Status:
COMPLETED
Study of Carboplatin/Paclitaxel in Combination With ABT-869 in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Advanced or Metastatic Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is designed to determine the clinical efficacy and toxicity of ABT-869 in combination with carboplatin and paclitaxel in the treatment of subjects with advanced or metastatic NSCLC.
Eligibility Criteria
Inclusion
- Subject must be at least 18 years of age.
- Subject must have cytologically or histologically confirmed non-squamous NSCLC
- Subject must have recurrent or advanced (Stage IIIb with pleural or pericardial effusion) or metastatic (Stage IV) disease that is not amenable to surgical resection or radiation with curative intent.
- Subject has measurable disease, defined as at least 1 unidimensional measurable lesion on a computed tomography (CT) scan as defined by RECIST (for subjects in the randomized portion only).
- Subject has an ECOG Performance Score of 0-1.
- Willing to take adequate measures to prevent pregnancy.
Exclusion
- The subject has NSCLC with a predominant squamous cell histology
- Subject has hypersensitivity to paclitaxel.
- Subject has received any anti-cancer therapy for treatment of NSCLC.
- Subject has received radiation therapy within 21 days of Study Day 1.
- Subject has had major surgery within 21 days.
- Subject has untreated brain or meningeal metastases.
- Subject is receiving therapeutic anticoagulation therapy.
- Subject has a central thoracic tumor lesion as defined by location within the hilar structures.
- Subject has proteinuria CTC Grade \> 1 at baseline.
- Subject has a history of, or currently exhibits clinically significant cancer related events of bleeding.
- The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) \> 90 mm Hg or systolic BP \> 140 mm Hg.
- The subject has a history of myocardial infarction, stroke or Transient Ischemic Attack (TIA) within 6 months of Study Day 1.
- The subject has a documented left ventricular (LV) ejection fraction \< 50%.
- The subject has known autoimmune disease with renal involvement (i.e., lupus).
- The subject is receiving combination anti-retroviral therapy for HIV.
- The subject has clinically significant uncontrolled condition(s).
- The subject has a history of another active cancer within the past 5 years.
- The subject has active ulcerative colitis, Crohn's disease, celiac disease or any other conditions that interfere with absorption.
- The subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.
- The subject is pregnant or breast feeding.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00716534
Start Date
June 1 2008
End Date
April 1 2012
Last Update
April 29 2013
Active Locations (37)
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1
Site Reference ID/Investigator# 15850
Chandler, Arizona, United States, 85224
2
Site Reference ID/Investigator# 15846
Peoria, Arizona, United States, 85381
3
Site Reference ID/Investigator# 15841
Miami, Florida, United States, 33136
4
Site Reference ID/Investigator# 7179
Atlanta, Georgia, United States, 30322