A Study to Evaluate Pazopanib in Comparison to Pemetrexed in Maintenance Setting in Non-progressing Subjects With Metastatic Stage IVA and IVB Non-squamous Non-small Cell Lung Cancer (NSCLC) Population



Status:Archived
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:February 2011
End Date:May 2014

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A Randomized, Open-label, Phase II, 2-arm Multi-center Trial Comparing Maintenance Therapy With Pazopanib or Pemetrexed in Non-progressing Subjects With Metastatic Stage IVA and IVB Non-squamous Non-small Cell Lung Cancer (NSCLC) After Induction Therapy With Carboplatin or Cisplatin Plus Pemetrexed


This is a Phase II, randomized, open-label, multi-center study in advanced (Stage IVA and
IVB subjects per the International Association for the Study of Lung Cancer (IASLC) 2009
Lung cancer staging schema) non-squamous NSCLC subjects comparing pazopanib relative to
pemetrexed in the maintenance setting. Subjects should have completed 4-6 cycles of
induction therapy with carboplatin or cisplatin plus pemetrexed and have had Stable Disease
(SD), Partial Response (PR) or Complete Response (CR) as the best response to be enrolled
into the study. The primary objective is to estimate the hazard ratio of progression free
survival (PFS) in advanced NSCLC subjects given maintenance therapy of pazopanib (Arm A)
relative to pemetrexed (Arm B). The secondary objectives are: overall survival, response
rates, safety and tolerability. A total of approximately 200 subjects will be enrolled and
randomized in a 1:1 ratio. Safety and efficacy assessments will be regularly performed on
all subjects.



We found this trial at
8
sites
Austin, Texas 78705
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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Chesterfield, Missouri 63017
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Chesterfield, MO
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Kennewick, Washington 99336
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Kennewick, WA
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Las Vegas, Nevada 89102
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Las Vegas, NV
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1 Medical Center Drive
Morgantown, West Virginia 26506
304-598-4800
West Virginia University Hospitals Inc. WVU Healthcare is two corporations, University Health Associates and WVU...
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Morgantown, WV
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Westwood, Kansas 66205
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Westwood, KS
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