A Multi-Center Open Label Phase II Study of Pazopanib in Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer After Progression on First Line Therapy Containing Bevacizumab
This multi-centered phase II trial will examine pazopanib stage IIIB/IV non-squamous NSCLC
patients who have progressed on first-line therapy containing bevacizumab. Treatment should
continue until disease progression, unacceptable toxicity, study withdrawal, or death.
Patients who progress will be treated at the discretion of their physician. all patients
who initiate treatment will be evaluated for disease control rate, which is the primary
endpoint of this study.
The primary objective is to estimate the disease control rate of pazopanib alone in patients
with stage IIIB/IV non-squamous NSCLC who progressed while on bevacizumab. Disease control
rate id defined as complete (CR) + partial response (PR) + stable disease (SD) lasting
greater than or equal to 12 weeks as defined by RECIST.
Secondary Objectives To estimate the combined response rate (CR + PR) of pazopanib according
to RECIST To estimate the progression free survival (defined as time of enrollment until
disease progression or death) and overall survival (defined as time of enrollment until
death) of patients treated with pazopanib.
To evaluate the safety and tolerability of pazopanib using the National Cancer Institute
Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0 To explore potential
correlations between blood biomarkers and clinical response.
Pazopanib is dosed continuously throughout the study. Cycle lengths are identified as 21
days for purposes of the calendar.
The treatment dosage and administration for participating subjects will be, Pazopanib, 800
mg by mouth daily during a 21 day cycle until disease progression.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Best overall response and progression free survival
CR + PR + SD equal to or greater than 12 weeks that will evalute the activity of pazopanib alone in patients with stage IIIB/IV non-squamous NSCLC who have progressed on first line therapy containing bevacizumab
Eight (8) months w additional time for response date to mature
Thomas Stinchcombe, MD
North Carolina Cancer Hospital at University of NC at Chapel Hill
United States: Food and Drug Administration
|University of Pittsburgh Medical Center||Pittsburgh, Pennsylvania 15213|
|Rex Cancer Center at Rex Hospital||Raleigh, North Carolina 27607|
|North Carolina Cancer Hospital at U of North Carolina at CH||Chapel Hill, North Carolina 27599|