Pazopanib and Paclitaxel for Non-Small Cell Lung Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pazopanib and Weekly Paclitaxel in Stage IIIB/IV Non-small Cell Lung Cancer|
- Objective response rate of pazopanib in combination with paclitaxel [ Time Frame: 2 years ] [ Designated as safety issue: No ]The count of individuals who sustain a complete response (CR) or a partial response (PR) for at least 4 weeks at any time during two years of treatment will be reported. A CR or PR response will be defined using standard RECIST criteria (version 1.1).
|Study Start Date:||March 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: Pazopanib plus Paclitaxel
Pazopanib daily and weekly Paclitaxel IV.
Drug: Pazopanib plus Paclitaxel
Pazopanib daily and weekly paclitaxel IV
The primary objective of this study is to evaluate the objective response rate of pazopanib in combination with paclitaxel in the treatment of subjects with advanced NSCLC. Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1). A subject is defined as a responder if he/she sustains a complete response (CR) or a partial response (PR) for at least 4 weeks at any time during treatment. A subject without a post-baseline assessment of response will be considered a non-responder.
A secondary objective of this study is to evaluate the safety and tolerability of pazopanib in combination with paclitaxel in the treatment of subjects with advanced NSCLC. Safety and tolerability endpoints will consist of the evaluation of adverse events (AEs), exposure, withdrawals due to AEs, dose reductions or interruptions, and changes from baseline in vital signs and clinical laboratory parameters.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179269
|Principal Investigator:||Danielle Shafer, DO||Loyola University|
|Principal Investigator:||Cheryl Czerlanis, MD||Loyola University|