Study of Pazopanib and Pemetrexed in Advanced Non-small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00871403|
Recruitment Status : Completed
First Posted : March 30, 2009
Results First Posted : February 16, 2012
Last Update Posted : June 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer, Non-Small Cell||Drug: pazopanib and pemetrexed Drug: pemetrexed and cisplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multicentre, Randomised Phase II Study of Pazopanib in Combination With Pemetrexed in First-line Treatment of Subjects With Predominantly Non-squamous Cell Stage IIIBwet/IV Non-small Cell Lung Cancer|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
Experimental: Arm 1
Investigational treatment (pazopanib and pemetrexed)
Drug: pazopanib and pemetrexed
oral pazopanib 600 mg once daily and pemetrexed intravenous (IV) 500mg/m^2 once every 3 weeks, then pazopanib 800 mg once daily
Active Comparator: Arm 2
Standard treatment (pemetrexed and cisplatin)
Drug: pemetrexed and cisplatin
pemetrexed IV 500 mg/m^2 and cisplatin IV 75 mg/m^2 once every 3 weeks
- Progression-free Survival (PFS) [ Time Frame: Randomization until progression or death (up to 85 weeks) ]PFS is defined as the interval between the date of randomization (date on which the investigator evaluated the participant and first determined he/she had disease progression) and the first occurrence of progressive disease (PD) or death from any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion).
- Overall Survival (OS) [ Time Frame: Randomization until death (up to 85 weeks) ]OS was determined from the date of randomization to the date of death from any cause. Participants who had not died at the time of the cut-off for the final analysis were censored at the date the participants were last known to be alive. Because enrollment in the study was halted prematurely, the ability to achieve an estimate of OS was compromised. Consequently, OS was not estimated.
- Best Overall Response, Assessed as the Number of Participants With the Indicated Tumor Response: Investigator Assessed Only [ Time Frame: Randomization until response or progressive disease (up to 85 weeks) ]Tumor response was assessed by the Investigator according to the RECIST, version 1.0. A participant was defined as a responder if he/she sustained a complete response (CR; the disappearance of all target lesions) or partial response (PR; >=30% decrease in the sum of the longest diameter of target lesions) for at least 4 weeks at any time during randomized treatment. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.
- Percentage of Participants With a Complete Response or a Partial Response [ Time Frame: Randomization until response or progressive disease (up to 85 weeks) ]The percentage of participants with a complete response or a partial response was evaluated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00871403
|GSK Investigational Site|
|Herlev, Denmark, 2730|
|GSK Investigational Site|
|Sutton, Surrey, United Kingdom, SM2 5PT|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|