Pazopanib and Paclitaxel for Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT01179269|
Recruitment Status : Withdrawn (The study was stopped because the research team was unable to enroll any participants)
First Posted : August 11, 2010
Last Update Posted : October 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Pazopanib plus Paclitaxel||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pazopanib and Weekly Paclitaxel in Stage IIIB/IV Non-small Cell Lung Cancer|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Experimental: Pazopanib plus Paclitaxel
Pazopanib daily and weekly Paclitaxel IV.
Drug: Pazopanib plus Paclitaxel
Pazopanib daily and weekly paclitaxel IV
- Objective response rate of pazopanib in combination with paclitaxel [ Time Frame: 2 years ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179269
|Principal Investigator:||Danielle Shafer, DO||Loyola University|
|Principal Investigator:||Cheryl Czerlanis, MD||Loyola University|