of this study is to evaluate the effect of the ABT-869 on the NSCLC subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-16
• Study First Submitted QC: 2007-08-16
• Study First Posted: 2007-08-17
• Primary Completion: 2011-06
• Study Completion: 2012-06
• Disposition First Submitted: 2012-07-13
• Disposition First Submitted QC: 2012-07-13
• Disposition First Posted: 2012-07-23
• Status Verified: 2013-01
• Last Update Submitted: 2013-03-29
• Last Update Posted: 2013-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABT-869 0.25 mg/kg	ABT-869 .25 mg/kg	Approximately half of the subjects were randomized to receive the high dose
ABT-869 0.10 mg/kg	ABT-869 0.10 mg/kg	Approximately half of the subjects were randomized to receive the Low Dose

Primary Outcome Measures

Name	Time	Method
Progression Free Rate (PFR)	Week 16

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	Week 16

Trial Locations

Locations (28)

Site Reference ID/Investigator# 7194; 🇺🇸 Fountain Valley, California, United States

Site Reference ID/Investigator# 6739; 🇺🇸 Evanston, Illinois, United States

Site Reference ID/Investigator# 6042; 🇺🇸 St. Louis, Missouri, United States

Site Reference ID/Investigator# 5603; 🇺🇸 Voorhees, New Jersey, United States

Site Reference ID/Investigator# 6777; 🇺🇸 Greensboro, North Carolina, United States

Site Reference ID/Investigator# 5663; 🇨🇳 Taichung, Taiwan

Site Reference ID/Investigator# 5534; 🇸🇬 Singapore, Singapore

Site Reference ID/Investigator# 5617; 🇺🇸 Los Angeles, California, United States

Site Reference ID/Investigator# 6627; 🇺🇸 Waterbury, Connecticut, United States

Site Reference ID/Investigator# 8100; 🇺🇸 Harvey, Illinois, United States

Site Reference ID/Investigator# 7616; 🇺🇸 Port St. Lucie, Florida, United States

Site Reference ID/Investigator# 7868; 🇺🇸 Newark, Delaware, United States

Site Reference ID/Investigator# 5652; 🇺🇸 Buffalo, New York, United States

Site Reference ID/Investigator# 6680; 🇺🇸 East Orange, New Jersey, United States

Site Reference ID/Investigator# 5650; 🇺🇸 Memphis, Tennessee, United States

Site Reference ID/Investigator# 6040; 🇨🇦 Barrie, Canada

Site Reference ID/Investigator# 5275; 🇨🇦 Ottawa, Canada

Site Reference ID/Investigator# 7756; 🇫🇷 Marseille cedex 09, France

Site Reference ID/Investigator# 6572; 🇨🇦 Toronto, Canada

Site Reference ID/Investigator# 8069; 🇫🇷 Villejuif, France

Site Reference ID/Investigator# 8068; 🇫🇷 Toulouse, France

Site Reference ID/Investigator# 5660; 🇸🇬 Singapore, Singapore

Site Reference ID/Investigator# 5640; 🇨🇳 Taipei, Taiwan

Site Reference ID/Investigator# 6184; 🇺🇸 Charlotte, North Carolina, United States

Site Reference ID/Investigator# 5646; 🇺🇸 Aurora, Colorado, United States

Site Reference ID/Investigator# 5648; 🇺🇸 Chicago, Illinois, United States

Site Reference ID/Investigator# 7934; 🇺🇸 Sacramento, California, United States

Site Reference ID/Investigator# 5269; 🇺🇸 Indianapolis, Indiana, United States