A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer.
NCT ID: NCT00600821
Last Updated: 2013-11-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
118 participants
INTERVENTIONAL
2008-04-30
2012-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
B
Bevacizumab will be administered in combination with carboplatin and paclitaxel.
Bevacizumab
Bevacizumab is available as 100 and 400 mg preservative-free, single use vials- The starting dose is 15 mg/kg, iv infusion, every 3 weeks.
Carboplatin
Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg\*min/ml, iv infusion, every 3 weeks.
Paclitaxel
Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks
A
AG-013736 will be administered in combination with carboplatin and paclitaxel.
AG-013736 (axitinib)
AG-013736 (axitinib) is available as 1mg, and 5 mg film-coated tablets for oral administration- The starting dose is 5 mg BID-
Carboplatin
Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg\*min/ml, iv infusion, every 3 weeks.
Paclitaxel
Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bevacizumab
Bevacizumab is available as 100 and 400 mg preservative-free, single use vials- The starting dose is 15 mg/kg, iv infusion, every 3 weeks.
Carboplatin
Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg\*min/ml, iv infusion, every 3 weeks.
Paclitaxel
Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks
AG-013736 (axitinib)
AG-013736 (axitinib) is available as 1mg, and 5 mg film-coated tablets for oral administration- The starting dose is 5 mg BID-
Carboplatin
Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg\*min/ml, iv infusion, every 3 weeks.
Paclitaxel
Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* No prior treatment for lung cancer except prior adjuvant therapy if last dose was \>12 months prior to enrollment
Exclusion Criteria
* The need for blood-thinners
* Coughing up blood
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pfizer Investigational Site
Baton Rouge, Louisiana, United States
Pfizer Investigational Site
Pittsfield, Massachusetts, United States
Pfizer Investigational Site
Columbus, Mississippi, United States
Pfizer Investigational Site
Corinth, Mississippi, United States
Pfizer Investigational Site
New Albany, Mississippi, United States
Pfizer Investigational Site
Oxford, Mississippi, United States
Pfizer Investigational Site
Southaven, Mississippi, United States
Pfizer Investigational Site
Tupelo, Mississippi, United States
Pfizer Investigational Site
Lincoln, Nebraska, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Bartlett, Tennessee, United States
Pfizer Investigational Site
Germantown, Tennessee, United States
Pfizer Investigational Site
Memphis, Tennessee, United States
Pfizer Investigational Site
Memphis, Tennessee, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Lubbock, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Wenatchee, Washington, United States
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Tábor, , Czechia
Pfizer Investigational Site
Ústí nad Labem, , Czechia
Pfizer Investigational Site
Caen, , France
Pfizer Investigational Site
Paris, , France
Pfizer Investigational Site
Pierre-Bénite, , France
Pfizer Investigational Site
Bydgoszcz, , Poland
Pfizer Investigational Site
Gdansk, , Poland
Pfizer Investigational Site
Gdynia, , Poland
Pfizer Investigational Site
Torun, , Poland
Pfizer Investigational Site
Warsaw, , Poland
Pfizer Investigational Site
Alicante, Alicante, Spain
Pfizer Investigational Site
Mataró, Barcelona, Spain
Pfizer Investigational Site
Sabadell, Barcelona, Spain
Pfizer Investigational Site
Valencia, Valencia, Spain
Pfizer Investigational Site
Southampton, Hampshire, United Kingdom
Pfizer Investigational Site
Dundee, Scotland, United Kingdom
Pfizer Investigational Site
Leeds, Yorkshire, United Kingdom
Pfizer Investigational Site
Dundee, , United Kingdom
Pfizer Investigational Site
London, , United Kingdom
Pfizer Investigational Site
London, , United Kingdom
Pfizer Investigational Site
Surrey, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Twelves C, Chmielowska E, Havel L, Popat S, Swieboda-Sadlej A, Sawrycki P, Bycott P, Ingrosso A, Kim S, Williams JA, Chen C, Olszanski AJ, de Besi P, Schiller JH. Randomised phase II study of axitinib or bevacizumab combined with paclitaxel/carboplatin as first-line therapy for patients with advanced non-small-cell lung cancer. Ann Oncol. 2014 Jan;25(1):132-8. doi: 10.1093/annonc/mdt489.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A4061030
Identifier Type: -
Identifier Source: org_study_id