Study of Carboplatin/Paclitaxel in Combination With ABT-869 in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Advanced or Metastatic Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00716534
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A ABT-869 12.5 mg ABT-869 + Carboplatin/Paclitaxel A Carboplatin 12.5 mg ABT-869 + Carboplatin/Paclitaxel B ABT-869 7.5 mg ABT-869 + Carboplatin/Paclitaxel B Carboplatin 7.5 mg ABT-869 + Carboplatin/Paclitaxel B Paclitaxel 7.5 mg ABT-869 + Carboplatin/Paclitaxel C Placebo for ABT-869 Placebo (7.5 mg or 12.5 mg) + Carboplatin/Paclitaxel C Carboplatin Placebo (7.5 mg or 12.5 mg) + Carboplatin/Paclitaxel A Paclitaxel 12.5 mg ABT-869 + Carboplatin/Paclitaxel C Paclitaxel Placebo (7.5 mg or 12.5 mg) + Carboplatin/Paclitaxel
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Disease Progression
- Secondary Outcome Measures
Name Time Method Overall survival, best response rate, time to tumor progression, objective response rate, best percent change in tumor size, duration of response Disease Progression Survival Rate 12 Months
Trial Locations
- Locations (37)
Site Reference ID/Investigator# 13101
🇺🇸Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 24122
🇺🇸Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 22684
🇧🇷Santo Andre, Brazil
Site Reference ID/Investigator# 19043
🇦🇺Woodville South, Australia
Site Reference ID/Investigator# 15848
🇺🇸Greensboro, North Carolina, United States
Site Reference ID/Investigator# 23682
🇦🇺Cairns, Australia
Site Reference ID/Investigator# 15851
🇺🇸Lansing, Michigan, United States
Site Reference ID/Investigator# 19042
🇦🇺Bedford Park, Australia
Site Reference ID/Investigator# 15601
🇧🇷Porto Alegre, Brazil
Site Reference ID/Investigator# 22444
🇺🇸Canton, Ohio, United States
Site Reference ID/Investigator# 15844
🇺🇸Lebanon, New Hampshire, United States
Site Reference ID/Investigator# 15850
🇺🇸Chandler, Arizona, United States
Site Reference ID/Investigator# 21862
🇦🇺Lismore, Australia
Site Reference ID/Investigator# 23522
🇧🇷Porto Alegre, Brazil
Site Reference ID/Investigator# 22443
🇺🇸Hackensack, New Jersey, United States
Site Reference ID/Investigator# 7179
🇺🇸Atlanta, Georgia, United States
Site Reference ID/Investigator# 17703
🇧🇷Jau, Brazil
Site Reference ID/Investigator# 17704
🇧🇷Rio de Janeiro, Brazil
Site Reference ID/Investigator# 18963
🇨🇿Olomouc, Czech Republic
Site Reference ID/Investigator# 15846
🇺🇸Peoria, Arizona, United States
Site Reference ID/Investigator# 26842
🇺🇸Hershey, Pennsylvania, United States
Site Reference ID/Investigator# 22504
🇨🇿Nachod, Czech Republic
Site Reference ID/Investigator# 23582
🇧🇷Sao Paulo, Brazil
Site Reference ID/Investigator# 17702
🇧🇷Sao Paulo, Brazil
Site Reference ID/Investigator# 19022
🇨🇿Pribram V, Czech Republic
Site Reference ID/Investigator# 18962
🇨🇿Prague 2, Czech Republic
Site Reference ID/Investigator# 38003
🇷🇺Kazan, Russian Federation
Site Reference ID/Investigator# 23312
🇷🇺Moscow, Russian Federation
Site Reference ID/Investigator# 18961
🇸🇬Singapore, Singapore
Site Reference ID/Investigator# 18064
🇷🇺Moscow, Russian Federation
Site Reference ID/Investigator# 18066
🇷🇺Moscow, Russian Federation
Site Reference ID/Investigator# 18065
🇷🇺Moscow, Russian Federation
Site Reference ID/Investigator# 38260
🇷🇺Kirov, Russian Federation
Site Reference ID/Investigator# 23562
🇷🇺St. Petersburg, Russian Federation
Site Reference ID/Investigator# 18964
🇨🇿Kyjov, Czech Republic
Site Reference ID/Investigator# 15841
🇺🇸Miami, Florida, United States
Site Reference ID/Investigator# 15847
🇺🇸Cleveland, Ohio, United States